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 .
Information Disclosure Statement
An IDS has not been filed in the instant application.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to CN2018113915670 filed 11/21/2018.
Claim Rejections - 35 USC § 101
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-12 are drawn to an imprinted gene GRB10 and/or DIRAS3, so a composition.
Claim 13 is drawn to a process of using the marker of claim 1.
Step 2A Prong One: Identification of the Judicial Exception
The claim(s) recite(s):
1. A marker used to detect invasive bladder cancer, wherein the marker is imprinted gene Grb10 and/or Diras3.
Imprinted Grb10 and/or Diras3 genes are naturally occurring (i.e. products of nature) and are therefore judicial exceptions.
2. Claim 2 is drawn to using formulas to calculate copy number variation.
The calculations of claim 2 are drawn to math and also read on processes that can be performed by the human mind and are therefore abstract ideas.
3. Claims 3-8 recite determining the type of bladder cancer by analyzing the total expressed quantity of imprinted gene Diras3 and the total number of express quantity of the imprinted gene Grb10, and analyzing the Grb10 copy number variation, and calculating an infiltration factor as a ratio of the expressed quantity of the Brb10 with a copy number variation of the imprinted gene Diras3.
These claims are drawn to an abstract idea because calculating the total number of expressed Diras3 and Grb10, a copy number variation and a ratio can be performed by the human mind. The claims also recite mathematical concepts which are the percentages and ratio, which are an abstract idea.
4. Claims 9-12 are drawn to characterizing the Grb10 as being expressed in a bladder cancer invasive cell line and Diras3 as not expressed in the invasive bladder cancer cell line. Wherein the cancer cell line is any one of or combination of T24, J82 and UMUC3
This limitation describes a natural phenomena and is therefore a judicial exception. The limitation correlates Grb10 with invasive bladder cancer cell line and Diras3 as not being found in the invasive bladder cancer. This is a natural correlation and a natural phenomena. T24, J82 UMUC3 (claim 10) and 5637 cell lines (claim 12) are known bladder cancer cell lines. The recognition that Grb10 and Diras3 are expressed in these cell lines is a recognition of a natural principle.
5. Claim 13 is drawn to a use of the marker Grb10 or Diras3 in preparing a drug or reagent for diagnosis blader cancer.
The claim does not recite specific steps performed to achieve the recited “use.” The claim therefore reads on an abstract idea such as measuring and analyzing expression of the gene Grb10 and Diras3. Furthermore, the claim is focused on the nature based product and therefore also drawn to the product of nature.
Step 2A Prong Two: Consideration of Practical Application
The claims do not recite any additional elements that integrate the judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
Staining cells with hematoxylin, as in claim 2
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because hematoxylin staining for histological slides and cellular analysis is well known, routine and conventional.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 2-13 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 pre-AIA the applicant regards as the invention.
Claim 2 is a process step drawn to formulas that describe calculating the expressed quantity of the imprinted gene of claim 1, as the total quantity, the quantity being normal, the quantity with a loss of imprinting and the quantity with a copy number variation. It is unclear how claim 2 is intended to further limit claim 1. Claim 1 is drawn to a “marker” which is that Grb10 or Diras3 gene. Claim 1 is a product. However, claim 2 recites process steps and does not serve to further limit any structural features of Grb10 or Diras3 genes which are products.
Claims 3-8 are drawn to determining the type of bladder cancer by analyzing the total expressed quantity of imprinted gene Diras3. The claims calculate the total expressed quantity of the imprinted gene Grb10, analyze the Grb10 copy number variation, and calculate an infiltration factor as a ratio of the expressed quantity of the Brb10 with a copy number variation of the imprinted gene Diras3. The claims are drawn to process step and yet they depend off of claim 1 which is drawn to a product, i.e. the imprinted gene Grb10 or Diras3. It is not clear how the process of claims 3-8 is intended for further limit the product. It appears Applicants are reciting process claims as being dependent from a product and therefore do not further limit the product.
Claim Rejections - 35 USC § 112(d)
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 2-8 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 2-8 are drawn to process or method steps but depend on claim 1 which is drawn to gene markers Grb10 and/or Diras3 which are product claims (i.e. things). Claims 2-8 do not limitation that further limit the structures or features of the product and instead recite limitations of determining the type of bladder cancer and expressed quantities of the gene markers to determine an infiltration factor. The limitations of claims 2-8 do not further limit the structure or function of the marker of 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
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 -
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-13 are rejected under 35 U.S.C. 102(a) as being anticipated by Uribe-Lewis et al. (Expert Reviews in Molecular Medicine vol. 13 (2011) pgs. 1-22).
Claims 1-8 are drawn to imprinted genes Grb10 or Diras3.
Uribe-Lewis et al. teach both imprinted Grb10 (page 11, col. 1, par. 3) and Diras3 (page 11-12, connecting par.); Uribe-Lewis teach that GRB10 is maternally expressed and Diras3 is paternally expressed (Figure 2, caption).
It is noted that the limitations of claims 2-8, while drawn to process steps, are describing determining natural characteristics of the markers Grb10 and Diras3, and are therefore inherent.
Claims 9-12 are drawn to imprinted gene Grb10 being expressed in invasive bladder cancer and Diras3 not being expressed in invasive bladder cancer, and the bladder cancer cell lines being T24, J82, UMUC3 and 5637. The claims recite inherent or natural characteristics of the Grb10 and Diras3.
Uribe-Lewis et al. teach review imprinted genes including wit regard to their roles in epigenetic predisposition to cancer and speculate on the clinical applications of epigenetic drugs in cancer (Abstract). Uribe-Lewis et al. also teach the detection of imprinting loss as being associated with cancer (page 2, col. 2, par. 2). The teachings of Uribe-Lewis et al. therefore read on a “use of the marker” in preparing a drug or reagent for diagnosing bladder cancer, as in claim 13. Claim 13 does not recite specific steps for how the marker is used.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-7035. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635