DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-17 are under examination.
Claim Rejections - 35 USC § 112
2. 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.
Claim 8 is 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.
Instant claim 8 recites “A method of developing or manufacturing a device for screening UPD, comprising applying the method of detecting a uniparental disomy based upon NGS-trio according to claim 1.” However, it is unclear how applying the method of claim 1 will develop or manufacture a device for screening UPD. Clarification via clearer claim language is required.
Claim Rejections - 35 USC § 101
3. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 9-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
4. Claims 1-7, and 9-17 are directed to method and device for detecting a uniparental disomy based upon NGS-trio. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the steps of screening for mutation sites, merging mutation site data, classifying inheritance pattern, judging genetic relationship, judging uniparental fragment, judging UPD, and screening pathogenic UPD. However, these steps are drawn to mental steps. Dependent claims 2-7 and 9-17 also recite mental steps. Mental steps are a judicial exception. Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite the additional element of obtaining data. The steps of obtaining data is an extra solution data gathering step. Extra solution data gathering steps are not sufficient to integrate the judicial exception into a practical application. The instant claims also recite a device, a storage medium and processor. However, the instant claims do not recite structural limitations of these elements. Thus, the instant claims do not recite a particular machine that integrates the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of obtaining data. However, the element of obtaining data is well-understood, conventional and routine (Specification, page 11). The element of a device, a storage medium and processor are well-understood, routine, and conventional components of a computer (Specification, page 8). Reciting such well-understood, routine, and conventional data elements do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data, to be used in the judicial exception, does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying the types of data for a data gathering step. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
5. Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter.
Instant claim 16 is drawn to a storage medium. A storage medium encompasses carrier waves, which are non-statutory per se. Thus, the instant claim is drawn to non-statutory subject matter.
Claim Rejections - 35 USC § 102
6. 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.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by King et al. (“A Novel Method for Detecting Uniparental Disomy from Trio Genotypes Identifies a Significant Excess in Children with Developmental Disorders” Genome Res. (2014) volume 24, pages 673-687).
Instant claim 17 recites “A processor, for running a program that realizes the functions of the modules according to claim 9.” This instant claims is written as an intended use for the processor. An intended use does not limit the instant claim. Thus, the instant claim is drawn to a processor.
King et al. teach a using software to carry out their method, which would require a processor (page 685, right column).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY LIN/ Primary Examiner, Art Unit 1685
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