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 .
Election/Restrictions
Applicant's election with traverse of claims 9-20 in the reply filed on 7/20/2026 is acknowledged. The traversal is on the ground(s) that (i) a search of both inventions necessarily overlaps; and (ii) examination of both inventions does not place an undue burden on the Primary Examiner. This is not found persuasive because:
I. A search of both inventions does not necessarily overlap.
“Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together.” MPEP § 802.02. Here, for example, elected Invention II requires merely “a guidewire substrate,” whereas Invention I requires “a guidewire substrate comprising stainless steel, surgical steel, nitinol, or CoCrMo alloy.” A search for Invention II must include searching the specific species of substrate, but a search for Invention I does not. Thus, a prior art reference teaching an aluminum alloy guidewire (see, e.g., KR 20200040078 A) would read on Invention II but not Invention I. Consequently, because a search for Invention I requires a difference search query than Invention II to yield relevant art, the Primary Examiner’s burden of showing a serious search burden has been met.
II. Examination of both inventions places and undue burden on the Primary Examiner.
“To demonstrate serious examination burden separate from a serious search burden, the examiner must show by appropriate explanation that the inventions are likely to raise serious examination issues, such as non-prior art issues . . . . In this situation, a serious examination burden may exist where issues relevant to one invention are not relevant to the other invention.” Id. Here, the burden on the Primary Examiner further extends to the patentability issues associated with, and evolving as a result of, searching both inventions. Issues related to a coating process are frequently very different from those related to a coated article. For example, the issues related to the structural requirements or use of the article need not be familiar to an examiner of specific processes. Consequently, a serious examination burden exists as well.
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) Status
Claims 1-20 are pending as filed 12/12/2023.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/20/2026.
Priority
The instant application claims benefit of U.S. provisional application 63/432,206, filed 12/13/2022. Upon review of this provisional application, the Primary Examiner has determined that all elected claims are fully supported therein and the effective filing date of elected claims 9-20 is 12/13/2022. See MPEP § 2133.01 (“The effective filing date of a claimed invention is determined on a claim-by-claim basis and not an application-by-application basis.”).
Information Disclosure Statement
While not required, no IDS has been filed to date in this application.
Drawings
The drawings filed 12/12/2023 are acceptable. See MPEP § 608.02(b)(I).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 20200040078 A (“KR 078;” reference made to English-language machine translation) in view of US 2009/0211909 A1, and further in view of any one of Veeraraghavan et al., Synthesis and characterization of a novel non-chrome electrolytic surface treatment process to protect zinc coatings, Surface and Coating Technology 167 (2003) 41-51 (“Veeraraghavan”); or Dalbin et al., Silica-based coating for corrosion protection of electrogalvanized steel, Surface & Coatings Technology 194 (2005) 363-371 (“Dalbin”); or Occidental Chemical Corporation, The OxyChem Sodium Silicates Handbook (2019), https://www.oxychem.com/siteassets/documents/other-essentials/sodium-silicates-handbook.pdf, retrieved Oct. 9, 2026 (“OxyChem”).
Claim 9
KR 078 teaches a process for coating a medical metal [0001], which can be a guidewire [0002], comprising:
(b) contacting the guidewire substrate with a curable film-forming composition comprising an aqueous solution of sodium silicate to form a coating layer on the guidewire [0030].
The silicate layer acts as a medium to ensure that a later-deposited inorganic film adheres to the surface of the wire without peeling off, while also providing corrosion resistance to the wire [0032].
KR 078 does not teach: (a) cleaning the guidewire substrate; or (c) subjecting the guidewire and the film forming composition to a temperature of at least 120°C for a time sufficient to effect cure and form a coated medical guidewire.
With respect to (a), US 909 teaches a process for coating a medical guide wire made of aluminum, the same material as the wire of KR 078 [0014]. Specifically, US 909 teaches that the medical guide wire is mechanically, chemically, and/or laser treated to clean and roughen the surface of the wire to improve the adhesion of the coating thereto [0075]. It would have been obvious to one of ordinary skill in the art to modify the process of KR 078 so as to mechanically, chemically, and/or laser treat the surface of the medical guide wire before application of the silicate coating thereto. One of ordinary skill in the art would have been motivated to do so in order to improve the adhesion of the silicate coating to the wire. See MPEP § 2143(I)(A).
With respect to (c), Veerararghavan teaches a process for electrolytically depositing a sodium silicate coating on a metallic substrate, the same process as KR 078 [§2]. Veerararghavan further teaches that post-treatment drying [abstract] is the primary factor for improving corrosion resistance by decreasing the presence of cracks on the surface of the coating [§3.5]. Temperatures “greater than 100°C” show better corrosion stability and “heating samples at 175°C shows promise in stabilizing the surface coating and keeping the [corrosion] resistance high” [id.]. Moreover, Veerararghavan teaches temperatures as high as 200°C show increased corrosion resistance [id.].
Dalbin also teaches a process for electrolytically depositing a sodium silicate coating on a metallic substrate, the same process as KR 078 [§2]. Dalbin teaches that drying temperatures of 80-165°C result in higher corrosion resistance, “but higher temperatures did not cause further improvement” [§3.3], yet there is no examples in Dalbin greater than 160°C [Fig. 7].
OxyChem teaches that aqueous sodium silicate solutions in general, when applied as coatings, can be dried at temperatures as high as 300-700°F (approx.. 149-371°C) [p. 8].
It would have been obvious to one of ordinary skill in the art, based on the teachings of any one of Veerararghavan, Dalbin, or OxyChem to post-heat the sodium silicate coating of KR 078 in view of US 909 at a temperature of 120°C, including temperatures as high as approx. 371°C, such as above 175°C, above 200°C, or up to 165°C. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully increasing the corrosion resistance of the silicate coating, a key function of the coating desired by KR 078.
Moreover, it is clear from the cited prior art that the heating temperature is a result-effective variable, with higher temperatures (at least as high as 200°C, based on Dalbin) resulting in improved corrosion resistance of the silicate coating, a key function of the coating desired by KR 078. Consequently, it would have been obvious to one of ordinary skill in the art to optimize the temperature by routine experimentation. See MPEP § 2144.05(II).
Claims 15 & 16
None of the cited prior art teaches that the sodium silicate film-forming composition additionally includes the claimed fluorosurfactant or polyethylene oxide polymer.
Nevertheless, it is the Primary Examiner’s position that it would have been obvious to one of ordinary skill in the art to add any known, conventional additives or film-forming components that would impart desirable characteristics to the surface coating on the wire, e.g., lubricity.
Claim(s) 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 20200040078 A (“KR 078;” reference made to English-language machine translation) in view of US 2009/0211909 A1, and further in view of any one of Veeraraghavan et al., Synthesis and characterization of a novel non-chrome electrolytic surface treatment process to protect zinc coatings, Surface and Coating Technology 167 (2003) 41-51 (“Veeraraghavan”); or Dalbin et al., Silica-based coating for corrosion protection of electrogalvanized steel, Surface & Coatings Technology 194 (2005) 363-371 (“Dalbin”); or Occidental Chemical Corporation, The OxyChem Sodium Silicates Handbook (2019), https://www.oxychem.com/siteassets/documents/other-essentials/sodium-silicates-handbook.pdf, retrieved Oct. 9, 2026 (“OxyChem”), as applied to claim 9 above, further in view of WO 2012/149382 A1 (“WO 382”).
Claim 14
None of the cited prior art explicitly teaches that the sodium silicate is present in the curable film-forming composition in an amount of 5-15 wt.-%, based on the total weight of the curable film-forming composition.
“Generally, differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical.” MPEP § 2144.05(I) (citation omitted).
Moreover, WO 382 teaches that, in the electrochemical treatment of a wire, “electrolyte compositions . . . may be adjusted” to achieve the desired finished wire dimensions [0020]. Based on this teaching, it is the Primary Examiner’s position that the sodium silicate composition is a result-effective variable that it is known in the art to adjust in order to arrive at a desired finished wire dimension (here, e.g., coating thickness).
Consequently, it would have been obvious to one of ordinary skill in the art to optimize the concentration of sodium silicate in the coating bath by routine experimentation, absent evidence of criticality. See MPEP § 2144.05(II).
Claim 17
None of the cited prior art explicitly teaches that the sodium silicate is formed by immersion and that the guide wire is removed from the coating solution at a rate of up to 15 cm/min.
It is the Primary Examiner’s position that electrolytic coating is commonly performed by immersing the substrate in a bath of the coating composition. The substrate must be withdrawn at a certain rate and that rate is a result-effective variable because the wire must be withdrawn slowly enough to allow sufficient coating material to be retained on the wire, but not so slowly as to deleteriously affect the efficiency of the process. For example, WO 382 teaches that, in the electrochemical treatment of a wire “wire speeds . . . may be adjusted” to achieve the desired finished wire dimensions [0020]. Based on this teaching, it is the Primary Examiner’s position that the wire withdrawal rate is a result-effective variable that it is known in the art to adjust in order to arrive at a desired finished wire dimension (here, e.g., coating thickness).
Consequently, it would have been obvious to one of ordinary skill in the art to optimize the wire withdrawal rate by routine experimentation, absent evidence of criticality. See MPEP § 2144.05(II).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 078 in view of US 909, in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, as applied to claim 9 above, further in view of US 2006/0271135 A1 (“US 135”).
Claims 10-11
The combined teaching of KR 078 in view of US 909, and in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, is detailed above.
None of these prior art references explicitly teaches either of cleaning methods (i) or (ii) recited in claim 10.
US 135 teaches a process for coating a metal wire substrate, that can be aluminum and used as a medical device component (like the guidewire of KR 078 and US 909) [0055]. In preparation for coating, the wire is cleaned with an alkaline solution [0029].
It would have been obvious to one of ordinary skill in the art to modify the process of KR 078 in view of US 909, and in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem so as to, in particular, clean the wire utilizing an alkaline solution, as taught by US 135. One of ordinary skill in the are would have been motivated to do so by the desire and expectation of successfully cleaning and preparing the wire to receive the silicate coating.
None of the cited prior art explicitly teaches that the alkaline solution is aqueous. Nevertheless, it is the Primary Examiner’s position that aqueous alkaline solutions, such as those produced from inorganic salts (e.g., KOH) are well known in the art. Moreover, utilizing an aqueous solution has the added advantage of being more environmentally than utilizing a organic solvent-based solution. Consequently, it would have been obvious to one of ordinary skill in the art to provide the alkaline solution of US 135 as an aqueous solution for these reasons.
None of the cited prior art explicitly teaches the optional step of rinsing with water. It is the Primary Examiner’s position that this is also well known in the cleaning and coating art to remove any salt and/or mineral residue that could interfere with the coating process. Consequently, it would have been obvious to one of ordinary skill in the art to optionally rinse the alkaline-cleaned wire with water for this reason.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 078 in view of US 909, in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, as applied to claim 9 above, further in view of CN 113908408 A (“CN 408”) in view of WO 382.
Claim 10
The combined teaching of KR 078 in view of US 909, and in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, is detailed above.
None of these prior art references explicitly teaches either of cleaning methods (i) or (ii) recited in claim 10.
CN 408 teaches, in a process for treating a medical guide wire, using an electrolytic treatment to clean the wire [claim 1].
Because CN 408 demonstrates that electrolytic cleaning is a known cleaning method in the art, it would have been obvious to one of ordinary skill in the art to modify the process of KR 078 in view of US 909, and in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, to clean the wire by immersion in an electrolytic bath. One of ordinary skill in the art would have been motivated by the desire and expectation of successfully using this known means to accomplish cleaning of the wire. See, e.g., MPEP § 2143(I)(A).
None of KR 078, US 909, Veeraraghavan, Dalbin, or OxyChem teach applying a voltage of 2-100 V to the guide wire to achieve electrochemical cleaning. WO 382 identifies, in the electrochemical treatment of a wire, that “applied potential . . . may be adjusted” [0020]. Based on this teaching, it is the Primary Examiner’s position that the applied voltage is a result-effective variable that it is known in the art to adjust.
Consequently, it would have been obvious to one of ordinary skill in the art to optimize the applied voltage by routine experimentation, absent evidence of criticality. See MPEP § 2144.05(II).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 078 in view of US 909, in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, further in view of CN 408 in view of WO 382, as applied to claim 10 above, further in view of Aluminum Surface Cleaning – A Brief Overview, Innoval, https://www.innovaltec.com/aluminium-surface-cleaning-overview-blog/, Jul. 13, 2018, last visited Oct. 13, 2026 (“Innoval”).
Claims 12-13
The combined teaching of KR 078 in view of US 909, and in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, further in view of CN 408 and WO 382, is detailed above.
None of these prior art references explicitly teaches that the aqueous electrolytic solution includes a mineral acid, specifically sulfuric acid.
Nevertheless, Innoval teaches that “[a]cids like sulfuric acid . . . [are] relatively good cleaning agents on their own” for aluminum surfaces (the guide wire of KR 078 being Al). Innoval further teaches “electrolysis can further increase [the acid’s] cleaning power.”
It would have been obvious to one of ordinary skill in the art to modify the process of KR 078 in view of US 909, in view of any one of Veeraraghavan et al., or Dalbin et al., or OxyChem, further in view of CN 408 in view of WO 382 so as to utilize, in the electrochemical cleaning bath, sulfuric acid. One of ordinary skill in the art would have been motivated to do so by the desire and expectation of successfully cleaning the Al wire of KR 078 since electrolytic cleaning of Al surfaces with sulfuric acid is known. See MPEP § 2143(I)(A).
Claim Rejections - 35 USC § 102
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 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(s) 20 is/are rejected under 35 U.S.C. 102(A)(1) as being anticipated by KR 078.
Claim 20 is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, 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 as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). If the process limitation connotes specific structure and may be considered a structural limitation, however, that structure should be considered. In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). See also In re Nordt Dev. Co., 881 F.3d 1371, 1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018). Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the Applicant to show a non-obvious difference. MPEP § 2113(II).
It is the Primary Examiner' s position that the structure implied by the process steps of claim 20 is a medical guide wire having a cured sodium silicate coating thereon. As such, KR 078 anticipates the claimed guidewire despite the fact that KR 078 does not explicitly teach method steps (a) or (c), as noted above. The Primary Examiner notes that the claimed heating-to-cure could impart specific structure to the silicate coating, as acknowledged by Veerararghavan and Dalbin, but no particular properties are recited in claim 20 and nothing in the record makes any properties inherent. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (“Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.”).
Allowable Subject Matter
Claims 18 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is of record. The prior art neither teaches nor suggests the claimed process including the additional process step (d) of applying a hydrophobic coating layer to the cured (silicate) coating layer, wherein the hydrophobic coating layer is prepared from a composition comprising a fluoroalkylether siloxane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM P FLETCHER III whose telephone number is (571)272-1419. The examiner can normally be reached Monday-Friday, 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WILLIAM PHILLIP FLETCHER III
Primary Examiner
Art Unit 1759
/WILLIAM P FLETCHER III/Primary Examiner, Art Unit 1759
13 October 2026
