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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “measurement flow channel” and “supply device” in claims 1, 6 and 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Arguments traversing the above interpretation are not persuasive. The explanations in the argument only confirms the office’s position, which is, the stated interpretation would read on what applicant disclosed as the structure of the part, plus equivalents thereof. If applicant desires to further limit the interpretation, the office suggests to add on any such limiting structural elements to these claim limitations.
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.
Claims 1-7 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.
Claims recite a “to contact at least part of an inner surface of the measurement flow channel.” Measurement flow channels are identified as items 40 and 50 in the figure connected to the upstream and downstream ends of the column 20, respectively. The disclosure only states that the conditioning liquid is passed through 40 and 50, and also the optical cell 73. This is confirmed by applicant’s argument of 8/18/26, under the ”Interpretation under 35 USC 112(f):” However, the figure shows that the conditioning liquid has to pass through the column if pumped through the conditioning supply 90. It is also unclear what happens when the conditioning liquid containing BSA is pumped through the column containing chromatographic packing material, especially when the purpose of BSA is to prevent hemoglobin from metal surfaces. The questions unaddressed are, would the BSA get adsorbed on to the packing material, and would that cause the hemoglobin from interacting with the packing material, if BSA is pumped through the packing material in column 20. Therefore, the claims are indefinite because it is unclear if the column packing is exposed to the conditioning liquid or not, and if not, how it is circumvented.
Also unclear is how (or the intent of how) the bovine serum albumin can be made to contact “… part of an inner surface” of the measurement flow channel. The specification does not seem to provide any details on how this “at least part of …” is accomplished.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation of “at least part of an inner surface” of the measurement flow channel appears to be new matter since the specification does not provide any details or clarification of what entails the “at least part of the …. channel.”
Claim Rejections - 35 USC § 102 and 103
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.
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 6-7 are rejected under 35 U.S.C. 102(a1) and anticipated by Setoguchi et al (US 6,428,704).
Claims 1-4 are rejected under 35 USC 103 as unpatentable over Setoguchi et al (US 6,428,704) in view of Mozaffar et al (US 6096870)
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The figure 16 of Setoguchi copied herein shows column eluents feed A-D with valves 2, pump 2, sample injector 3, col. 4 and analyzer integrator 5/6. This anticipates claims 6 and 7.
Subjecting the channels to conditioning liquid is a process issue, or materials worked upon, or an intended use of the apparatus which does not further limit the apparatus claims.
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)
Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
However, Setoguchi does teach conditioning of the system as well as a supply device for it, as in the process claims 1-4 in a method for determining hemoglobin using liquid chromatography (abstract.) See blocking agents including albumin (BSA,) casein, etc., and the purpose in col. 17, line 64 to col. 18, line 5. The blocking agent prevents the components of the apparatus from absorbing the analytes. Supply of the conditioning or blocking agent can be through one of the eluent feeds, which is implied.
"[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968)
Hemoglobin A0 and A2: see fig. 23 – showing the peaks of these.
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While Setoguchi is silent on using hypochlorous acid (or bleach or equivalents) in cleaning the apparatus prior to use, such cleaning is well-known and commonly practiced on devices before and after handling protein or other biological solutions. See for example, Mozaffar. See col. 14, lines 34-44. Selecting the optimal chemical cleaner like hypochlorous acid is within the ability of one of ordinary skill. The actual concentration of BSA used is in a wide range, which can be optimized to afford the best results.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Response to Arguments
Applicant's arguments filed 8/18/26 have been fully considered but they are not persuasive.
Arguments against the rejection of claims 6 and 7 are not persuasive. Applicant appears to be arguing about some unexpected results, citing fig. 10 of the specification. While the data after cleaning can be considered as showing varying degrees of improvement with the various conditioning liquids, the difference between before cleaning and BSA after cleaning does not appear to be significant. In addition, to consider any unexpected results, all the elements that contributed to the unexpected results must be present in the claim.
Consideration of rebuttal evidence and arguments requires Office personnel to weigh the proffered evidence and arguments. Id.; see also In re Alton, 76 F.3d 1168, 1174-75, 37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996). Office personnel should avoid giving no weight to evidence submitted by applicant, except in rare circumstances. However, to be entitled to substantial weight, the applicant should establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective evidence of nonobviousness must be attributable to the claimed invention.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant submitted several references along with EU office action which anticipates of makes obvious all the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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, Prem Singh can be reached at 5712720579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
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