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 .
Claims 1-16 are pending.
An action on the merits is set forth below.
Claim Objections
Claims 12, 14-16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from multiply dependent claims. See MPEP § 608.01(n). Accordingly, the claims 4-25 not been further treated on the merits.
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 1-11 and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-11 and 13 are indefinite. Claim 1 is drawn to treatment based upon the level of malignancy. The claims require “determining the level” based upon the combination of overall gene score, however, the claims do not provide which levels are used to the treatment. As such it is not clear how to perform the treatment step.
Claim Rejections - 35 USC § 112/Written Description
The following is a quotation of the first paragraph of 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.
7. Claims 1-11 and 13 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to methods of determining levels of malignancy of thyroid tumor and treating based upon that level. The claims encompass comprising calculating total expression, biallelic expression and multiallelic expression, wherein the genes are HM13 and Snrpn.
The rejection of claims for lack of adequate written description is based upon the requirement of the claims of calculating to grade the expression of Z1 and Z16 in order to provide thyroid level and treatment. In the instant case the specification does not provide the skilled artisan with an adequate written description of particular grading of Z1 and Z16 suitable for determination of level for any particular treatment
While the specification describes for the imprinted gene Z1/G16, Grade 0 is defined by a loss of imprinting of less than 15%, CNV less than 2% or the total expression is less than 25%(para 31) it not describe grading of any cancer in any sample from any species and diagnosis or treating. The specification asserts that the term "subject" in the claims refers to any organism. However, imprinting between samples in any species would differ. The specification has not described the breadth of these calculations.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. The instant specification has not provided the critical structures required to functionally predict cancer treatment based upon any grading expression of Z1 and Z16 using the recited measurement formula. The specification has not provided which treatments were correlated to any particular levels.
Herein, no common element or attributes to distinguish the feature of the different components of expression genus. No structural limitations or requirements which provide guidance on the identification of sequences which meet these functional limitations. In particular, although, the specification has described particular calculations that provide particular functionality, the specification has not provided which calculations encompassed functionally determine any treatment.
Therefore, the specification and the art do not provide the critical structures required to determine if a species is functionally associated with cancer. Therefore the specification has not described the nucleic acids in such a way that the skilled artisan can determine which nucleic acids in the genus will functionally detect any cancer. Applicants' attention is directed to the decision in In re Shokal, 113 USPQ 283 (CCPA 1957) wherein is stated:
It appears to be well settled that a single species can rarely, if ever, afford sufficient support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.2d 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of small genus such as the halogens, consisting of four species, a reduction to practice of three, or perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably larger number of reductions to practice would probably be necessary.
In the instant application, because of the lack of any analysis regarding any calculation of imprinted genes of HM12 and SNRP and treatment, based upon levels one of skill in the art cannot envision the detailed calculated changes of these imprinted genes.
Thus, having considered the breadth of the claims and the provisions of the specification, it is concluded that the specification does not provide adequate written description for the claims.
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 1-11 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (abstract idea) without significantly more. The claim(s) recite(s) a step of calculating which is considered an abstract idea. This judicial exception is not integrated into a practical application because the steps does not integrate the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of treating is consider a generic recitation of performing a routine and conventional step of treating by any method a cancer sample.
Question 1
The claimed invention is directed to a method that recites abstract ideas.
Question 2A – Prong 1
The claims recite the patent ineligible concepts of abstract ideas or “calculating” and “grading”. The steps of calculating and grading are abstract ideas. Calculating and grading are mental processes that can be performed in the human mind, such as by observation, evaluation, judgment or opinion. Methods that can be performed in the human mind, or by a human using a pen and paper are considered abstract ideas. Thus, the calculating and grading steps constitute abstract ideas that include algorithms. The step of “treating” encompasses any step that provides any treating method to a population that encompasses thyroid cancer and therefore is considered no more than an ‘instruction to apply the natural law’ and fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself”.
Question 2A – Prong 2
The judicial exceptions are not integrated into practical application because the claims do not recite any additional elements that integrate the judicial exceptions into practical application of the exceptions. A treatment limitation must be “particular” i.e. specifically identified so that it doesn’t encompass all applications of the judicial exception. The treatment step does not indicate how the patient is to be treated, or what the treatment is, but instead coveys any possible treatment that a doctor decides to administer to a patient. Here, the generic treatment for cancer is not particular and is instead merely instructions to “apply” the exception in a generic way.
Accordingly, claim 1 is directed towards judicial exceptions.
Question 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims do not add a specific limitation other than what is well-understood, routine and conventional in the field. The step of calculating is the judicial exception. The step of treating the subject employs only potential techniques and treatments there were known to one skilled in the art.
Even when viewed as a combination, the additional elements of the claims fail to transform the exceptions into patent-eligible applications of the exceptions. Thus, the claims as a whole do not amount to significantly more than the judicial exceptions themselves. The steps outlined above are merely well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, applied to the steps of calculating the expression values and grading the expression values. The claims do not recite additional elements that amount to significantly more than the judicial exceptions.
Zhou et al. (Clinical Epigenetics 2021 Vol 13 p. 220) in view of Cheng et al. (US Patent Application 2022/0275459 September 1, 2022) teaches obtaining a test sample and preforming ISH using probes to intron regions of HM13 and SNRPN (figure 2 and p. 2). Zhou et al. teaches hybridization and staining (p. 2 and figure 2). Zhou et al. teaches calculation of total expression, biallelic expression and multiallelic expression based upon there microscopic images (p. 2 1st column). Figure 2 and pages 11-12 provide methods of measurement with the formula. Zhou et al. teaches using these measurements for treatment decisions (p. 11). For those reasons, claim 1 is rejected under section 101 as being directed to non-statutory subject matter.
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 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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (Clinical Epigenetics 2021 Vol 13 p. 220) in view of Cheng et al. (US Patent Application 2022/0275459 September 1, 2022)
With regard to claim 1, Zhou et al. teaches obtaining a test sample and preforming ISH using probes to intron regions of HM13 and SNRPN (figure 2 and p. 2). Zhou et al. teaches hybridization and staining (p. 2 and figure 2). Zhou et al. teaches calculation of total expression, biallelic expression and multiallelic expression based upon there microscopic images (p. 2 1st column). Figure 2 and pages 11-12 provide methods of measurement with the formula. Zhou et al. teaches using these measurements for treatment decisions (p. 11). However, Zhou et al. is focused on lung cancer and not thyroid cancer. Zhou et al. does suggest that LOI (loss of imprinting) is detected in patients with thyroid cancer.
With regard to claim 2, Zhou et al. teaches staining using hematoxylin (figure 2).
With regard to claim 3, Zhou et al. teaches measurements and classification into 5 grades (p. 12 1st column last paragraph).
With regard to claims 4-5, as provided it is not clear the expression levels needed for each grade, however, Zhou et al. teaches measurements of total, biallelic and multiallelic and classification based upon thresholds (p 5 and figures 2). As such Zhou teaches the bread of the measurement of grading.
With regard to claims 6-7, Zhou et al. teaches measurement of overall scores based upon the expression patterns of SNRPN and HM13 (figure 2 and p. 5-7).
With regard to claim 8, Zhou et al. teaches classifying in to 5 levels of increasing malignancy (pl 5 and figure 2).
With regard to claim 1, Cheng et al. teaches loss of imprinting and measurement of elves (para 20). Cheng et al. teaches imprinted genes of HM13 (para 11) and SNRPN (pare 22). Cheng et al. teaches that combinations of loss of imprint can provide treatment analysis (para 37-45).
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 Zhou et al to further determine treatment analysis of thyroid treatments as suggested both by Zhou et al. and Cheng et al. The ordinary artisan would have a reasonable expectation of success as Cheng et al. teaches that expression analysis of loss of imprinted can be used to determine treatment analysis (para 278).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of copending Application No. 18650140 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each encompass the detection and grading model of expression using HM13 and SNRPN.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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
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