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 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 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.
Claims 1-2, 5-9, 12-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (USPGPub 2008/0181861) in view of Chilkoti et al. (USPGPub 2006/0057180) and Zhang et al. (“Porous Gold Films-A Short Review in Recent Progress”, Materials, 05-2014, Vol. 7, No. 5, pp. 3834-3854) and Malak (USPGPub 2005/0164169).
Regarding claims 1-2, 5, 7-9 and 21, Jiang teaches that it is known to provide a gold substrate with a self-assembled monolayer formed thereon from a combination of bromoisobutyryl bromide and mercaptoundecanol [0116] (also used in the current specification) to form a coupling agent having a first end bonded to the metal substrate and the other end to a polycarboxybetaine (zwitterionic) polymer through a reaction for the purposes of providing an anti-fouling coating. Jiang fails to teach wherein the substrate is porous. However, Chilkoti teaches that when using the same components listed above to form a monolayer to coat a gold substrate [0078-0079] for further attachment of an additional polymer, it is known to use both porous and nonporous substrates [0034]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the porous substrates of Chilkoti in the invention of Jiang as a simple substitution of one known gold substrate structure for another in a polymeric coating method wherein the results would be predictable based on the disclosure of Chilkoti. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396. The teachings of Jiang in view of Chilkoti are as shown above. Jiang in view of Chilkoti is silent as to the size of the pores of the porous gold substrates employed. However, Zhang teaches that the pore size of porous gold films directly affects the surfaces area of those films wherein said surface area directly affects the level of protein adsorption of said substrates (see Section 5.1.2.) and wherein Zhang teaches the use of pore sizes in the rang claimed (see section 4.3). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the pore size of Zhang for the pore of the gold substrates of Jiang in view of Chilkoti in order to control the adsorption level of said substrates as guided by Zhang. The teachings of Jiang in view of Chilkoti and Zhang are as shown above. Jiang in view of Chilkoti and Zhang fails to teach that the pores form a “porous percolating pathway”. While a “porous percolating pathway” is not truly defined in the current specification, the limitation that is seemingly described would amount to what is known in the prior art as “open porosity”, which constitutes connected pores instead of isolated pores, thereby allowing the movement of fluid through the porosity. As acknowledged by the applicant, the prior art does not provide examples and therefore it is unclear as to whether the porosity provided is open or closed cell. However, given a limited number of possibilities (i.e., open cell, closed cell or a combination of both), it would have been considered “obvious to try” for one of ordinary skill in the art before the effective filing date of the claimed invention to choose any of the three known possibilities provided wherein all would predictably function in the invention of Jian in view of Chilkoti and Zhang with a reasonable expectation of success. The teachings of Jiang in view of Chilkoti and Zhang are as shown above. Jiang in view of Chilkoti and Zhang fails to teach wherein the metal is among those claimed for the porous substrate although, it is noted that Jiang reasonably implies that the reasoning for choosing gold in particular in his invention is because of it is surface plasmon activity thereby allowing the material to be formed into a surface plasmon active sensor [0171-0173]. Those of ordinary skill in the art would also acknowledge that gold is generally considered to be non-toxic and biologically tolerated. However, Malak teaches that for the formation of medical devices wherein the generation of surface plasmon resonance [0062] it is known to use metals such as gold or zinc that are surface plasmon active (claim 5). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the gold of Jiang in view of Chilkoti and Zhang with the zinc of Malak as simple substitution of one known surface plasmon active metal used in the manufacture of surfaces medical implants wherein the results of the substitution would have been predictable based upon the teachings of Malak that both metals are known to be used for the stated similar purposes.
Regarding claim 6, the teachings of Jiang in view of Chilkoti, Zhang and Malak are as shown above. Jiang in view of Chilkoti, Zhang and Malak fails to teach wherein the metal is among the oxides listed. However, it is noted that Malak does teach the use of a number of metals as well as those same metals in conjunction with their oxides (claim 5) and Malak teaches the use of metal oxides in general (claim 4). Given that Malak teaches the use of rhodium as the substrate metal and metal oxides in general and metal oxides of some of the other metals listed in claim 5 in addition to rhodium, it is the position of the examiner that one of ordinary skill in the art would reasonably and immediately envisage the use of rhodium oxide in addition to rhodium metal based upon the collective teachings of Malak.
Regarding claims 12-13, Jiang further teaches the use of the coatings in drug delivery devices and/or implantable devices [0134].
Regarding claims 19, Jiang teaches that it is known to provide a gold substrate with a self-assembled monolayer formed thereon from a combination of bromoisobutyryl bromide and mercaptoundecanol [0116] (also used in the current specification) to form a coupling agent having a first end bonded to the metal substrate and the other end to a polycarboxybetaine (zwitterionic) polymer through a reaction for the purposes of providing an anti-fouling coating. Jiang fails to teach wherein the substrate is porous. However, Chilkoti teaches that when using the same components listed above to form a monolayer to coat a gold substrate [0078-0079] for further attachment of an additional polymer, it is known to use both porous and nonporous substrates [0034]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the porous substrates of Chilkoti in the invention of Jiang as a simple substitution of one known gold substrate structure for another in a polymeric coating method wherein the results would be predictable based on the disclosure of Chilkoti. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396. The teachings of Jiang in view of Chilkoti are as shown above. Jiang in view of Chilkoti fails to wherein the metal is among those listed. However, Jiang does explicitly states that metal among a large number of other surface types are suitable for treatment by his method. Further given that the invention of Jiang is related to implantable medical devices, the list of possible metals considered useful would be limited to those that are suitable for implantation into the human body and reasonably one of ordinary skill in the art would be drawn to those metal that are commonly provided in medical implants. Further the examiner it is taking Official Notice to inform the applicant that nitinol (an alloy of titanium) and stainless steel are highly common medical implants metals for the surface of substrates as well as gold and the three are known to be used interchangeably. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the gold layer of Jiang in view of Chilkoti with stainless steel or nitinol as are known in the art as simple substitution of one known biomedical implant metal for another wherein the substitution would be considered obvious based on the known substitutability of those materials in the prior art. The teachings of Jiang in view of Chilkoti are as shown above. Jiang in view of Chilkoti is silent as to the size of the pores of the porous gold substrates employed. However, Zhang teaches that the pore size of porous gold films directly affects the surfaces area of those films wherein said surface area directly affects the level of protein adsorption of said substrates (see Section 5.1.2.) and wherein Zhang teaches the use of pore sizes in the rang claimed (see section 4.3). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the pore size of Zhang for the pore of the gold substrates of Jiang in view of Chilkoti in order to control the adsorption level of said substrates as guided by Zhang. The teachings of Jiang in view of Chilkoti and Zhang are as shown above. Jiang in view of Chilkoti and Zhang fails to teach that the pores form a “porous percolating pathway”. While a “porous percolating pathway” is not truly defined in the current specification, the limitation that is seemingly described would amount to what is known in the prior art as “open porosity”, which constitutes connected pores instead of isolated pores, thereby allowing the movement of fluid through the porosity. As acknowledged by the applicant, the prior art does not provide examples and therefore it is unclear as to whether the porosity provided is open or closed cell. However, given a limited number of possibilities (i.e., open cell, closed cell or a combination of both), it would have been considered “obvious to try” for one of ordinary skill in the art before the effective filing date of the claimed invention to choose any of the three known possibilities provided wherein all would predictably function in the invention of Jian in view of Chilkoti and Zhang with a reasonable expectation of success.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (USPGPub 2008/0181861) in view of Chilkoti et al. (USPGPub 2006/0057180), Zhang et al. (“Porous Gold Films-A Short Review in Recent Progress”, Materials, 05-2014, Vol. 7, No. 5, pp. 3834-3854) and Malak (USPGPub 2005/0164169) as applied to claims 1-2, 5-9, 12-15 and 19-21 above and further in view of Vena et al. (WO2019/237093).
Regarding claims 10-11, the teachings of Jiang in view of Chilkoti are as shown above. Jiang in view of Chilkoti fails to teach wherein the zwitterionic polymer provided is polytrimethylamine n-oxide. However, Vena teaches that trimethylamine n-oxide groups are known alternatives to carboxybetaine groups for the formation of non-fouling coatings. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the polycarboxybetaine of Jiang in view of Chilkoti with the polytrimethylamine n-oxide of Vena as a simple substitution of one known zwitterionic anti-fouling polymer for another to obtain predictable results.
Claims 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (USPGPub 2008/0181861) in view of Chilkoti et al. (USPGPub 2006/0057180) and Malak (USPGPub 2005/0164169).
Regarding claims 22-23, Jiang teaches that it is known to provide a gold substrate with a self-assembled monolayer formed thereon from a combination of bromoisobutyryl bromide and mercaptoundecanol [0116] (also used in the current specification) to form a coupling agent having a first end bonded to the metal substrate and the other end to a polycarboxybetaine (zwitterionic) polymer through a reaction for the purposes of providing an anti-fouling coating. Jiang fails to teach wherein the substrate is porous. However, Chilkoti teaches that when using the same components listed above to form a monolayer to coat a gold substrate [0078-0079] for further attachment of an additional polymer, it is known to use both porous and nonporous substrates [0034]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the porous substrates of Chilkoti in the invention of Jiang as a simple substitution of one known gold substrate structure for another in a polymeric coating method wherein the results would be predictable based on the disclosure of Chilkoti. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396. The teachings of Jiang in view of Chilkoti are as shown above. Jiang in view of Chilkoti fails to teach wherein the metal is among those claimed for the substrate although, it is noted that Jiang reasonably implies that the reasoning for choosing gold in particular in his invention is because of it is surface plasmon activity thereby allowing the material to be formed into a surface plasmon active sensor [0171-0173]. Those of ordinary skill in the art would also acknowledge that gold is generally considered to be non-toxic and biologically tolerated. However, Malak teaches that for the formation of medical devices wherein the generation of surface plasmon resonance [0062] it is known to use metals such as gold or zinc that are surface plasmon active (claim 5). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the gold of Jiang in view of Chilkoti with the zinc of Malak as simple substitution of one known surface plasmon active metal used in the manufacture of surfaces medical implants wherein the results of the substitution would have been predictable based upon the teachings of Malak that both metals are known to be used for the stated similar purposes.
Regarding claim 24, Jiang further teaches wherein the implant is an in vivo sensor [0134] wherein it is reasonably implicit that this may be a blood contacting sensor in at least some applications because Jiang teaches that blood compatibility is a substantial consideration in his field of endeavor. Further given a limited number of possibilities wherein the sensors of Jiang are either blood-contacting or non-blood contacting it would have been “obvious to try” for one of ordinary skill in the art before the effective filing date of the claimed invention to form either type of sensor in the invention of Jiang in view of Chilkoti wherein both solutions would be predictably formed and employed with a reasonable expectation of success.
Regarding claims 25-26, Jiang further teaches the use of the coatings in drug delivery devices and/or implantable devices [0134].
Response to Arguments
The applicants arguments are generally moot in view of new grounds of rejection based entirely on the provision of newly provided prior art based on the amendment of the previously provided claims.
Conclusion
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
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