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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was previously filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 was previously been entered.
Response to Amendment / Election / Restrictions
Applicant’s amendment filed 7/17/2026 has been entered.
Claims 1-14 and 16-44 remain pending. Claim 15 is cancelled.
Applicant’s election without traverse of Group II (Claims 12-24 and 33) in the reply filed on 12/18/2024 is acknowledged.
Claims 1-11, 25-32, and 34-44 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups/Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/2024.
Claims 12-14, 16-24 and 33 remain pending and are examined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/13/2026 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement is being considered by the examiner.
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 12-24 and 33 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.
Regarding Claim 12, line 5 recites “substantially anatase surface” which renders the claim further indefinite as it is unclear as to what deviations from “anatase” the phrase “substantially anatase” is attempting to encompass.
Claim 17 recites similar limitation as that of Claim 12 and therefore is rendered indefinite for the same reasoning as outlined above.
Regarding Claim 13, the claim recites “said displacing” which renders the claim indefinite as “said displacing” lacks antecedent basis within the claim.
Regarding Claim 18, the claim recites “applying a sodium chloride nano-layer after displacing the organic material”, however, no step of displacing the organic material is claimed previously and lacks antecedent basis and therefore it is unclear what step is being referred to rendering the claim indefinite.
Regarding Claims 14-16, 19-24 and 33, the claims are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as the claims depend from at least one of the claims outlined above.
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.
Claims 12-14, 16, 21-24 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Jin (US Patent 10,857,575-cited in IDS), in view of Denzer (US PGPUB 2004/0210309) and “Superhydrophilic (superwetting) surfaces” (NPL document, see attached PDF) and in further view of Guelzow (US PGPUB 2009/0200198).
Regarding Claim 12, Jin discloses a method of handling a medical implant (10; Figure 2A; Col 1, lines 19-23), the implant (10) comprising a body and having a titanium implant surface (20; Col 6, lines 41-45), said method comprising:
providing a sealable package (80; Figure 2D; note Col 8, line 60 through Col 9, line 3 which outlines a package similar to that of 80 which prevents contaminants and therefore must be sealable to some extent);
providing sufficient energy (i.e. 35 via UV radiation 50; Figure 2D; and via heat treatment showed in Figure 4 and Col 10, lines 16-28; note Col 10, lines 7-15 outline the UV treatment can be readily combined with heat treatment) from the titanium implant surface (20; Col 8, lines 52-59) to provide an anatase surface (Col 10, lines 16-28 disclose heat-based removal of organic/carbonaceous material crystallization annealing the surfaces to form anatase phase of the TiO2);
placing the medical implant (10) in the sealable package (80; Col 8, lines 60-64);
sealing the implant (10) in the sealable package, wherein the sealable package (80) is configured to provide and maintain an atmosphere that is sufficiently low in organic or carbon material such that hydrophilicity of the titanium implant surface decreases due to presence of organic or carbon material by no more than 20% for at least 120 days after sealing the medical implant (10) in the sealable package (80; Col 8, line 52 through Col 9, line 20 describes removing organic contaminants and protecting the device from ambient air and contamination and outlines a package similar to that of 80 which prevents contaminants and therefore must be sealable to some extent; note Col 8, lines 60-61 which discloses “encapsulating” the device 1; the removal of the organic contaminants can be readily viewed as creating at least a low organic atmosphere; see also Col 4, lines 36-46 which discloses based on the treatment, the “super-hydrophilic” properties can be maintained after 3 months of storage and it is noted “superhydrophilic” properties readily assumes a small water contact angle and therefore it can be readily implied that at least 80% hydrophilicity is maintained (therefore 20% or less of a loss of hydrophilicity) if “super-hydrophilic” properties are maintained).
Note: Para. 0059 of the Applicant’s specification outlines that the % hydrophilicity is defined based on the water contact angle associated and the equation of “100 times (X-Y)/X where X is the range of hydrophilicity and Y is the current hydrophilicity, both measured in degrees of water contact angle”. Therefore given the range of hydrophilicity is 0 to 89.9 degrees, a “superhydrophilic” material is commonly known as comprising 0 to 10 degrees of water contact angles (see NPL “Superhydrophilic (superwetting) surfaces”, specifically page 20 section titled “superhydrophilic surfaces”). Therefore, even at the upper end of such range, 100 x ((89.9-10)/89.9) yields approximately 88.9% hydrophilicity.
However, Jin fails to explicitly disclose:
(1) the placing of the implant into the package occurs within 2 hours after forming the substantially anatase surface,
(2) the sealing the implant in the package occurs within about 2 to 60 minutes after placing the medical implant in the sealable package,
(3) providing an absorbent or adsorbent within the sealable package to actively attract and bind carbon gas present in the sealable package to reduce and/or eliminate carbon gas within the sealable package after sealing.
First, attention is brought to Denzer which teaches a method of handling a medical implant (“implants”; Para. 0001) having a titanium implant surface (Para. 0002), comprising:
displacing organic material/providing energy using UV radiation (Paras. 0016-0017);
placing and sealing the medical implant in a sealable package (“envelope”; Para. 0020) after the displacing; and
further teaches that the hydrophilic character of the treated implant remains unchanged for a reasonable time of one hour and therefore, if the implant is to be implanted within an hour, no packaging is necessary (see Para. 0025). Therefore it is at least implied that the implant is placed (and sealed) in the disclosed packaging/envelope at any time around or over an hour.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Jin to place and seal the implant within the package within hour after displacing as taught by Denzer. By modifying Jin in this manner, the hydrophilic surface and its biological activity can be maintained substantially unchanged as taught by Denzer (Para. 0006) to be used at a later time beyond an hour, as such treated surfaces begin to change beyond an hour of time when not packaged as taught by Denzer (Para. 0025).
Secondly, attention can be brought to the teachings of Guelzow which includes another implant handling method including placing an implant (device 24; Figure 3; see Para. 0043 which notes implant like articles such as a stent) within a sealable package (10) and further placing an absorbent (26) into the package (10) to actively attract and bind carbon gas present in the sealable package (10) to reduce and/or eliminate carbon gas within the sealed package (10; Para. 0017, 0039), providing the sealable package (10) with a main compartment (32) for holding the medical implant (24) and a secondary compartment (30) for holding the absorbent (26; Para. 0017).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized a multi-compartmented package and absorbent as taught by Guelzow in the implant handling system and method of Jin. By modifying Jin in this manner, the implant can be protected (via controlling environment therein) by the absorbent without being in physical contact therewith as taught by Guelzow (Para. 0040). Further, with such multi-compartmented package, the absorbent and implant can be separately removed from the package without opening the other sealed compartment.
Regarding Claim 13, Jin, as modified, discloses the displacing includes exposing the medical implant to UV light (50; Col 8, lines 52-59).
Regarding Claim 14, Jin, as modified, discloses sterilizing the sealed package (80; Col 9, lines 10-20; note that in order for the package to not contaminate the implant, the package benefits from also being sterilized).
Regarding Claim 16, Jin, as modified, Guelzow discloses said providing a sealable package includes providing a sealable package with a main compartment (32) for holding the medical implant (24) and a secondary compartment (30) for holding the absorbent (26; Para. 0017).
Regarding Claims 21-24, Jin, as modified, discloses flushing the package (80) with an inert gas or a carbon displacing gas (Col 9, lines 4-7 disclose the package being “pre-filled” with such gas) specifically with Argon or Nitrogen gas or a carbon free gas (Col 9, lines 3-7), wherein such flushing must occur after the implant is placed in order for the gas to “further protect” the implant as outlined by Jin (the gas that is placed therein will continually flush out the oxygen until sealing).
However, although Jin discloses inserting a flushing gas, Jin does not disclose when in the process such gas is flushed into the package other than while the article is placed therein. Specifically Jin does not disclose flushing prior to placing and sealing the medical implant (10) into the package (80) or prior to placing the medical implant (10) into the package and after placing the medical implant (10) into the package (80).
Attention can be brought to the teachings of Guelzow which includes another implant handling method including flushing compartments (30, 32; Figure 3) of a package (10; Figure 3) prior to filling the compartments with the implant and absorbent (26; Para. 0039-0041; see Figures 8-9).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have further modified Jin to include a flushing step prior to placing the implant and absorbent in the package as taught by Guelzow. By flushing the package before and after filling the package, the sterility of both the package and the implant to be packaged can be further increased.
Regarding Claims 33, Jin, as modified, discloses providing the titanium implant surface (20) of the medical implant (10) with a plurality of TiO2 nanotubes formed thereon (i.e. Col 3, lines 1-5 and Col 6, lines 41-45).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jin (US Patent 10,857,575-cited in IDS), in view of Denzer (US PGPUB 2004/0210309), “Superhydrophilic (superwetting) surfaces” (NPL document), and Guelzow (US PGPUB 2009/0200198), as applied to Claim 12, and in further view of Strom (US PGPUB 2006/0217778)
Regarding Claim 18, Jin, as modified, discloses several features of the claimed invention but does not disclose comprising applying a sodium chloride nano-layer after displacing the organic material but prior to placing the medical implant in the sealable pack.
Attention can be brought to the teachings of Strom which discloses medical device including a titanium surface (of electrode 54; Figure 5) that further comprises coating including a sodium chloride material (Para. 0028).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have included a sodium chloride layer as taught by Strom on the implant of Jin as such a layer would readily further protect the surface and prevent contamination thereof as taught by Strom (see Para. 0028). Further it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have applied such a nano-layer after the displacing to ensure the contaminants are removed and prior to the placing of the implant in order to the- package as it would be more difficult to apply such while in a package.
Allowable Subject Matter / Examiner’s Note
Claim 17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 19-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 19, Jin (US Patent 10,857,575-cited in IDS), as modified, discloses several features of the claimed invention (refer to the rejection of Claim 12 above) but does not readily disclose storing the sealed package in a larger airtight container with a second absorbent or adsorbent. Specifically, none of the prior art discloses an absorbent or adsorbent in the sealed package and a further absorbent or adsorbent in a larger container in which the sealed package is stored therein. DelDuca (US Patent 5,811,142) and Guelzow disclose absorbent or adsorbents but neither discloses an absorbent or adsorbent in the sealed package and in a larger airtight container in which the sealed package is placed therein.
These features in combination with the other claimed features render the claims allowable subject matter.
Response to Arguments
Applicant's arguments filed 7/17/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments with respect to the prior art rejections that:
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Examiner respectfully asserts that whether or not the hydrophilicity is being restored or degradation is being prevented in Jin does not preclude Jin from disclosing features of the claimed invention as outlined above. Regardless, the methods of Jin are clearly directed to preventing degradation after/during storage as outlined throughout the disclosure (i.e. Col 4, lines 36-46, Col 5, lines 35-38, Col 11, lines 37-63). Jin also discloses several techniques as outlined by the NPL document by Wang to allow for such preservation of hydrophilicity as outlined above and further Guelzow is applied for a further teaching of carbon/decontaminate removal.
Further, in response to Applicant’s arguments with respect to the prior art rejections that:
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Examiner respectfully asserts in response to Applicant's argument that there is no suggestion to combine the references, the Examiner recognizes that references cannot be arbitrarily combined and that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references. In re Nomiya, 184 USPQ 601 (CCPA 1915). However, there is no requirement that a motivation to make the modification be expressly articulated. The test for combining references is what the combination of disclosures take as a whole would suggest to one of ordinary skill in the art. In re McLaughlin, 110 USPQ 209 (CCVA 1971). References are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures. In re Bozek, 163 USPQ 545 (CCPA. 1969).
In this case, Jin outlines removing carbon based contaminants and further preventing passage of air and contaminants from reaching the medical device within packaging thereof (i.e. see Col 8, line 65 through Col 9, line 14) while Guelzow teaches an absorbent for further removing carbon contaminants from a medical device package for providing a controlled sterile environment and protecting the device from further contaminants (Para. 0040). Therefore while Jin already discloses maintaining “superhydrophilic” properties of the implant during storage, this would not preclude one of ordinary skill in the art from utilizing the absorbent as taught by Guelzow to further assist in maintaining such properties by further protecting the device (maintaining sterile environment) as outlined in the rejection above. Merely because Guelzow teaches the purpose of removing contaminants is for maintaining sterility would not have precluded one of ordinary skill in the art in possession of the invention of Jin from being motivated to further use an absorbent as taught by Guelzow to further remove the contaminants which would also readily assist in maintaining the hydrophilicity thereof.
Regarding Applicant’s arguments with respect to the prior art rejections that:
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Examiner respectfully refers to Examiners comments above as it is again noted that merely because Jin already discloses maintaining “superhydrophilic” properties of the implant during storage, this would not preclude one of ordinary skill in the art from utilizing the absorbent as taught by Guelzow to further assist in maintaining such properties by further protecting the device (maintaining sterile environment) as outlined in the rejection above.
Regarding Applicant’s arguments with respect to the prior art rejections that:
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Examiner respectfully asserts that merely because Applicant uses the absorbent for a different purpose does not alter the conclusion that its use in a prior art device would be prima facie obvious from the purpose disclosed in the reference." In re Lintner, 173 USPQ 560. Specifically in this instance, merely because Guelzow teaches use of an absorbent for drug efficacy would not have precluded one of ordinary skill in the art from being motivated to incorporate such an absorbent which is also utilized for protecting the device packaged from organic contaminants. Although such teachings of Guelzow do not pertain to enhancing hydrophilicity, the absorbent thereof is readily used to control/remove contaminants from contact with the object packaged over time which is well known in the art of packaging.
Lastly, in response to Applicant’s further arguments that:
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Examiner respectfully asserts that while Jin does disclose restoring such hydrophilic properties, Jin is also clearly directed to preventing degradation after/during storage with the processes as outlined throughout the disclosure (i.e. Col 4, lines 36-46, Col 5, lines 35-38, Col 11, lines 37-63) and explicitly outlines that storage of such Ti based materials is a problem with respect to maintaining such hydrophilic properties (Col 5, lines 35-60) and provides treatment solutions of the surfaces thereof to obtain and maintain such properties during storage (Col 4, lines 36-46 which discloses based on the treatment, the “super-hydrophilic” properties can be maintained after 3 months of storage).
With respect to the modification in view of Guelzow, see Examiner responses above.
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 JOSHUA G KOTIS whose telephone number is (571)270-0165. The examiner can normally be reached Monday - Thursday 6am-430pm.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 8/19/2026
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