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 without traverse of Group I, claims 3-4, 6-11, 13-15, 19-20, in the reply filed on 02/11/2026 is acknowledged.
Claims 25, 27, 34, 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
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 3-4, 6-11, 13-15, 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for identifying the subject with breast cancer likely to be responsive to treatment, does not reasonably provide enablement for identifying the subject with any cancer likely to be responsive to treatment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are broadly drawn to methods of identifying a subject with cancer who is likely to be responsive to treatment with a modulator of the HER signalling pathway, wherein the method comprises; a) providing a sample of the subject; b) detecting the level of expression of EGR4-S in the sample of the subject, and c) identifying the subject as being likely to be responsive to treatment with the modulator of the HER signalling pathway if EGR4-S expression is at or above a predetermined level in the sample of the subject, and wherein the subject is likely to be resistant to treatment with the modulator of the HER signalling pathway if EGR4-S expression is at or below a predetermined level in the sample of the subject, such cancer can be solid, lung or breast cancer.
Claims encompass identifying responsiveness to treatment of a subject with any kind of cancer based on expression of EGR4-S.
Instant specification though teaches EGR4-S as an important biomarker in only one type of cancer, breast cancer (see Examples 2-14). Specification does not provide any evidence that EGR4-S in relevant in any other types of solid cancer, including lung cancer.
There is no prior art teaching EGR4-S as a biomarker in any type of cancer.
Instant disclosure fails to provide guidance on relevance of EGR4-S biomarker to any other type of cancer than breast cancer.
The guidance provided in the specification relates only to breast cancer and fails to address the relevance of EGR4-S to any other types of cancer.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to identify a subject with any cancer who is likely to be responsive to treatment as instantly claimed. Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
Claims 3-4, 6-11, 14-15, 19-20 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.
Claims are broadly drawn to methods of identifying a subject with cancer who is likely to be responsive to treatment with a modulator of the HER signalling pathway, wherein the method comprises; a) providing a sample of the subject; b) detecting the level of expression of EGR4-S in the sample of the subject, and c) identifying the subject as being likely to be responsive to treatment with the modulator of the HER signalling pathway if EGR4-S expression is at or above a predetermined level in the sample of the subject and administering such modulator to a subject, and wherein the subject is likely to be resistant to treatment with the modulator of the HER signalling pathway if EGR4-S expression is at or below a predetermined level in the sample of the subject, such modulator of the HER signalling pathway can be EGFR inhibitor.
Claims encompass identifying subjects responsive to treatment with modulators of the HER signalling pathway and actual treatment with such modulators.
Instant specification defines modulator of the HER signalling pathway as an agent that modulates an activity of a HER signalling pathway. The term includes small molecules, antibodies, antigen binding fragments thereof, immunoadhesins, fusion proteins, oligopeptides and other molecules that decrease, block, inhibit, abrogate or interfere with signal transduction resulting from the interaction of the molecules of the HER family, including siRNA, shRNA and other interfering RNA (see paragraph [0087]). Thus, the genus of such modulators is extremely wide and varied and includes compounds of many chemical structures and different ways of activity. Further specification teaches that such modulators include molecules that decrease, block, inhibit, abrogate or interfere with signal transduction resulting from the interaction of a member of the HER family with one or more of its binding partners (see paragraph [0092]). It is notable that the language states that modulators include such molecules, but are not limited to those. Therefore, the genus of modulators can include molecules providing activation of signal transduction instead of inhibition.
Specification provides an example of modulator of the HER signalling pathway as EGFR inhibitor (see paragraph [0055]), specifically lapatinib, gefitinib and erlotinib (see paragraph [0162], Example 3). Specification further teaches that such modulators can include tyrosine kinase inhibitors and HSP90 inhibitors (see paragraph [0070]).
Thus, the genus of modulators of the HER signalling pathway encompasses a large number of varied structures and one of skilled in the art cannot reliably predict which member of the genus would successfully treat cancer, and which will not.
There is no description of the necessary and sufficient elements of the species encompassed by the breadth of the claims.
The only species described in specification are EGFR inhibitors. Applicant fails to describe representative members of Applicant's broadly claimed genus.
One of the skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, EGFR inhibitors are not sufficient to describe the claimed genus. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
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 3-4, 6, 9, 13-15, 19-20 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.
Claim 3 recites methods of identification of a subject with cancer likely to be responsive to treatment by measuring level of expression of EGR4-S and comparing in to a control further identifying if the subject is expected to be responsive to treatment if the level of EGR4-S is at or above a predetermined level and subject is expected to be not responsive if the level is at or below a predetermined level (emphasis added). If such predetermined level is the same in both cases and the level of EGR4-S is determined to be at that level, it is impossible to decide if the subject is going to be responsive or unresponsive to treatment.
Claims 4, 6, 9, 13-15, 19-20 are rejected based on their dependency on claim 3.
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 3, 6-11, 13-15, 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to law of nature without significantly more.
The claim(s) recite(s) methods of identifying a subject with cancer who is likely to be responsive to treatment with a modulator of the HER signalling pathway, wherein the method comprises; a) providing a sample of the subject; b) detecting the level of expression of EGR4-S in the sample of the subject, and c) identifying the subject as being likely to be responsive to treatment with the modulator of the HER signalling pathway if EGR4-S expression is at or above a predetermined level in the sample of the subject, and wherein the subject is likely to be resistant to treatment with the modulator of the HER signalling pathway if EGR4-S expression is at or below a predetermined level in the sample of the subject.
The claims recite a number of steps of identifying subject susceptible to treatment, therefore satisfying Step 1 of eligibility analysis, because the claims are drawn to the process. A process is a statutory category of invention.
Step 2A, Prong One of eligibility analysis evaluates whether the claim recites a judicial exception. Steps b and c of instantly claimed method relate the level of EGR4-S expression to susceptibility of a subject to treatment. Such relation is naturally present in the subject with cancer, therefore the claims do recite a judicial exception, law of nature.
Step 2A, Prong Two of eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. Instant claims simply recite determination if the subject is susceptible to treatment and nothing more. Thus, the judicial exception is not integrated into any practical application.
Step 2B of eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. Independent claim 3 does not have any additional elements except for exception itself. Dependent claims add additional measurements to make determination, define ways to detect expression of EGR4-S or further define cancer to be evaluated. None of those add an inventive concept to the claims.
Thus, claims are not 35 U.S.C. 101 eligible.
Allowable Subject Matter
There is no prior art teaching EGR4-S biomarker by itself or in relation to cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637