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 .
Claim Status
Applicants’ September 1, 2026 response to the June 1, 2026 Non Final Rejection is acknowledged. Claims 8, 9, 13-17, 19 and 20 are pending, claim 8 is independent. Any rejections and/or objections, made in the previous Office Action, and not repeated below, are hereby withdrawn.
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.
Claims 8, 9, 13-17, 19 and 20 are rejected under 35 U.S.C. 112(a), 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.
Regarding claim 8, finishing sufficient to remove “at least 2 mils of material from the casting surfaces” is not supported as broadly as amended. Applicant allows for specific finishing types that are narrower than “finishing” that remove that much material, or removing impurities to that depth broadly by “finishing” but “finishing” to that depth is not as a whole supported.
Regarding claims 9, 13-17, 19 and 20, these claims are rejected for their incorporation of the above due to their respective dependencies on claim 8.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 8, 9, 13-17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabot et al. (US2011/0284381 A1), hereinafter Cabot, in view of Fuk et al. (EP 1980651 A2), hereinafter Fuk, further in view of Akiba et al. (JP 2004/290575 A, herein referring to the Google Patents machine translation of May 25, 2026), hereinafter Akiba (all of record)
Regarding claims 8 and 9, Cabot teaches a microcrystalline anodic coated article including a medical container (medical housing; [0038]), anodized aluminum substrate with microcrystalline aluminum oxide on it (claim 1; [0005]) with an anodized coating of at least 0.05 mm ([0050]; thickness of about 1.97 mil) and the anodized coating has a fading of change in L* of less than about 1.5 a change in a* of less than about 2.0 and a change of b* of less than about 2.5 over time ([0049]), this is a type of color uniformity.
Cabot does not specifically teach the medical device is a scope, nor the claimed alloy composition (Si ≤ 0.3% and Zn of at least 5%, nor 7-8% Zn, 0.2% Mg, 0.4-1% Cu and 0.2-0.3% Si).
Fuk is in a similar field of endeavor of anodized oxide layer on aluminum material (claim 1) and teaches the aluminum alloy includes amounts of Si that overlap that claimed (including 0.25 wt% and 0.2-0.6 wt%; Table 1 and [0042]), more than 7 wt.% zinc ([0043]), copper including amounts that overlap that claimed (ex. 0.5-0.9 wt%, 0.50-1.1 wt%, 0.7-1.2 wt% etc.; Table 1; [0039]) and magnesium including amounts that overlap that claimed ([0040]; Table 1; ex. 0.20-0.8 wt%).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention to modify Cabot with the alloy of Fuk. The motivation for doing so would have been simple substitution of one known element for another to obtain predictable results (MPEP 2143 I B). The prior art of Cabot contained a product differed from the claimed product by the steel alloy specifics (finding 1). The alloy was known in Fuk (see above), and the functions of elements in aluminum alloys are well understood to one of ordinary skill in the art (finding 2). One of ordinary skill in the art would look to related prior art for details of an alloy and the elements of aluminum alloys are predictable when substituted (finding 3).
Akiba is in a similar field of endeavor of an aluminum alloy on a body that has a coating by alumite treatment (anodized; [0010]) and teaches wherein the body is for an endoscope ([0010]-[0012]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention to further modify Cabot with medical device of Akiba. The motivation for doing so would have been simple substitution of one known element for another to obtain predictable results (MPEP 2143 I B). The prior art of Cabot contained a product differed from the claimed product by the specific medical device (finding 1). Aluminum alloy with anodized layer is known for medical scopes (see above), and the functions anodized aluminum are well known in the art(finding 2). One of ordinary skill in the art would look to related prior art for details of the type of medical device, and these are predictable when substituted (finding 3).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, (MPEP 2144.05 I). The proportions disclosed by the prior art overlap applicants claimed proportions and therefore establish a prima facie case of obviousness, where one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to select from the proportions disclosed by the prior art, including those proportions, which satisfy the presently claimed requirements (MPEP 2144.05 I). As of the writing of this Office Action, no objective evidence of criticality to the claimed ranges has been presented.
Regarding “A product-by process”, “providing a molten casting aluminum alloy, ”providing an investment casting mold, casting the aluminum alloy in the mold to create the housing and removing the mold from the housing; post-machining the housing to meet a desired specification” (examiner notes that “to meet a desired specification” is broad and could be literally anything including “as molded”), “after post-machining the housing, performing surface finishing sufficient to remove impurities on casting surfaces by at least 2 mils” (as there’s no starting depth, this could again under broadest reasonable interpretation be any thickness etc.), and “coating the housing” is all product-by-process language where the statutory category of the claim is the product. Product-by-process claims are limited by and defined by the process, however, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP 2113. In this instance, the patentable distinction structurally of the above language and the rest of the claim limitations is a medical scope housing of aluminum alloy with Si at ≤0.3% and at least 5% Zn, with a micro-crystalline aluminum anodic coating of at least 0.6 mil thickness, addressed above.
Regarding claims 13 and 14, Cabot in view of Fuk and Akiba teaches each limitation of claim 8, as discussed above. Cabot further teaches anodized aluminum substrate with microcrystalline aluminum oxide on it (claim 1; [0005]) with an anodized coating of at least 0.05 mm ([0050]; thickness of about 1.97 mil). One of ordinary skill in the art reasonably understands a thickness of about 1.97 mil to overlap with 1.9 mils. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, (MPEP 2144.05 I). The proportions disclosed by the prior art overlap applicants claimed proportions and therefore establish a prima facie case of obviousness, where one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to select from the proportions disclosed by the prior art, including those proportions, which satisfy the presently claimed requirements (MPEP 2144.05 I). As of the writing of this Office Action, no objective evidence of criticality to the claimed ranges has been presented.
Regarding after the surface finish step, bead blasting the component with a bead media (#10 size glass or #220 size aluminum oxide), this is all product-by-process language where the statutory category of the claim is the product. Product-by-process claims are limited by and defined by the process, however, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP 2113. In this instance, the patentable distinction structurally of the above language and the rest of the claim limitations is a micro-crystalline aluminum anodic coating with a thickness of 1.5-1.9mils, addressed above.
Regarding claim 15, Cabot in view of Fuk and Akiba teaches each limitation of claims 8 and 9, as discussed above. Regarding “after the surface finish step, bead blasting the housing and then performing a bright dip of the housing with a solution comprising phosphoric acid and nitric acid”, this is a product-by process limitation. Further, the examiner notes this language is exceptionally broad no time, or size or other parameters are included for bead blasting, and no details of the bright dipping regarding temperature or time are provided. Product-by-process claims are limited by and defined by the process, however, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP 2113. In this instance, no further structural limitation is presented beyond that addressed in claim 8, above.
Regarding claim 16, Cabot in view of Fuk and Akiba teaches each limitation of claim 8, as discussed above. Cabot further teaches anodized aluminum substrate with microcrystalline aluminum oxide on it (claim 1; [0005]) with an anodized coating of at least 0.05 mm ([0050]; thickness of about 1.97 mil). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, (MPEP 2144.05 I). The proportions disclosed by the prior art overlap applicants claimed proportions and therefore establish a prima facie case of obviousness, where one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to select from the proportions disclosed by the prior art, including those proportions, which satisfy the presently claimed requirements (MPEP 2144.05 I). As of the writing of this Office Action, no objective evidence of criticality to the claimed ranges has been presented.
Regarding claim 17, Cabot in view of Fuk and Akiba teaches each limitation of claim 8, as discussed above. Cabot further teaches anodized aluminum substrate with microcrystalline aluminum oxide on it (claim 1; [0005]) with an anodized coating of at least 0.05 mm ([0050]; thickness of about 1.97 mil). One of ordinary skill in the art reasonably understands a thickness of about 1.97 mil to overlap with 1.9 mils. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, (MPEP 2144.05 I). The proportions disclosed by the prior art overlap applicants claimed proportions and therefore establish a prima facie case of obviousness, where one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to select from the proportions disclosed by the prior art, including those proportions, which satisfy the presently claimed requirements (MPEP 2144.05 I). As of the writing of this Office Action, no objective evidence of criticality to the claimed ranges has been presented.
Regarding claim 19, Cabot in view of Fuk and Akiba teaches each limitation of claim 8, as discussed above. Cabot further teaches anodized aluminum substrate with microcrystalline aluminum oxide on it (claim 1; [0005]). Regarding the testing specifics of claim 19, this is functional language, where the feature of testing is defined by what it does, rather than what it is (MPEP 2173.05 (g)). The structural and property limitations (the failure mode itself is a property limitation) of the claims shall be considered for patentable distinction, as the testing method itself is functional language which does not distinguish over the prior art (claims cover what a device is, not what a device does; MPEP 2114 II).
Regarding the processing steps within the testing method functional language, the examiner acknowledges these steps are not a positive recitation of the article as claimed, merely a part of the test method (itself functional language as discussed above). The results of the test method are positively recited (failure mode) and as such are claim limitations addressed in the below.
The prior art teaches the claimed product, and products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (MPEP 2112.02 II). Therefore, the claimed failure mode properties are inherent to the product as rejected above.
Regarding claim 20, Cabot in view of Fuk and Akiba teaches each limitation of claim 8, as discussed above. Cabot further teaches a microcrystalline anodic coated article including a medical container and handle (medical housing; [0038]), anodized aluminum substrate with microcrystalline aluminum oxide on it (claim 1; [0005]). Cabot does not specifically teach a scope is the medical device.
Akiba is in a similar field of endeavor of an aluminum alloy on a body that has a coating by alumite treatment (anodized; [0010]) and teaches wherein the body is for an endoscope (medical) ([0010]-[0012]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention to further modify Cabot with medical device of Akiba. The motivation for doing so would have been simple substitution of one known element for another to obtain predictable results (MPEP 2143 I B). The prior art of Cabot contained a product differed from the claimed product by the specific medical device (finding 1). Aluminum alloy with anodized layer is known for medical scopes (see above), and the functions anodized aluminum are well known in the art(finding 2). One of ordinary skill in the art would look to related prior art for details of the type of medical device, and these are predictable when substituted (finding 3).
Regarding after applied together in the same set of process conditions and in a common electrolytic tank, this is product-by-process language where the statutory category of the claim is the product. Product-by-process claims are limited by and defined by the process, however, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP 2113. In this instance, the patentable distinction structurally of the above language and the rest of the claim limitations is a micro-crystalline aluminum anodic coating on a housing and handle, addressed above.
Response to Arguments
Applicants’ amendments and arguments, filed September 01, 2026, with respect to 35 U.S.C. 112(b) claim rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of June 1, 2026 has been withdrawn.
Regarding the obviousness rejections of record, applicant's arguments filed September 1, 2026 have been fully considered but they are not persuasive. Applicant argues the prior art does not teach the claimed color difference, which is not correct, Cabot teaches the anodized coating has a fading of change in L* of less than about 1.5 a change in a* of less than about 2.0 and a change of b* of less than about 2.5 over time ([0049]), this is a type of color uniformity, and therefore meets the claim limitation as presently recited. Applicant further argues the criticality of the process, but provides only general citations, nothing that specifically notes distinctive structural characteristics that are necessarily formed by the product; therefore, these arguments are not persuasive. Applicants’ “suggest” that a result (common coating giving a matched appearance” with no supporting evidence or citations; this is not persuasive.
Applicant further alleges that wrought aluminum alloys are not substitutable with casting alloys, but does not provide any evidence of this; therefore, these arguments are not persuasive. Fujita teaches overlapping ranges known in the aluminum alloy art to those claimed, and this is a reason to consider them obvious.
Regarding arguments to the thickness, applicant has not provided evidence from Cabot or their own specification that shows a criticality of 1.9 mils. The prior art teaches a thickness of at least about 0.05 mils (noted above as “about 1.97 mils”), “about” 1.97 mils is considered to overlap with 1.9 mils by virtue of the word “about” in Cabot. Whether the unexpected results are the result of unexpected improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support (MPEP 716.02(d)). To establish the unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed ranges to show the criticality of the claimed range (MPEP 716.02(d),II). This burden has not been met by applicant, and arguments to the contrary are not persuasive.
For these reasons, and for those reasons as advanced in the rejections above, the present claims are not found to distinguish over the prior art and this action is made FINAL.
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 KATHERINE CHRISTY whose telephone number is (303)297-4363. The examiner can normally be reached Monday-Thursday, 7am-4pm MT.
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/KATHERINE A CHRISTY/Primary Examiner, Art Unit 1784
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