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 .
DETAILED ACTION
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.
Response to Restriction/Election
Applicant’s election of without traverse of Group I, claims 1 and 4, in response to restriction requirement is acknowledged. Applicant’s election of a specific combination of mannitol, trehalose, casein, a surfactant, gelatin, a preservative, and a buffer solution TBS and a mixture of sodium thiosulfate and EDTA-2N recited in claim 4, for antioxidant, is also acknowledged.
Applicant’s traversal is on the ground that amended claim 1 patently defines over the cited art because D1 fails to disclosed the technical feature of the amended claim 1 and thus Group I-IV have the same corresponding special feature and thus should be rejoined.
The above arguments have fully been considered but are not found persuasive because as described in the rejection below, the special technical feature of amended claim 1 is obvious in view of ? and ? and thus the groups of invention (I-IV) lack the same corresponding special technical feature as they do not have a common special feature that makes a contribution over the prior art. Therefore, the restriction/election requirement is still deemed valid and is made FINAL.
Therefore, claims 5-11 are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1 and 4 are examined on merits in this office action.
Claim Objections
Claim 1 recites “A freeze-dried preparation of chemiluminescent immune microsphere, wherein composed of one of more spherical solid particles having the same composition, comprising a reagent storage agent, a magnetic particles containing …..”, which is grammatically incorrect. Applicant is advised to revise the claim for clarity. For example, the claim may be amended to recite: “A freeze-dried preparation of chemiluminescent immune microsphere, the freeze-dried preparation comprising one of more spherical solid particles having the same composition, wherein the composition comprising: a reagent storage agent, a magnetic particles containing …. .
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 and 4 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 “the acridinium ester marking raw material is an antibody or an antigen marked by an acridinium ester”. The term “marked” is vague and the term has not clearly not been defined in the specification and it is not clear what is intended to encompass by the phrase “marked by an acridinium ester”. It the term intended to mean the antibody or antigen conjugated or labeled with the acridinium ester. If so, Applicant is advised to amend the claim to particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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 of this title, 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 1 and 4 are rejected under 35 U.S.C. 103 as obvious over Li et al. (CN 111965344A; IDS of 10/13/2022) in view of Yoshiaki et al (JP 2008239512), Coffman (2020/0253875A1; IDS of 10/13/2022) and Bao-feng et al (CN 104721152A).
In regards to claims 1 and 4, Li discloses a freeze-dried magnetic microparticle chemiluminescence immunoassay kit, which is a vacuum reagent tube, wherein the contents in the tube are two freeze-dried small microspheres, a freeze-dried magnetic microparticle coupled antibody or antigen, and an acridinium ester labeled antibody or antigen; microsphere A is composed of a superparamagnetic microsphere coupled antigen or antibody and a freeze-drying liquid, and microsphere B is composed of a label coupled antigen or antibody and a freeze-drying liquid; and the freeze-drying liquid is a Tris buffer containing a freeze-drying excipient and 0.2-1% bovine serum albumin, and the freeze-drying excipient is one or more of sucrose, glucose and trehalose (Li, claims 1 and 6-8). The freeze-drying liquid in Li is equivalent to a reagent storage agent, and the freeze-drying excipient corresponds to a lyoprotectant. Li also teaches storage solution (20 mM of Tris, 0.1 % of Tween, 0.5 % of bovine serum albumin.
Li discloses freeze-drying composition comprising Tris buffer, sucrose, glucose and trehalose protectant but however, does not disclose freeze drying composition also comprising, mannitol, casein, gelatin, PEG2000, antioxidant and a surfactant.
Yoshiaki is directed to antibody stabilizing method (Title). Yoshiaki teaches freeze-drying composition comprises sugar such as glucose and trehalose, sugar alcohols such as mannitol, proteins such as gelatin, casein and albumin, surfactants such as alkyl ether (paragraph [0024]). Yoshiaki further teaches various buffers including tris buffers having sodium chloride and having surfactants such as glycerol and ethylene glycol (para [0023]).
Coffman discloses a method for forming particles containing a diagnostic agent, which method comprises: forming droplets of a first liquid including an agent, removing the first liquid from a second liquid, solidifying the droplets to form particles, and carrying out freeze-drying on the particles after separating from the second liquid, wherein the particles may be stored for long periods of time without a loss of activity, and may be used to generate stabilized pharmaceutical compositions; the diagnostic reagent can be a protein, a magnetic particle, etc.; and the first liquid contains a protein stabilizer, an antioxidant, a protein, a preservative, etc., and the protein stabilizer can be PEG 20000 (see Coffman, description, paragraphs [0069] - [0071], [0111] and [0148]).
Bio-feng is directed to freeze-dried composition and teaches that common freeze-drying stabilizer includes sodium citrate, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, EDTA and the like (para [0067]).
Therefore, from the description in mind of Li and Yoshiaki, it would be obvious to one of ordinary skilled in the art to envisage including freeze-dying composition such as mannitol, gelatin, casein and TRIS-buffer in the Freeze-drying composition of Li because Yoshiaki teaches the components as known and commonly used freeze-dying composition. One of ordinary skilled in the art from the disclosure of Coffman and Boa-feng, would be motivated to further add PEG 20000 and an antioxidant such sodium thiosulfate, EDTA and/or vitamin C in the composition of freeze-dried antibody containing particles of Li because Coffman teaches that trehalose and PEG20000 are protein stabilized and Bo-feng teaches common freeze-drying stabilizer includes sodium citrate, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, EDTA and the like (para [0067]. One of ordinary skilled in the art would be motivated to add PEG 20000 as additional protein stabilized to improve further stabilizing of the antibody of the antibody coated particle.
From the description in mind of Li, Yoshiaki, Coffman and Bao-feng, the various components of the freeze-drying composition of claim 1 are found to be commonly known and thus would be obvious to include in the freeze dying composition of Li. The combination of the references may involve some pick and choose of the components of freeze-drying composition, however, picking and choosing some commonly known compounds for the same purpose would be obvious and would provide Applicant’s freeze-drying composition in possession of the public at the time of Applicants invention was filed absent showing of unexpected advantages with a particular composition. Moreover, the indiscriminate selection of "some" among "many" is prima facie obvious, In re Lemin, 141 USPQ 814 (1964).
Regarding specific percentages of the protectants of claim 1, the compounds in the composition as described above are shown to be obvious and optimum concentration of the components can be determined by routine experimentation and thus would have been obvious to one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 223, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable is a known process is ordinary within the skill of the art.” Application of Boesch, 617 F.2d 272,276,205 USPQ 215, 218-219 (C.C.P.A. 1980).
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678