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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/19/2026 is acknowledged.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Claims 1-5 are being examined on the merits.
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 2 and 5 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 2 recites the limitation "the anticoagulant" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite “the anticoagulant”.
Claim 5, recites “activated carbon is not treated” and it is not clear what this limitation requires or does not require. The limitation is confusing and indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 already requires “trisodium citrate” and so the claim does nor further limit the claim form which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sichuan University, Liu Xuewen Xu (from IDS, CN1843147), hereinafter Xu.
Regarding claims 1-2, Xu teaches collecting blood from an animal and treating with 8 grams of trisodium citrate per liter of blood (see step 1, embodiment 2, page 9 or part 4, page 11), separating to obtain plasma with a centrifuge (see part 2, embodiment 2, page 9 or claim 1, (1)), and teaches treating the plasma with proteinase (see claim 8 or part 6, page 11), adding 3-4% carbon (see para. 8, page 6), and incubating conditions for denaturation treatment: the temperature is generally 80-85°C, and the time is generally 10-12 minutes (see part (4), pare 6). Xu also teaches spray-drying at 180-250 ℃ (see part 6, page 6) and microorganisms would be destroyed at such high temperatures.
Regarding claim 3, Xu teaches said alkali protease can be 2709 bacillus alkaline proteases (see 2nd to last para. page 6) and this is a known form of subtilisin.
Regarding claim 4, Xu teaches adding 5500～6000u/g blood cell and 4000～4500u/g blood plasma at enzymolysis process (see 2nd to last para. page 6).
Regarding claim 5, Xu does not require hemolysis of red blood cells or treating of carbon.
Xu does not specifically teach that the proteinase is added at 1% (w/v) to plasma or teach the specific temperature and time for incubation to inactivate enzymes. Xu also teaches using less trisodium citrate. However, Xu teaches ranges directly outside these parameters and it is prima facie obvious to optimize outside of known ranges. Also given the prior art and knowledge of those having ordinary skill in the art it would have been obvious to know how to inactive the proteinase enzyme and to optimize the amounts of anticoagulant, etc. These are common and conventional knowledge to those having ordinary skill in the art and do not make the instant application patentably distinct from the prior art.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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