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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 has been entered.
Response to Amendment / Election / Restrictions
Applicant’s amendment filed 12/12/2025 has been entered.
Claims 1-44 remain pending.
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Claims 1-11, 25-32, and 34-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups/Inventions, there being no allowable generic or linking claim.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 12-24 and 33 remain pending and are examined below.
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, the claim recites “wherein the low organic or carbon atmosphere or organic-free or carbon gas-free atmosphere 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 in the sealable package ”. This limitation renders the claim indefinite as it is unclear as to what further limitation this recitation is attempting to encompass. It is first unclear as to what “low organic or carbon atmosphere” is intending to encompass”. Applicant appears to attempt to define such an amount with the subsequent “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”. However, this does not readily provide a definite boundary of the term “low”. It is unclear as several factors including temperature and storage conditions, etc. would readily affect the properties of the stored implant thereby affecting the hydrophilicity thereof. Such conditions would also readily affect any carbon/organic material contained therein and their effect on the hydrophilicity. Therefore, since the range of hydrophilicity is dependent on factors outside of the claimed low organic/carbon atmosphere initially present at the time of packaging, the scope of the claim is rendered indefinite. Further, it is also unclear as to how hydrophilicity loss can be determined due the presence of carbon and/or organic material as other factors (i.e. temperature, humidity, etc.) would readily affect such hydrophilicity.
Regarding Claims 13-24 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 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 in further view of “Superhydrophilic (superwetting) surfaces” (NPL document, see attached PDF).
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);
displacing organic material (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); and
sealing the implant (10) in the sealable package to form at least a low organic atmosphere in the sealed 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),
wherein the low organic atmosphere 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; see 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; further note the 112(b) rejections above as other factors would readily affect such hydrophilicity).
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 displacing the organic material, (2) the sealing the implant in the package occurs within about 2 to 60 minutes after placing the medical implant in the sealable package.
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 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).
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 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).
Claims 15-16 and 21-24 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), as applied to Claims 12 and 14, and in further view of Guelzow (US PGPUB 2009/0200198).
Regarding Claims 15-16, Jin, as modified, discloses several features of the claimed invention but does not disclose an absorbent or adsorbent to actively attract and bind carbon gas present in the sealable package to reduce and/or eliminate carbon gas within the sealed package, and removing said absorbent or adsorbent before said sterilizing and providing a sealable package with a main compartment for holding the medical implant and a secondary compartment for holding the absorbent or adsorbent.
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 a 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 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.
Further, although Guelzow does not disclose removing the absorbent from the package prior to sterilizing the package, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have removed the absorber incorporated into Jin at the point of use and sterilize the package prior to removing the implant for use in order to readily ensure sterility of the implant at the point of use.
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 displacing 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 (Para. 0041).
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 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.
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) and “Superhydrophilic (superwetting) surfaces” (NPL document), 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.
Claims 19-20 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), as applied to Claim 12, and in further view of Tornier (US PGPUB 2004/0134821) and DelDuca (US Patent 5,811,142)
Regarding Claims 19-20, Jin, as modified, discloses several features of the claimed invention but does not disclose storing the sealed package (80) in a larger airtight container, wherein said storing the sealed package in a larger air tight container includes storing the sealed package in a larger air tight container with an absorbent or adsorbent contained therein, wherein the ambient atmosphere around the sealed package has an atmosphere with the organic material, such as carbon gas, removed.
First, attention can be brought to the teachings of Tornier which includes placing an implant (2; Figure 2) in a sealed package (8; Para 0038, 0041) and then storing the sealed package (8) in a larger airtight container (envelope 6; Figure 4), wherein the ambient atmosphere around the sealed package (8) has an atmosphere with the organic material, such as carbon gas, removed (see Para. 0044-0047 which discloses evacuating envelope 6, injecting inert gas, and sealing the envelope).
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 larger container to insert the sealed package therein in the manner as taught by Tornier to package the implant of Jin. By utilizing such a larger container, further protection of the implant can be obtained and a barrier gas preventing ambient air from reaching the implant as taught by Tornier (see Para. 0052) while also obtaining a long-term sterile environment for the implant as taught by Tornier (Para. 0007).
Further, although Tornier does not disclose utilizing an absorbent in the larger container, attention can be further brought to the teachings of DelDuca which includes placement of an absorbent (28; Figure 2) between an inner package (14) and an outer package (12; Col 4, lines 46-51).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have further incorporated an absorber in Jin between the inner package and larger outer container/package as taught by DelDuca. By incorporating an absorber into Jin, any remaining oxygen can be absorbed and therefore further protect the article (implant) from the ambient atmosphere as taught by DelDuca (Col 4, lines 52-66).
Allowable Subject Matter / Examiner’s Note
Claim 17 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.
Response to Arguments
Applicant's arguments filed 12/12/2025 with respect to the 112 rejections have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on Pages 12-13 pertaining to the 112(b) rejections, Examiner respectfully disagrees and reiterates that the recitations of “low organic or carbon atmosphere” does, in fact, render the claim indefinite. Applicant appears to attempt to define such an amount with the subsequent “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”. However, this does not readily provide a definite boundary of the term “low” as the “hydrophilicity” will readily vary based on factors outside of the initial carbon/organic levels. Therefore, such an additional limitation does not readily provide a clear scope as to what is “low organic or carbon atmosphere” and provides further indefiniteness of the claim.
Applicant’s arguments with respect to the prior art rejections of the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. see “Notice of References Cited”.
-Duthie (US Patent 5,547,635), Oral (US PGPUB 2018/0318468), Gingras (US PGPUB 2005/0234291), Simon (US PGPUB 2001/0039455) and Blay (US PGPUB 2023/0218373) each disclose a cleaning followed by packaging of an implant.
-Ehlbeck (US PGPUB 2017/0133205) discloses “Sterile packaging can immediately follow the completion of the respective decontamination, or respectively sterilization or cleaning process.” (Para. 0051).
-Lam (US PGPUB 2016/0302906) discloses sterilizing followed by sealing of an implant.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 1/14/2026