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 .
Priority
This application claims priority to Chinese application 202210098021.6 (fd 1/26/2022).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. English translation of the foreign application is not found in application 18/156775, so the priority date for art is 1/19/2023 until the English translation is provided.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/19/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. An http: link are found on Page 5 Column 3, Pg 6 Col 3, Pg 11, Pg 13.
Claim Objections
Claims 1 is objected to because of the following informalities:
Step (1) “PCR amplify an DNA” is grammatically incorrect. Remedy by removing “an”.
Step (4) begins with the word ”conducting” which is mistakenly spelled with two C’s at the start of the word.
Claims 4 is objected to because of the following informalities: “keeping” a temperature…is improper English but the use of a 4 degree hold or maintain at 4 degrees would be acceptable.
Claim 5 should have a space between the (2) and the as in line 3. Additionally, please use “(SAP)” after the first recitation of the phrase shrimp alkaline phosphatase so that it is entirely clear what SAP as a component of your recipe, references.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-6 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 is indefinite over the recitation disclosed in step (2) purifying… by an alkaline phosphatase since technically alkaline phosphatase does not purify, and thus it is unclear whether this is a purification step that includes alkaline phosphatase and other products or whether this is a particular reference to alkaline phosphatase to, for example, dephosphorylate remaining dNTPs, or for a different purpose. Additionally, in step (4), it is unclear to what “conducting sample application on an extended product onto a chip for mass spectrometry detection” references. Additionally, in the wherein clause it is unclear whether the claim is disclosing that the amplification primers and extension primers are in the same tube as one another or each set of primers is in a (different) tube, and whether all 186 sequences (primers) are found in one singular tube. Claim 1 is indefinite in the recitation of the use of amplification primers and extension primers since the claim does not clearly indicate whether all of the primers are used, and if that is in one tube, or whether one set could be used, or other numbers of primers could be used. Claims 2-6 depend from claim 1 and are indefinite for the same reason.
Claim 5 is indefinite over the recitation of, “and a premixed solution…”. It is unclear what the intent is regarding the premixed solution since there is no verb that relates to the solution, so it is not entirely clear how the premixed solution relates to the method. Claim 6 depends from claim 5 and is indefinite for the same reason.
Claim 6 contains the trademark/trade name “iPLEX”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular vendors extension buffer, extension termination mix and single-base extension reaction enzyme, and, accordingly, the identification/description is indefinite.
Claim 6 is also indefinite in the recitation of “wherein a single-base extension and amplification system in Step (3) is below:” since it is not entirely clear what the intended method step of this claim is meant to be.
Related but distinct art of record:
Denomme (US2008/0261205 A1 published Oct 23, 2008) was also interested in blood groups and avoiding adverse transfusion reactions, and recognized the value of screening red blood cells antigens (Abstract). Deonmme developed a multiplex-PCR-oliognucleotide extensions assay to genotype blook for blood groups and antigen associated SNPs (Abstract).
Denomme disclosed similar methods to ‘775, claim 1, for example, involving amplification primers to multiplex PCR to amplify DNA from a blood sample to detect a plurality of blood groups in a single tube (Abstract, claims 4,14, 33), wherein the amplification primers include forward primers and reverse primers (primer sets from Table 1), where the SEQ ID Nos of the instant application and that of Denomme do not appear the same, nor are the instant sequences obvious in view of Denomme.
Re: ‘775 claim 1 step (2) purifying an amplification product obtained in Step (1) by an alkaline phosphatase, Denomme (claim 14) simultaneously analyzes antigens by a method of isolation and purification of genomic DNA, multiplex PCR, digestion and identification of SNPs and where claim 15 articulates that (shrimp alkaline phosphatase) SAP is used to removed excess dNTPs/oligonucleotides (e.g. purify). Re: ‘775 step (3) using extension primers to extend the purified product in Step (2) by a single base, and ‘775 step (4) conducting sample application on a single-base extended product obtained in Step (3) onto a chip for mass spectrometry detection Denomme disclosed extension products that were hybridized to tag-arrayed microplate (claim 16), where DNA fragments generated during a primer extension reaction, like single base extension, where primer binds next to target and DNA polymerase adds one or few nucleotides and newly extended product is the extension product with the target specific sequence (claim 14, 16); ‘775 wherein the amplification primers and the extension primer mix are included in a tube, Denomme disclosed the method of claim 14 (purify DNA, multiplex amplify, digest, id SNPs using single-base pair primer extension of amplified fragments, hybridize extension products and analyze SNPs) is carried out in a single reaction tube (claim 21 for blood group and HPA SNPs, claim 26). The sequences claimed are different in these applications.
Ye (US2023/02353;90 A1, filed 1/192023) with additional inventors to ‘775, has been reviewed for double patenting and while, for example claim 1 appears substantially similar, the SEQ IDs claimed differ from the instant application and the instant application sequences are not obvious in view of the art.
Conclusion
All claims rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8-4 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, Gary Benzion can be reached at (571) 272-0782. 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.
/LISA HORTH/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681