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
Claim 1 is directed towards a method of quantification of B regulatory cells in a patient. The term “quantification” will be interpreted as any process that determines a number of cells, such as cell counting, flow cytometry, or other quantitative procedures. Therefore, art reading on a method of quantification of B cells which involves determining the number of B cells in a sample will be considered as satisfying the method of claim 1.
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 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the stepwise method of measuring the quantification of B regulatory cells and instructions on how to carry out said quantification steps. Claim 1 as written simply states that the method is directed to quantification of B regulatory cells in a patient, but makes no further mention of how the method is to be carried out. Claims 2-17 do not further limit claim 1 as claims 2-17 are directed towards the cells being quantified, not how to carry out the quantification process.
Furthermore, there is no relation between the quantifying steps and the intended purpose of the claims. Dependent claims 2-10 are directed towards required expression markers in the population of B cells and dependent claims 11-17 detail what the intended population of B cells are required to do, but independent claim 1 gives no concrete steps regarding how to carry out the method step of “quantification of B regulatory cells in a patient” and how this predicts a response to mesenchymal stem cell therapy.
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.
Claims 2-17 are 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. Claims 2-17 are directed towards the cells being quantified, but fail to detail any actual method steps regarding how the quantification of said B cells is to be carried out. In order to further limit the independent claim 1, the dependent claims must further specify the method steps needed to carry out the quantification of B regulatory cells as stated in claim 1. 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 § 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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et. al (CN 115160433 A)
Liu teaches methods of preparation and application of PBMCs, including B cell monoclonal sequencing, for use in the prevention, treatment, and/or detection of hepatitis B. (Pg 1, Abstract) Specifically, Liu teaches a method of antigen-specific B cell flow cytometry sorting based on the marker CD19 which utilizes flow cytometry. The B cells are isolated from PBMCs isolated from a mouse. (Pg 15, entire page) This reads on a method of quantification of B regulatory cells in a patient. The results of the flow-cytometry based isolation can be seen below in Fig. 1:
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Regarding claims 2-17: Based on the rejection over 35 U.S.C. 112(d), claims 2-17 are not further limiting independent claim 1. Therefore, as dependent claims inherit the teachings of the independent claim they depend from, claims 2-17 are rejected by the teachings of Liu et al. based on the reasons set forth in the discussion above regarding claim 1, as claim 1 teaches a method of quantification of B regulatory cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. 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, Tracy Vivlemore, can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HANNA MARIE THUESON/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638