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 (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.
Claims 1-2, 4, 6-7, 13-15 and 22- 26 are rejected under 35 U.S.C. 103 as being unpatentable over Sievi et al. (WO2021/058154).
Regarding claim 1, Sievi teaches that it is known to form a coating of platinum metal on a substrate by coating the substrate with a platinum complex reading upon the noble metal ink claimed and heating the substrate to thereby form the layer (see last two paragraphs before the Examples section). Sievi fails to teach the specific percentage of the platinum complex present in the solvent of the ink. However, it should first be noted that the composition of Sievi is provided in a solvent that would be part of the “ink”. Further those of ordinary skill in the art would readily recognize that the amount of solvent employed would directly control the flowability and coatability of the coating composition. There is logically seemingly no need for solvent other than to disperse the coating provided, as it is seemingly removed by thermal treatment. Further, too much solvent would cause drying and coating times to become exhaustive in order to provide the same amount of coating material. Therefore those of ordinary skill in the art recognize a need to both provide at certain amount of solvent without over-providing it and the level should be optimized. Therefore, in the absence of criticality of the specific weight percentage claimed, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of solvent provided to the coating composition of Sievi (thereby also optimizing the weight of platinum present) in order to control the coatability and flowability of the coating composition of Sievi. Further Sievi teaches that the layers formed are “smooth”, “homogenous” and are compared to a “mirror”. One reading the teachings of Sievi would reasonably envisage the layers of Sievi to be “closed”, as claimed.
Regarding claim 2, Sievi teaches providing coating thicknesses in the claimed range (see paragraph before Examples section).
Regarding claim 4, the teachings of Sievi are as shown above. Sievi fails to explicitly teach the roughness claimed. However, Sievi explicitly teaches that his formed, desired product layers are “smooth”, “homogenous” and are compared to “mirror” finishes that are “non-grainy” and “flat”, “without desired interruptions” (see last paragraph before the Examples section). Surface roughness is literally a measure of smoothness and as such Sievi generally guides towards lower roughness levels of the coating and uniformity. Therefore, in the absence of criticality of the specific roughness range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the roughness of the coatings of Sievi in order to control the smoothness and homogeneity of the invention of Sievi.
Regarding claim 6, given that Sievi teaches the use of the same compositions claimed being coated and dried using the same techniques of the current specification and Sievi teaches coating thicknesses in the range claimed, it must be inherent that the coating density applied by Sievi would read upon the claimed range as well.
Regarding claim 7, the teachings of Sievi are as shown above. Sievi fails to explicitly teach a volume of coating applied. However, Sievi explicitly teaches coating thicknesses in the same range as those claimed herein. As such, for an identical substrate coated in the same pattern, the coating of Sievi would be volumetrically identical as well. Given that the substrate of the current claims is non-limiting nor is the general disclosure of Sievi, the current claims necessarily read upon coating some of the same substrates as Sievi with a possibly variation in pattern/shape of the coating being the difference. However, the Court has long held that in the absence of a new and unexpected result arising from a change in a prior art provided shape, a newly provided shape for a prior art element is not patentable over said prior art. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 13, Sievi teaches the production of products that read upon the current claims (see Example 1) wherein the disclosure of Sievi otherwise states that the compounds may also be C6-C18-type (see claim 1).
Regarding claim 14, Sievi further teaches wherein the compounds may comprise COD as L1L2 (see claim 5).
Regarding claim 15, the teachings of Sievi are as shown above. Sievi fails to teach the exact chemical compound claimed. However, Sievi does teach the use of (COD)Pt[O(CO)$]2 wherein $ may be C6-C18 as described above. The compound claimed is literally a C6-C18 compound that does read upon that grouping. However, the implied C6-C18 structure does not implicitly provide for the two (CH3) groups present in the claimed composition. Although they may be considered part of the a C6-C18 compound, without clarification, C6-C18 reasonably implies a linear C6-C18 compound as is part of the composition claimed in C6H13. However, the addition of two methyl groups to the carbon chain of Sievi herein should be considered an obvious variant of the composition of Sievi. The reactivity of the compounds of Sievi would not be expected to substantially change if the methyl groups were provided in a linear fashion or as side groups to a linear chain. The reactivity of additional carbon groups is generally indicated by Sievi with the statement that the compound may comprise combinations between 6 carbons and 18 carbons without a substantial change in effect of the product. The level of ordinary skill in the art in this area of expertise would be high but the level of predictability as indicated by Sievi’s claimed wide range would also be high. The number of compositions discussed above are only a super-minority portion of the compositions listed by Sievi as functional for his intended purposes. Further given that Sievi specifically provides the grouping “C6-C18” Sievi effectively has provided a limited number of possible variations of the arrangement of carbons that one of ordinary skill in the art would reasonably envisage. Further, for example, the addition of carbon in a non-linear fashion changes butane to iso-butane but both compounds are chemically very similar and useful for the same purposes. In general, the addition of methyl side groups to linear carbon chains is known in the prior art to not substantially effect the reactivity of compositions provided and methyl groups are among the least reactive chemical groups provided. Therefore based on the provided teachings of Sievi and the knowledge of those of ordinary skill in the art, the compound claimed in claim 15 should be considered an obvious chemical variant of those described by Sievi. See MPEP 2144.08.
Regarding claim 22, the “completely closed” layer of Sievi would be expected to contain no cracks of any size.
Regarding claims 23-25, it is first noted that the current claim does not include an active step. This is to say that the claim defines what “can be” done or what is capable of being done but it does not require actually testing in any manner. Furthermore, the surface being completely closed should be reasonably able to be verified in the invention of Sievi in any way that it could be verified in the current application.
Regarding claim 26, it is noted that “hermetic” as claimed herein is synonymous with airtight wherein the platinum complex film of Sievi would presumably be as capable of hermetic sealing as the currently claimed film due to its completely closed nature.
Claims 1, 5, 8-12, 16 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (USPGPub 2004/0043052) in view of Sievi et al. (WO2021/058154).
Regarding claims 1, 8-12 and 16, Hunter teaches providing a medical device such as a stent [0096], which made be made from stainless or plastic [0198] with a coating by dip coating among other techniques (see Examples) that may read upon a noble metal platinum complex containing ink (see abstract)[0076] wherein thereafter the coating applied is heated by vacuum drying to yield a layer of the platinum complex on the surface of the medical device (see Examples). Further it is noted that Hunter teaches the use of concentrations of the active compounds (abstract) used in his examples if replaced with the platinum complex cisplatin also cited from the abstract as useful for the same purpose would read upon the claimed percentages especially wherein, for example, in Example 3 2000mg of PLG is mixed with 20mg of mitoxantrone (100:1 ratio). If cisplatin were used in place of mitoxantrone in the same ratio that would yield a composition of roughly 0.65% platinum. However, this specific combination was not provided. However, Hunter goes on to state that concentrations of these compounds are known to be varied, wherein the amount of each present directly controls the antibiotic affect of the provided coating [0332]. Therefore while it can be stated that Hunter would seemingly generally uses his drugs in concentrations reading upon the current claims, it can further be stated that in the absence of criticality of the specific mass percentage of the current claims it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration of active agents in the coating of Hunter in order to optimize the antibacterial activity of the coatings composition of Hunter. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215. Hunter fails to teach wherein the layer would be assumed to be “completely closed”. However, Sievi teaches that it is known to provide platinum complex layers for medical devices in a manner such that his formed, desired product layers are “smooth”, “homogenous” and are compared to “mirror” finishes that are “non-grainy” and “flat”, “without desired interruptions” (see last paragraph before the Examples section), wherein it is the interpretation of the examiner that this would read upon the phrase “completely closed”. Those of ordinary skill in the art would readily recognize that smooth, defect free layers would provide both mechanical durability as well as prevent the presence of cracks and ingress areas for the formation of cellular growth from both the human body and bacteria in vivo. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the coatings of Hunter in a “completely closed” manner as guided by Hunter in order to provide the benefits associated with “completely closed” surfaces known to those of ordinary skill in the art as described above.
Regarding claim 5, Hunter does not require the use of material in his coating and in particular the components provided are present in solvents to presumably dissolve particulates.
Regarding claim 22, the “completely closed” layer of Hunter in view of Sievi would be expected to contain no cracks of any size.
Regarding claims 23-25, it is first noted that the current claim does not include an active step. This is to say that the claim defines what “can be” done or what is capable of being done but it does not require actually testing in any manner. Furthermore, the surface being completely closed should be reasonably able to be verified in the invention of Hunter in view of Sievi in any way that it could be verified in the current application.
Regarding claim 26, it is noted that “hermetic” as claimed herein is synonymous with airtight wherein the platinum complex film of Hunter in view of Sievi would presumably be as capable of hermetic sealing as the currently claimed film due to its completely closed nature.
Response to Arguments
Before examining the applicants’ arguments, it should be noted that the applicants arguments revolve largely around the use of the term “completely closed”. It is noted that this term is not defined in he current specification. However, in art in the field a “closed” structure is generally one referred to as a structure that does not have pores open to the surface, hence the term “open” porosity and “closed” porosity. The term “completely closed” was generally regarded as such herein.
The applicant first argues that one of ordinary skill in the art would not optimize the coating of Sievi in order to obtain a completely closed layer. However, Court has long held that the prior art modification need not be performed for the same reason as the currently claimed invention. “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). Further the applicant questions what qualities of coatability and flowability and how they are applicable. First it is noted that both “coatability” and “flowability” terms used in domestic and international disclosures literally hundreds of thousands of times excluding their mention in non-patent literature. These terms are well understood by those of ordinary skill in the art. However, to provide at least some clarity as relates to the prior art provided, “coatability” simply refers to the ability to form a desired coating with the material. It hinges on a variety of factors that are readily modified by those of ordinary skill in the art in order to provide desired coating thicknesses especially in timeframes that are industrially efficient. If a composition is too thin (i.e., contains too much solvent) it may have a tendency to run off of a surface that it is intended to coat and not provide coatability. Further a composition may have undesired flow properties for a host of reasons including high solute content, low solvent content, poor solvent combination, the presence of particulates and etc. If a coating does not flow well on its own it may require addition means to spread the coating such as brushing or heat or a host of possibilities otherwise. As such, flowability, measured by viscosity, is incredibly well understood in the coating arts and relates directly to coatability. However, for example a hydrophobic coating material may be provided to a hydrophilic coating surfaces and may be highly flowable but not highly coatable. As such, the terms have some overlap in scope but are not identical in meaning. Further the applicant argues that the rejection does not establish that coatability and flowability modification would necessarily lead to a completely closed layer. However, as stated above, the rejection states what steps that one might take to optimize that would read upon the range claimed. It is the applicants themselves that establish that the provision of a specific ratio of noble metal used leads to a completely closed layer. However, it appears as thought the applicant has merely noticed a quality not mentioned in the prior art that occurs within a given range over which the prior art might optimize. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Further the applicant argues that the layer of Sievi would not be considered “completely closed” even though it is literally described as “smooth”, “homogenous”, “mirror-like”, “non-granular” and “without… interruptions”. There is no mention of cracking at any scale of defects. The applicant argues that this “does not necessarily form a noble metal layer that is closed”. However it remains the position of the examiner that a lack of teaching of porosity as well as the prior art using the same terminology employed by the current application including terms such as “smooth” wherein the inclusion of porosity seems to be indicative of an open structure as is generally referred to in the field would indicate that the layer of Sieve is in fact closed in the same manner claimed.
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Further the applicant argues that the range of 5% or less noble metal is critical. However, the applicant has not reasonably established criticality. First the dipping procedure for ink A in Example 10 and ink B is varied in the number of times. It cannot be stated that this is not a factor in the variation provided. Second, testing exactly 5% does not establish any criticality to 5%. It clearly indicates that 5% is functional but is does not indicate anything that happens below 5% which is within the range claimed. Additionally, showing that 10% is not functional especially with a varied dipping procedure may begin to support the criticality of less than 10% but the variation along with few data points is not reasonably sufficient to establish the percentage of noble metal as a critical element in the formation of “completely closed” structures.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah-Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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