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 of Group IV in the reply filed on 10/09/2025 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)).
Claims 1-20 are pending.
Claims 1-10 are withdrawn.
An action on the merits for claims 11-20 is set forth below.
Claim Objections
Claims 11-20 are objected to because of the following informalities: The claims should be listed as “1.” Instead of “(1)”. Appropriate correction is required.
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.
Claims 11-20 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.
Claims 11 is indefinite over the phrase “elevated expression”. The term “elevated expression” in claim 11 is a relative term which renders the claim indefinite. The term “elevated expression” 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. As there is no comparison step it is not clear which expression would be considered “elevated”.
Claims 12 is indefinite is indefinite over the phrase “elevated expression”. The term “elevated expression” in claim 12 is a relative term which renders the claim indefinite. The term “elevated expression” 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. As there is no comparison step it is not clear which expression would be considered “elevated”.
Claims 13-14 are indefinite over the phrase “elevated expression”. The term “elevated expression” in claim 13-14 is a relative term which renders the claim indefinite. The term “elevated expression” 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. As there is no comparison step it is not clear which expression would be considered “elevated”.
Claims 15-20 are indefinite over the measuring step of measuring the absence, presence or expression level and the step of administering. The step of administering occurs based upon “measuring increased levels” and as such it is not clear if administering occurs during a step of measuring absence or presence. Therefore the metes and bounds are unclear.
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 11-20 are 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.
The claims are drawn administering based upon elevated expression of PRSS21 in any sample from any subject. Therefore the claims encompass administering based upon expression level however, the specification does not describe administering in any subject based upon expression levels in any sample.
The specification discloses PRSS21 expression and associations with cancers (p. 7). The specification describes AML human patients and tissue (p. 22-23). However, the specification does not describe the functionality of expression in any subjects or samples. The art, as presented below, teaches that expression levels in samples and subject are not functionally the same. Further, the specification does not provide that presence or absence of PRSS21 has any association with administration.
The art does not provide the critical structural elements for the asserted functionality. In particular Enard et al. (Science 2002 Vol 296 p. 340) teaches that even between closely related species gene expression patterns differ (abstract). Enard et al. teaches that mRNA expression levels are different between humans, chimpanzees, orangutans and rhesus marcques (p. 340 1st column last sentence-2nd column 1st paragraph). Enard et al. teaches that there are a large number of quantitative differences in gene expression in closely related mammals (p. 342 2nd column last paragraph). Therefore the art teaches that even between very closely related mammals there is a divergence of gene expression. As such Enard et al. teaches that merely being a biomarker in one species would not be sufficient to provide support for the structure in other species.
The claims encompass any sample. The art of Cobb et al (Crit Care Med 2002 Vol. 30 p. 2711) teaches the unpredictability in analysis of gene expression in spleen and liver sample from septic mice. Notably, the reference teaches that, when compared to a non-septic sample, the relevant expression profiles of the septic mouse spleen and the septic mouse liver contain different nucleic acids at different levels (Table 1; p.2714, middle col., lns.2-8). As such the art teaches that expression levels of the same nucleic acids in different tissue samples differ. Therefore the art indicates that an association of expression level to a disease in one sample would not be described to an association to any other sample type.
Accordingly, the specification has not provided the critical elements needed in the structure to predictive functionally. Therefore the specification lacks written description of any subject representative of the broadly claimed genus.
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.)
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) 11,12,15-17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golz et al (WO2006/013016 February 9, 2006)
With regard to claim 11, Golz et al. methods of administering to a subject with cancer aniti-PRSS21 antibodies (p 26-27 and 49). Golz et teaches that PRSS21 can be expressed in cancer tissues (p. 52). The claims do not require any particular level of elevation and therefore expression of PRSS21 encompasses the claim language.
With regard to claim 12, Golz et al. methods of administering to a subject with AML aniti-PRSS21 antibodies (p 26-27 and 43). Golz et teaches that PRSS21 can be expressed in cancer tissues (p. 52). The claims do not require any particular level of elevation and therefore expression of PRSS21 encompasses the claim language.
With regard to claim 15, Golz et al. teaches that the subject is suffering from a PRSS21 associated disorder (e.g. cancer p. 49). Golz et al. teaches measuring the level of PRSS21 in a sample with a detection agent (p 31). Golz et al. teaches administration of an antibody to PRSS21 in patients with increased levels of expression (p. 26-27 and 62).
With regard to claims 16-17, Golz et al teaches that the disorder is AML (cancer) (p. 43).
With regard to claim 19, Golz et al. teaches measurements using qPCR (p 69).
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.
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) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golz et al (WO2006/013016 February 9, 2006) in view of Loew et al. (US Patent Application Publication 2017/0335281 November 23, 2017).
With regard to claim 13, Golz et al. methods of administering to a subject with AML aniti-PRSS21 antibodies (p 26-27 and 43). Golz et teaches that PRSS21 can be expressed in cancer tissues (p. 52). The claims do not require any particular level of elevation and therefore expression of PRSS21 encompasses the claim language. Golz et al. does not teaches administration of a CAR-T cell.
With regard to claim 20, Golz et al. teaches that the subject is suffering from a PRSS21 associated disorder (e.g. cancer p. 49). Golz et al. teaches measuring the level of PRSS21 in a sample with a detection agent (p 31). Golz et al. teaches administration of an antibody to PRSS21 in patients with increased levels of expression (p. 26-27 and 62).
Golz et al. does not teaches administration of a CAR-T cell. However, Golz et al. does suggest the use of chimeric antibodies for treatment (p. 27 and 62).
With regard to claims 13 and 20, Loew et al. teaches the treatment of tumors with expression increases in PRSS21 with CAR-T cells (chimeric antigen receptor T cells (claim 2 and paragraph 1209).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Golz et al. to treat the subjects with CAR-T cells. Golz et al. suggests that chimeric antibodies can be designed and therefore it would be obvious to modify the method to use known methods of treating with CAR-T cells such as taught by Loew et al. The ordinary artisan would have a reasonable exception as Loew et al teaches treatment with these cells.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golz et al (WO2006/013016 February 9, 2006) and Loew et al. (US Patent Application Publication 2017/0335281 November 23, 2017) as applied to claims 13, 20 and in view of Ostertag et al. (WO 2018/169948 September 20, 2018).
Golz et al. methods of administering to a subject with AML aniti-PRSS21 antibodies (p 26-27 and 43). Golz et teaches that PRSS21 can be expressed in cancer tissues (p. 52). Loew et al. teaches the treatment of tumors with expression increases in PRSS21 with CAR-T cells (chimeric antigen receptor T cells (claim 2 and paragraph 1209).
However, Golz et al and Loew et al. do not teach treatment of an AMKL subtype of AML.
With regard to claim 14, Ostertag et al. teaches that designing CAR-T cells for the treatment of AMKL (claim 126 paragraphs 118-124).
Therefore it would be prima facie obvious at the time of the effective filing date to modify the method of Golz et al. and Loew et al. to treat a subtype of AML such as the AMKL subtype taught by Ostertag et al. The ordinary artisan would be motivated to use any of the finite number of AML cancer types including AMKL subjects and treat the subject with administration of a known treatment.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golz et al (WO2006/013016 February 9, 2006) in view of Ostertag et al. (WO 2018/169948 September 20, 2018).
Golz et al. teaches that the subject is suffering from a PRSS21 associated disorder (e.g. cancer p. 49). Golz et al. teaches measuring the level of PRSS21 in a sample with a detection agent (p 31). Golz et al. teaches administration of an antibody to PRSS21 in patients with increased levels of expression (p. 26-27 and 62). Golz et al teaches that the disorder is AML (cancer) (p. 43).
However, Golz et al. does not teach treatment of AMKL subtype of AML.
With regard to claim 18, Ostertag et al. teaches that designing CAR-T cells for the treatment of AMKL (claim 126 paragraphs 118-124).
Therefore it would be prima facie obvious at the time of the effective filing date to modify the method of Golz et al. to treat a subtype of AML such as the AMKL subtype taught by Ostertag et al. The ordinary artisan would be motivated to use any of the finite number of AML cancer types including AMKL subjects and treat the subject with administration of a known treatment.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682