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 .
DETAILED ACTION
Status of Claims
Claims 1-37 and 44-48 are pending. Claims 3-4, 6-15, 17-20, 22, 24-25, 28-31, 33-37 and 44-47 have been withdrawn. Claims 1-2, 5, 16, 21, 23, 26-27, 32 and 48 have been examined.
Election/Restriction
Applicant’s election of Group I, claims 1-2, 5-6, 14-27, 31-37 and 45-48, in the reply filed on 03/09/2026 is acknowledged. Additionally, Applicant’s election of species of claim 5, claim 16, claim 21, claim 23, claim 32 and claim 48, in the reply filed on 07/28/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application, Serial No. 18/302,603 (PGPub: US2023/0355599) was filed 07/24/2023. This application claims benefit of US Provisional Patent Application 63/332,523 filed 04/19/2022 and 63/339,866 filed 05/09/2022.
Information Disclosure Statements
The Information Disclosure Statement filed 08/30/2023 has been considered by the Examiner.
The information disclosure statement filed 07/24/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 1-2, 5, 16, 21, 23, 26-27, 32 and 48 are objected to because of the following informalities:
The claims recites the acronym “CBL”, without first providing the full name of the term. It is suggested that the term be spelled out at their first use and in all independent claims so that it is clearly understood what they stand for.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5, 16, 21, 23, 26-27, 32 and 48 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2 recites measuring the amount of a CBL biomarker in the sample. Additionally, withdrawn species claim 31 and examined species claim 32 recites the CBL biomarker is selected from phosphorylated interleukin-2-inducible kinase (pITK), phosphorylated hematopoietic lineage cell-specific protein (pHS 1), phosphorylated phospholipase C2 (pPLCy2), phosphorylated phospholipase C1 (pPLCyl), phosphorylated spleen tyrosine kinase (pSYK), and phosphorylated Zeta-chain-associated protein kinase 70 (pZAP70), and more specifically the elected biomarker is phosphorylated interleukin-2-inducible kinase (pITK).
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc) (MPEP §2163.03.V).
“[T]he disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." (MPEP § 2163.II.A).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.") (MPEP § 2163).
Claims 1 and 2 are broadly drawn to any CBL biomarker.
The specification fails to disclose a broad genus of CBL biomarkers of all possible biomarkers for CBL as it only discloses phosphorylated interleukin-2-inducible kinase (pITK), phosphorylated hematopoietic lineage cell-specific protein (pHS 1), phosphorylated phospholipase C2 (pPLCy2), phosphorylated phospholipase C1 (pPLCyl), phosphorylated spleen tyrosine kinase (pSYK), and phosphorylated Zeta-chain-associated protein kinase 70 (pZAP70).
Therefore, claims 1-2, 5, 16, 21, 23, 26-27, 32 and 48 are rejected under 35 U.S.C. 112(a) for failure to describe the broad genus of all CBL biomarkers that can be used to identify the amount of CBL in the sample.
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 1-2, 5, 16, 21, 23, 26-27, 32 and 48 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 because it recites a step of measuring an amount of a CBL biomarker and identifying the amount of CBL based on the amount of the biomarker, however there appears to be a missing link within the claim as to how the amount of the biomarker can then identify the amount of CBL.
Claim 1 is unclear because step a. recites measuring and step b. later states that the identifying is based on the amount of CBL biomarker detected in the sample, however the claim has not mentioned any detection step.
Claim 2 is indefinite because it recites measuring the amount of a CBL biomarker in a first and second sample and identifying a change in the amount of CBL based on the change in the amount of the biomarker, however there appears to be a missing link within the claim as to how the change in the amount of the biomarker can identify a change in the amount of CBL, especially since the two measuring steps have not provided any unique properties – for example, first and second samples taken at different times, after treatment, etc.
Claim 2 is indefinite because steps a. and b. recite measuring the amount of a CBL biomarker in a first sample and a second sample and it is unclear if the biomarkers are both the same or different that would then allow the amount of CBL to be determined.
Claim 48 is indefinite because it recites that the CBL is Cbl-b and c-Cbl but it is unclear if the CBL biomarker being measured in claim 1 is able to measure both subtypes mentioned in claim 48.
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 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim recites, “measuring and identifying a change in the amount of CBL based on the change in the amount of the CBL biomarker detected in the sample”. The claimed limitation of using the change in measured biomarker amount to identify the amount of CBL in the sample is a concept performed in the human mind belonging to the mental process grouping of the abstract ideas judicial exception (see MPEP § 2106.04(a)(2), subsection III). The judicial exception is not integrated into a practical application, such as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception (see MPEP § 2106.05(a)-(c), (e)-(h)) such that the invention does not preempt every observance of the natural phenomenon itself.
Eligibility Step 1:
Claim 2 is directed to a method for detecting the amount of CBL in a sample. Methods are one of the eligible statutory categories for invention (STEP 1: YES). However, eligibility of the claim is not self-evident, and therefore analysis must proceed to Step 2.
Eligibility Step 2A, Prong One:
The claim recites using the measured amount of change in CBL biomarker between two samples to identify the change in amount of CBL in the sample, which is an abstract mental concept that belongs to enumerated group (III) of the Abstract Idea Groupings described in MPEP § 2106.04(a)(2). Therefore, the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
Eligibility Step 2A, Prong Two:
According to Step 2A, Prong Two, set forth in MPEP 2106.04 II A (2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited within the claim. Claim 2 recites the additional steps of measuring the amount of a CBL biomarker in a first sample and measuring the amount of a CBL biomarker in a second sample.
Regarding the additional steps cited in claim 2, measuring the amount of CBL biomarker is insufficient to integrate the judicial exception(s) because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).
There are no other additional elements that apply, rely on or use the judicial exception such to integrate it into a practical application. For example, there are no additional elements that apply the abstract idea judicial exception to a particular treatment or which utilize a particular machine; there are no additional elements that effect a transformation; and, there are no additional elements that apply the judicial exception in some other meaningful way beyond generally linking it to a field, namely, assessing oral cancer. In this way the claims, as drafted, do not integrate the judicial exception into a practical application that would overcome monopolizing the exception. ((STEP 2A, Prong Two: NO).
Eligibility Step 2B:
Lastly, the examiner cites publications within the field of technical expertise, that demonstrate the well-understood, routine, conventional nature of the additional element(s).
Regarding the steps/elements recited in addition to using the measured amount, Kaminski (US 2018/0101642) teaches measuring expression levels of ITK (paragraph 0047) – which applicant’s specification teaches is a biomarker of CBL.
Therefore, the steps/elements recited in addition to the judicial exception were all well understood, routine, conventional activities in the field of measuring biomarkers (STEP 2B: NO).
The claimed steps/elements recited in addition to the judicial exception(s), alone or in combination, do not amount to significantly more than that which was routine and conventional in the art prior to filing.
State of the Prior Art
The prior art fails to teach detecting the amount of CBL in a sample by measuring the amount of a CBL biomarker.
While the prior art teaches detection of ITK (an example of a CBL biomarker as identified by Applicant’s specification) as seen in Kaminski et al. (US 2018/0101642, paragraph 0047) and the prior art also separately teaches the detection of CBL as the biomarker itself as seen in Edwards et al. (US 2021/0015937, paragraphs 0266-0270), the prior art fails to teach a combination of measuring the amount of a CBL biomarker and then identifying the amount of CBL in the sample based on the amount of the CBL biomarker detected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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, Bao-Thuy L Nguyen can be reached at 571-272-0824. 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.
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
Prosecution Insights