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 .
Information Disclosure Statement
The information disclosure statement filed 9/11/24 and 5/27/25 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
The FOR documents are not in English.
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 1-11 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.
Claim 1 recites an inert silicon-based coating. The claim does not specify to what the coating is considered inert. The coating could be inert to a particular solution but not inert to another solution. Therefore, the metes and bounds of the claim would depend on an unspecified element not defined by the claim and are indefinite. For examination purposes the coating is assumed to be inert to the sample.
Claim 2 recites the sample is sensitive to metals. The term “sensitive” is unclear as one of ordinary skill in the art would not immediately understand what property the sample would have to be considered “sensitive”. The term is not defined by the specification nor is it an art recognized term that would have been immediately understood by one of ordinary skill in the art.
The additional claims are rejected as depending from claim 1.
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) 1, 3-9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Good US 3,808,125.
Claim 1, Good teaches a method of determining sample contamination comprising: providing a liquid chromatography system having at least one metal containing passageway (11) comprising an interior surface (12) coated with a silicon-based coating (14, 13) (fig. 2, col. 1, lines 67-70, col. 4, lines 21-39), directing a sample through the coated metal containing passageway and measuring an amount of the sample remaining after passing through the coated metal containing passageway (col. 1, line 44 – col. 2, line 46). Good does not teach the coating reacting with the sample and therefore the coating is taken as being inert with respect to the sample.
Claims 3-9 and 11, Good further teaches the coating comprising a SiOxCy species (col. 10); the coating has a uniform composition along a length of the coated passageway (col. 2, lines 47-60); the coating is an amorphous array of Si-C bonds (col. 10, lines 39-52); the coating comprises two layers each comprising different silicon based species (col. 10); and the metal containing passageway comprises a column (col.
4, lines 21-39).
Claim(s) 1-7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belov et al. US 2011/0263838.
Claim 1, Belov teaches a method of determining sample contamination comprising: providing a liquid chromatography system having at least one metal containing passageway (12) (par 49) comprising an interior surface coated with an inert silicon-based coating (18) (fig. 1-2, par 32, 36, 103-104), directing a sample through the coated metal containing passageway and measuring an amount of the sample remaining after passing through the coated metal containing passageway (par 93-94).
Claims 2-7 and 11, Belov further teaches the sample includes biological elements, which, as stated by applicant in the background section of the specification, are sensitive to leaching of metal ions or interacting with metal surfaces (par 15); the inert coating includes siloxane and organosilicone (par 42); the coating is uniform along a length of the coated passageway (par 32-39); the coating would include an amorphous array of Si-C bonds (par 42); and the metal containing passageway comprises a column (fig. 1-2).
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.
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Good US 3,808,125.
Good teaches the method of claim 1 but does not teach the specific thickness of the coating. Good recognizes the thickness of the coating as a result effective variable as a uniform and an optimum thickness is desirable as too much coating and column efficiency is affected and too little coating column capacity and efficiency are affected (col. 2, lines 25-35). Good also teaches the coating process is adjusted to achieve the desired thickness (col. 11, lines 50-65). The recites thickness is an optimization of the thickness of the coating to achieve a desired result. Good teaches the thickness should be adjusted and provides a mechanism by which the thickness may be adjusted. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller, 105 USPQ 233 (1955).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belov et al. US 2011/0263838.
Belov further teaches the coating having a thickness but does not teach the specific dimensions of the thickness. Belov teaches the thickness of the coating is correlated to the radius of the tube to optimize efficiency of the device (par 32). The recites thickness is an optimization of the thickness of the coating to achieve a desired result. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller, 105 USPQ 233 (1955).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belov et al. US 2011/0263838 in view of Good US 3,808,125.
Belov teaches a layer of a silicon based species but does not teach two or more layers.
Good teaches the coating comprises two layers each comprising different silicon based species (col. 10). It would have been obvious to one of ordinary skill in the art to use the multiple layers of Good as the two layers with different silicon species allows one layer to bond to the column and the other layer to bond to the second layer (col. 3, lines 1-30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN M KURTZ whose telephone number is (571)272-8211. The examiner can normally be reached Monday-Friday 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at 571-270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN M KURTZ/Primary Examiner, Art Unit 1779
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