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 in the reply filed on 8/10/2026 is acknowledged:
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Claim 1 covers the elected invention and is treated on the merits, below. Claim 2 is withdrawn from consideration as exclusively covering a non-elected invention.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claim is not directed to patent-eligible subject matter.
The PTO' s revised guidance on the application of§ 101. (USPTO's January 7, 2019, Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance indicates that we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., natural phenomena, mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not "well-understood, routine, conventional" in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Here, the claim clearly recites a process, which is a statutory class of invention (“A method for diagnosing or predicting bone metastasis of hepatocellular carcinoma in a subject, comprising: detecting a VAPA protein expression level in a blood sample obtained from the subject, wherein an elevated VAPA protein expression level relative to a reference level indicates hepatocellular carcinoma bone metastasis or an increased risk thereof.”).
However, determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) does not end the eligibility analysis, because claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection. These are the “judicial exceptions”. In addition to the terms “laws of nature,” “natural phenomena,” and “abstract ideas,” judicially recognized exceptions have been described using various other terms, including “physical phenomena,” “products of nature,” “scientific principles,” “systems that depend on human intelligence alone,” “disembodied concepts,” “mental processes,” and “disembodied mathematical algorithms and formulas.”
Here, the natural phenomena exception applies since the claim covers detecting expression level a naturally-occurring protein, and observing the natura principal that an elevated VAPA protein expression level relative to a reference level indicates hepatocellular carcinoma bone metastasis or an increased risk thereof.
The claim is then evaluated to determine if additional elements integrate the judicial exception into a practical application. Specifically, a claim that focuses on use of judicial exceptions must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
The Mayo framework provides that first whether the claims at issue are directed to a patent-ineligible concept is determined. If the answer is yes, then the elements of each claim both individually and "as an ordered combination" are considered to determine whether additional elements "transform the nature of the claim" into a patent-eligible application. The second step known as the "inventive concept"-requires that claims include elements which would render the method both new and useful.
The question then becomes: are there other limitations in the claim that show a patent-eligible application of the abstract idea, e.g., more than a mere instruction to apply the abstract idea?
If there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim should be rejected under 35 U.S.C.§ 101 as being directed to non-statutory subject matter.
One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment and thus transforms a claim into patent-eligible subject matter.
Examples of “treatment” and prophylaxis” limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011). (see MPEP 2106.04(d)(2))
In the present claims there are no active method of treating steps that transform the process into a practical application beyond measuring and identifying.
The next step is to determine whether the claim as a whole adds a specific limitation beyond the judicial exception that is not "well-understood, routine, or conventional" in the field.
Here, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the "measuring" steps represent routine data gathering to test for a correlation. Such steps would be routinely used by those of ordinary skill in the art to identify and apply a correlation.
Therefore, the claim recites a judicial exception drawn to natural phenomena. The claims do not include additional elements/steps that integrate the natural principle into the process, and the claim does not include additional elements/steps that amount to significantly more than the natural principle itself.
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.
Claim 1 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.
The term “elevated VAPA protein expression level” in claim 1 is a relative term which renders the claim indefinite. The term “elevated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over MYBIOSOURCE.com, Product Documentation, (Vesicle-Associated Membrane Protein)-Associated Protein A, 33kDa (VAPA) ELISA Kit for Human, downloaded 24 August 2026 from https://www.mybiosource.com/human-elisa-kits/vamp-vesicle-associated-membrane-protein-associated-protein-a-33kda-vapa/2610981#related-product-information (ELISA).
ELISA teaches VAPA kits and methods for VAPA detection and serum concentration. The kit utilizes the Double Antibody Sandwich ELISA technique. The pre-coated antibody is an anti-Human VAPA monoclonal antibody, while the detection antibody is a biotinylated polyclonal antibody. Samples and biotinylated antibodies are added into ELISA plate wells and washed out with PBS or TBS after their respective additions to the wells. Then Avidin-peroxidase conjugates are added to the wells in after. TMB substrate is used for coloration after the enzyme conjugate has already been thoroughly washed out of the wells by PBS or TBS. TMB reacts to form a blue product from the peroxidase activity, and finally turns to yellow after addition of the stop solution (Color Reagent C). The color intensity and quantity of target analyte in the sample are positively correlated.
The product manual does not teach that an elevated VAPA protein expression level relative to a reference level indicates hepatocellular carcinoma bone metastasis or an increased risk thereof. However, ELISA substantially teaches that the required VAPA detection methods were known. Any observed correlation between VAPA protein expression level and hepatocellular carcinoma bone metastasis would have been an invariable aspect of this assay, and therefore, prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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