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 .
Status of the Claims
Claims 1-28 are cancelled.
Claims 29-59 are pending.
Claims 37-59 are withdrawn.
Claims 29-36 are under examination.
Election/Restrictions
Applicant’s election of Group 1, claims 29-36 in the reply filed on 7 July 2026 is acknowledged. Applicant also elected: 177LU, SCLC, paraffin-embedded and fixed biopsy sample, and DNA damage response inhibitors. 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)).
Claims 37-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7 July 2026.
Claim Objections
Claims 29, 30, and 33 are objected to because of the following informalities: the claims recite abbreviations for the first time without identifying what the abbreviation is. For example, in claim 29, the abbreviation CCKBR and CCK2R are used. It appears that the full name is used earlier in the claim, however applicant should place the abbreviation after the name.
Claim 29 recites “for the mRNA expression level” in part (a) and it should read “for an mRNA expression level.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 30 and 31 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. The claims do not add additional limitations to the active method steps of claim 29. Note that while the claims limit the specific compound the compound is not required to perform the active steps of the method. 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 § 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 29-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon and an abstract idea) without significantly more. The claim(s) recite(s) predicting a response of a patient diagnosed with cancer to treatment and/or imaging with a compound targeting cholecystokinin 2 receptor. This judicial exception is not integrated into a practical application based on the reasoning below:
The unpatentability of laws of nature and abstract ideas was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S., (2010) (slip op., at 5). “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972).
Additionally, the unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Inti, 134 S. Ct. 2347, 2354 (2014).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claims are directed to a method.
Step 2A, prong 1. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, where the claims recite a step of determining a biomarker level and predicting response to a treatment or imaging, they encompass the mental comparison of data and the correlation of data and information to reach a conclusion. Further, the treatment decision is based on a law of nature or natural phenomenon because it is based on a level of a biomarker already occurring in the subject.
Step 2A, prong 2. Does the claim recite additional elements that integrate the exception into a practical application? No, the judicial exceptions to which the claims are directed are not integrated into a practical application because the rejected claims do not require any particular practical steps related to the determining a biomarker level and predicting response to a treatment.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims assay a tumor sample and determine an expression level to predict treatment response.
For these reasons, the claims are rejected under USC 35 section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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(s) 29, 32, 33, and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsumori et al. (Cancer Research, 1995).
Matsumori et al. teach assaying a tumor sample from both lung cancer and matched normal lung tissues. (page 276). Matsumori et al. teach examining the expression of CCK-B/gastrin receptor mRNA in human lung cancers. (page 277). Matsumori et al. teach that expression of CCK-B/gastrin receptor mRNA was not detected in normal lung tissues. (page 277). Matsumori et al. teach CCK-B/gastrin receptor was detected in all SCLCs. (page 277).
Matsumori et al. teach the active steps of claim 29. The active steps of claim 29 are assaying a tumor sample from a patient diagnosed with cancer for an mRNA expression level of CCKBR. Matsumori et al. teach this step.
The second active method step of claim 29 is determining whether the mRNA expression level of CCKBR is equal to, or greater than a predetermined cut-off range. The rest of part (b) is the result. Matsumori et al. teach the active method step of (b).
Regarding the wherein clause of claim 29, The MPEP 2111.04 states that a "wherein" clause limits a process claim where the clause "meaning and purpose to the manipulative steps". In the instant case, the "wherein" clause does not give meaning and purpose to the manipulative steps. Rather, it attempts to recite an intrinsic property of the samples tested in the claim. The active method steps of the claim do not require a type of treatment or a compound. They only require measuring an mRNA level in a sample and determining if it meets a cutoff value. Matsumori et al. teach tumor samples with greater values than non-tumor samples.
Regarding claims 32 and 33, Matsumori et al. teach tumor samples from patients with SCLC. (page 277).
Regarding claim 35, Matsumori et al. teach the use of RT-PCR. (page 276).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumori, et al. (Cancer Research, 1995) in view of Godfrey et al. (Journal of Molecular Diagnostics, 2000).
The teachings of Matsumori et al. are applied to claim 34 as they were applied to claims 29, 32, 33, and 35 above. Matsumori et al. does not teach wherein the tumor sample is a biopsy sample that is paraffin-embedded and fixed biopsy sample. Godfrey et al. teach quantitative mRNA expression analysis from formalin-fixed, paraffin-embedded tissues using RT-PCR. Godfrey et al. teach that formalin-fixed, paraffin embedded tissues proved comparable results to fresh RNA samples allowing for samples to be tested after they are harvested. Therefore, one of ordinary skill in the art would be motivated to use a tissue storage method that shows comparable results to a method on fresh tissue samples allowing testing to be carried out at a later time and not in the surgical suite.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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/MINDY G BROWN/Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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