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 .
Claim Status and Formal Matters
This action is in response to papers filed 4/9/2026.
Claim 8 have been amended.
Claims 1-7, 11, 15-18 and 20 have been canceled.
Applicant’s election without traverse of PGR and IRS-1, increases expression relative to control, mifepristone and RNA in the reply filed on 5/14/2024 is acknowledged.
Claim 14-16, 18.20-21 are withdrawn as the listed tables do not recite the elected gene combination.
Claim 9-10, 12-14, , 21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/24/2024.
Claims 8 and 19 are being examined.
The art rejection has been withdrawn in view of the amendment which has introduced new matter. Amending the claim to overcome the new matter rejection may necessitate re-introduction of an art rejection.
Priority
The instant application was filed 01/12/2021 and is a divisional of 15945901 , filed 04/05/2018 ,which claims priority from provisional application 62481966 , filed 04/05/2017 and claims priority from provisional application 62500694 , filed 05/03/2017.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. It is noted the examiner has not compared the IDS submitted to the references in the specification.
Claim Objections
Claims 8 and 19 are objected to because of the following informalities:
The preamble of claim 8 merely recites, “the method.” Claims are more concise when the preamble sets for the intended outcome of the claim.
Claim 8 is objected to as it recites “PR-negative” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 8 recites, “PGR, PR-negative, and PR. Claims are more concise when they provide the same limitations throughout.
Appropriate correction is required.
Response to Arguments
This is a new ground of objection.
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 8 and 19 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.
Claim 8 has been amended to recite, “determining, in a biological sample from a patient, an expression 2sample comprises PR-negative tumor tissue." Support for this amendment can be found, for example, at page 7, lines 20-24; page 10, lines 1 to 5; page 31, lines 11 to 15; and page 38, lines 31-22.” While the cited portions of the specification provide antecedent basis of “wherein the biological sample comprises PR-negative tumor tissue” The cited portions do not provide it in combination with the limitation of “wherein the expression level of the PGR, the expression level of IRS-1, or both is higher than in a control sample comprising non-cancerous tissue.” Thus the amendment appears to introduce new matter.
Further the claim no longer requires the determination of increased expression of PGR and IRS1 prior to treatment. As amended the claims require all subjects are treated with PR receptor antagonist. Review and searching of the specification did not reveal for treating all subjects with PR-antagonist regardless of expression levels.
Response to Arguments
This is a new grounds of rejection necessitated by amendment.
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 8, 19 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 8 has been amended to recite, “wherein the biological sample comprises PR-negative tumor tissue, wherein the expression level of the PGR, the expression level of IRS-1, or both is higher than in a control sample comprising non-cancerous tissue.” This recitation is confusing and unclear how a PR-negative (progesterone receptor negative) can have higher expression of progesterone receptor than non-cancerous tissue, as it appears PR-negative tumor tissue would appear to be defining the sample as being without progesterone receptor expression.
Claim 8 has been amended to recite, “determining, in a biological sample from a patient, an expression level progesterone receptor gene (PGR)2an expression level of insulin receptor substrate 1 (IRS-1), or both, wherein the biological sample comprises PR-negative tumor tissue, wherein the expression level of the PGR, the expression level of IRS-1, or both is higher than in a control sample comprising non-cancerous tissue; and administering a therapeutically effective amount of a progesterone receptor (PR) antagonist to the patient after determining the expression level.” The claim previously recited, “determining an expression sample level of one or more genes in a cell of a biological sample from a patient that is higher than an expression level of the one or more genes in a control sample comprising non-cancerous tissue.” Thus it is unclear if the claim is intended to treat all patients with PR antagonist as the literal reading requires, or if the intent is to limit treatment to only patients with higher expression of IRS12, PGR or both.
Response to Arguments
This is a new ground of rejection.
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 8 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental step without significantly. The claim(s) recite(s) the abstract idea or mental step of comparing to determine higher expression. This judicial exception is not integrated into a practical application because all patients are being treated with PR antagonist after determining expression level. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims fail to provide any specification reagents or steps which provide for significantly more. .
Claim analysis
The instant claim 8 is directed A method comprising: determining, in a biological sample from a patient, an expression level of progesterone receptor gene (PGR)2.. The comparing to determine higher expression is a mental step or abstract idea.
The determining step can be considered a mental step of reading a report..
Dependent claims set forth further limitations to PR antagonist. This is not significantly more as it does not depend on the expression levels.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract idea or mental step of comparing to determine increased expression..
This is an abstract idea or mental step.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the treatment is dependent only on having determined expression level and not the results.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No
With regards to claim 8 the claim requires a single which considered to be an active step of determining expression. The specification on page 19 teaches Illumina HT-12v4 bead chip platform according to standard protocols. Thus detection of expression is routine and conventional. Further Hung (JOURNAL OF CELLULAR PHYSIOLOGY 198:197- 208 (2004).
Response to Arguments
This is a new grounds of rejection necessitated by amendment.
Summary
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Steven Pohnert/Primary Examiner, Art Unit 1683
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