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 listing of references in the specification is not a proper information disclosure statement (e.g., specification, paragraph 3). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-17 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claims 16 and 17 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 16 and 17 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 pre-AIA the applicant regards as the invention.
Claim 16 provides for the use of the standard product for measuring hepcidin according to claim 13, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 17 provides for the use of the reagent for measuring hepcidin according to claim 114, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 6, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Vaulont et al. (US 2010/0285027 A1; hereinafter “Vaulont”).
Regarding claim 1, Vaulont teaches a hepcidin adsorption inhibitor comprising a chelating agent (e.g., Ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraph 93).
Regarding claim 2, Vaulont teaches the hepcidin adsorption inhibitor according to claim 1, wherein the chelating agent is an aminocarboxylic acid-based chelating agent or a phosphonic acid-based chelating agent (e.g., ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraph 93).
Regarding claims 3 – 6, these claims are considered to be statements of intended use for the claimed chelating agent material composition. Since the prior art teaches the same composition as claimed (EDTA in this case as indicated above), absent any other evidence to the contrary, the composition is presumed to have the same material or chemical properties as claimed. Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). Furthermore, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.).
Regarding claim 13, Vaulont teaches a standard product composition capable of being used for measuring hepcidin, comprising: the hepcidin adsorption inhibitor (EDTA) according to claim 1; and hepcidin (hepcidin solution comprising the hepcidin and running buffer comprising 3 mM EDTA; paragraph 93). The recitation that the standard product is for measuring hepcidin is considered a statement of intended use and is afforded no patentable weight. Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). Furthermore, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.).
Regarding claim 14, Vaulont teaches a reagent composition capable for measuring hepcidin, comprising: the hepcidin adsorption inhibitor (EDTA) according to claim 1 (Ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraph 93). The recitation that the reagent is for measuring hepcidin is considered a statement of intended use and is afforded no patentable weight. Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). Furthermore, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.).
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.
Claim(s) 7, 8, 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaulont et al. (US 2010/0285027 A1; hereinafter “Vaulont”) in view of Watt et al. (US 2003/0215846 A1; hereinafter “Watt”) and Stewart et al. (US 2010/0248389 A1; hereinafter “Stewart”).
Regarding claim 7, Vaulont teaches a method of inhibiting adsorption of hepcidin, comprising: bringing a hepcidin-containing liquid into contact with a member comprising a BIAcore SPR chip surface in the presence of a chelating agent (e.g., ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraphs 92 and 93).
Vaulont does not specifically teach that the member is a glass member.
However, Watt teaches that BIAcore sensor chips comprise a glass surface (paragraph 344).
Furthermore, Stewart teaches that EDTA is a well known chelating agent for inhibiting protein adsorption onto surfaces (paragraph 73).
The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a method of inhibiting adsorption of hepcidin, comprising: bringing a hepcidin-containing liquid into contact with a member comprising a glass member, such as a BIAcore SPR chip surface, which is comprised of glass (Watt; paragraph 344), in the presence of a chelating agent known for inhibiting protein adsorption (Vaulont: ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraphs 92 and 93; Stewart: paragraph 73).
Regarding claim 8, Vaulont teaches the method of inhibiting adsorption of hepcidin according to claim 7, wherein the chelating agent is an aminocarboxylic acid-based chelating agent or a phosphonic acid-based chelating agent (e.g., ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraphs 92 and 93).
Regarding claim 12, Watt teaches wherein the member is glass member (Watt teaches that BIAcore sensor chips comprise a glass surface; paragraph 344).
Regarding claim 15, Vaulont teaches a reagent kit capable for measuring hepcidin, wherein the hepcidin adsorption inhibitor according to claim 1 includes a hepcidin adsorption inhibitor (e.g., ethylenediaminetetraacetic acid (EDTA), which is a known chelating agent; Example 3; paragraph 93) that is accommodated in a measuring instrument (a BIAcore sensor chip; paragraphs 91 – 93), but does not teach that the measuring instrument has at least one member selected from a rubber member, a plastic member, or a glass member.
Watt teaches that BIAcore sensor chips comprise a glass surface (paragraph 344). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a measuring instrument such as a BIAcore sensor chip having a glass member or a glass sensor surface.
Claim(s) 9 – 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaulont et al. (US 2010/0285027 A1; hereinafter “Vaulont”), Watt et al. (US 2003/0215846 A1; hereinafter “Watt”) and Stewart et al. (US 2010/0248389 A1; hereinafter “Stewart”), and further in view of Arbogast et al. (US 2004/0018974 A1; hereinafter “Arbogast”).
Regarding claim 9, Vaulont does not specifically teach the method of inhibiting adsorption of hepcidin according to claim 7, wherein the member is a rubber member.
However, Arbogast teaches that containers used in chemical manipulations can have stoppers made of a synthetic rubber material comprising butyl rubber (paragraph 236). It would be logical and quite expected that a person of ordinary skill in the art performing the method of Example 3 of Vaulont would be utilizing various containers having stoppers comprised of butyl rubber, which are well known in the art as evidenced by Arbogast, for containing and manipulating the various solutions used. The further use of EDTA to prevent or inhibit the adsorption of hepcidin to the rubber stopper would also have been considered to be suitable and predictable to a person of ordinary skill in the art, so that no hepcidin is lost and wasted. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. Therefore, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to provide wherein the member is a rubber member.
Regarding claims 10 and 11, Arbogast teaches wherein the rubber member is a synthetic rubber member comprising butyl rubber (paragraph 236).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796