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 .
Priority
This application is a non-provisional utility application filed on 05/26/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/29/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied, and constitute the
complete set presently being applied to the instant application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: ‘step of administering’ in claim 3, ‘step of administering’ in claim 4.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 7 is 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.
Regarding claim 7, the claim limitation ‘further comprising administering a second inhibitor…not a member of the acid sensing ion channel family’ embodiments of the specification disclose inhibitor to a non-ASIC channel protein, such as a non-ASIC calcium channel. In some examples, a subject may be treated with an ASIC1a-selective inhibitor and an inhibitor of NMDA receptors, such as a glutamate antagonist [0058]. The specification reduces to practice experiments to teach PcTX1 peptide to block ASIC1a ([0107] page 32). Applicant does not reduce to practice a method of administering a second inhibitor, that inhibits a genus of non-acid sensing ion channel family. The Applicant does not provide a disclosure of the second inhibitor, that inhibits all non-acid sensing ion channels, in sufficient detail, to demonstrate to one of ordinary skill in the art that the inventor possessed the invention (see MPEP § 2181).
In the absence of an adequate written description and a reference to a potential method for practicing it, a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved. The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. "Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). See MPEP §2163.03.
Claim 1, 3, 4, 7, 8 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 administering an acid sensing ion channel 1a inhibitor, does not reasonably provide enablement for a method of treating brain cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Claim 1 is directed to a method of treating brain cancer in a tumorigenic subject. Embodiments of the specification disclose “treating” to encompass prophylactic and/or therapeutic purpose, whereby treatment reduces the likelihood of the disease or disorder [0029], reduces injury resulting from brain cancer [0047]. Thus, the scope of “treating” encompasses prevention of disease to reduction of disease progression to alleviation of symptoms of the disease. “Tumorigenic subject” as disclosed in the embodiments of the specification, is any person or animal [0048] wherein said animal includes animal with a bloodstream [0049]. The specification reduces to practice experiments to teach PcTX1 peptide to block ASIC1a ([0107] page 32), and cellular endpoints upon PcTX1 treatment [0109] [0110] [0111] [0112], in vitro. The Applicant does not reduce to practice a method of treating brain cancer in a tumorigenic subject, with the desired result of reducing injury as claimed.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether
there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement
requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5.The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the
disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands
factors are applied to claims 1, 3, 4, 7, 8 as follows:
The breadth of the claims and the nature of the invention
Claims 1, 3, 4, 7 and 8 are directed to a method of treating brain cancer in a tumorigenic subject.
The specification reduces to practice experiments to teach PcTX1 peptide to block ASIC1a ([0107] page 32), and cellular endpoints upon PcTX1 treatment [0109] [0110] [0111] [0112], in vitro i.e. administering. Embodiments of the specification disclose “treating” to encompass prophylactic and/or therapeutic purpose [0029]. The specification is not enabling for ‘treating’ to encompass prophylactic purpose. In addition, Examiner notes that the genus of brain cancer is vast, includes more than 120 different types of brain tumors (Brain Tumor Types | Johns Hopkins Medicine), requiring distinct treatment plans. Accordingly, claims 1-20 are unduly broad with respect to the scope of prevention of all brain cancers.
The State of the Prior Art
It is noted that there is no prior art that teaches prevention of all brain cancers, administering a therapeutically effective amount of an ASIC1a inhibitor.
The Level of Skill in the Art
Practitioners in this art (clinicians/pharmacologists) would presumably be highly skilled in the art for generating compositions with the prevention properties as claimed.
The Level of Predictability in the Art
It is noted that the therapeutic art it unpredictable, requiring each embodiment to be individually assessed for clinical benefit. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). This is because it is not obvious from the disclosure, of a specific method of treatment of subject for prevention of all types of brain cancer. In the instant case, the specification does not demonstrate prevention of brain cancer, in a subject, by administering an ASIC1a inhibitor. Without any experimentation demonstrating the claimed treatment, the level of unpredictability remains high. Therefore, it is unpredictable that the composition will function in the treatment method as claimed.
The amount of Direction Provided by the Inventor and The Presence or Absence of
Working Examples
The instant specification does not provide adequate guidance with regard to the
method of treatment. Applicant’s limited disclosure is noted but is not sufficient to justify claiming the composition broadly. Absent a reasonable a priori expectation of success for using ASIC1a inhibitor, one skilled in the art would have to extensively test the composition, determine an effective dose to prevent brain cancer, ascertain prevention in all brain cancer types, clinical benefit, etc. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise. The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he Level of Predictability in the Art” section supra, the specification teaches working examples with PcTX1 peptide to block ASIC1a ([0107] page 32), and cellular endpoints upon PcTX1 treatment [0109] [0110] [0111] [0112], in vitro. There is no prior art that teaches prevention of brain cancer in a subject. Also, as noted in the “Breadth of the Claims and Nature of Invention” section, the specification does not provide evidence for ‘treating’ to encompass prophylactic purpose. As such, the examples used in the specification are not indicative broadly of the method of treatment as claimed. It is further noted that Applicant provides no data, examples, figures, etc. demonstrating prevention of the genus of brain cancers by administering the ASIC1a inhibitor. In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that,
based on the evidence regarding each of the above factors, the specification, at the time the application
was filed, would not have taught one skilled in the art how to make and/or use the full scope of the
claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d
1510,1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claims 1, 3, 4, 7, 8, in view of the Applicant’s
entire disclosure, it is concluded that the practice of the invention as claimed in claims 1, 3, 4, 7, 8, would not be enabled by the written disclosure for treatment of brain cancer. Therefore claims 1, 3, 4, 7, 8, are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to treat a subject as claimed.
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 4 is 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.
Regarding claim 4, the term “a peptide” gives rise to two interpretations -either that the peptide is in addition to the peptide administered in claim 1, or that the peptide refers to the peptide of claim 1, comprising a cysteine knot. Since an artisan of ordinary skill would be unable to ascertain the metes and bounds of the claim scope, ambiguity arises.
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.
Claim 4 is 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 claim recites ‘a peptide that includes a cysteine knot’ which is not further limiting, if the claim is referring to the peptides in claim 1 (see interpretation in the rejection under 35 U.S.C. 112(b)). Examiner notes, that embodiments of the specification disclose cystine knot, as comprising an arrangement of six or more cysteines ([0060], line 3). 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 § 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.
Claims 1, 3, 4, 7 and 8 is/are rejected under 35 U.S.C. 103 as being obvious over Benos et al, hereinafter Benos (US2007/0092444A1, published 26 April 2007) in view of Roger P. Simon et al., hereinafter Simon (U.S. Patent No.US8030442B2; EFD: Nov 20, 2007).
The applied reference has a common Applicant and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Benos teaches methods of treating glial-derived tumors such as gliomas [0034]. Benos teaches that glial-derived tumors are primary brain tumors, astrocytomas, glioblastomas, or oligodendrocytomas [0035]. Benos teaches administering to a subject in need of such treatment, a therapeutically effective amount of a pharmaceutical composition containing a compound that inhibits the activity of the Na+ channel [0039]. Benos teaches, that the inhibition occurs by blocking the activity of the ASIC component, such as an ASIC1 component ([0039] line 15; [0054 line 10). Benos teaches PcTX1 (Psalmatoxin), or a variant of PcTX1 [0039]. Benos teaches variants of PcTX1 that retain the activity of the peptide; variants differ in amino acid sequence by one or more substitutions, additions, deletions in any combination (see [0042] line 15).
The variants in Benos, encompasses the instantly claimed SEQ ID NO: 2-5. Benos does not list the instantly claimed SEQ ID NO: 2-5.
Simon teaches SEQ ID NO: 2-5 (see Fig 11 in Simon). In the sequence alignments noted below, ‘Qy’ refers to the instant sequence and Db refers to the sequence in Simon for SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4 and SEQ ID NO: 5 respectively. Note that the sequences in Simon, share 100 % sequence identity with the instantly claimed sequences.
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Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer variants of PcTX1, as specifically suggested in Benos. One motivated to do so, would have a reasonable expectation of success, as Simon specifically teaches PcTX1 and PcTX1 variants for the inhibition of the acid sensing ion channel (see Fig 11; claim 1). Thus, one would have recognized that applying the teaching of Benos to the teachings of Simon would have yielded predictable results, as Benos teaches PcTX1 variants in the treatment of brain cancer via ASIC1a inhibition, and Simons specifically generates SEQ ID NO: 2-5, for inhibition of the acid sensing ion channel (See MPEP §2143).
Regarding claim 3, the combined teachings of Benos and Simon and the obviousness rationale has been set forth above.
Regarding claim 4, Examiner interprets the limitation ‘a peptide’ as the peptides of claim 1. Additionally, embodiments of the specification disclose cystine knot, as comprising an arrangement of six or more cysteines ([0060], line 3). SEQ ID NO: 2-5 comprise an arrangement of six or more cysteines.
Regarding claim 7, Benos teaches the method of treating, that involves administering to a subject a compound linked to a cytotoxic agent or inhibitors of tumor growth ([0040] see lines 10-12). Compounds maybe employed alone or with other compounds (see[0043] line 15). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer variants of PcTX1 and second inhibitor, as specifically suggested in Benos. One motivated to do so, would have a reasonable expectation of success, as Benos teaches that PcTX1 may be a candidate therapeutic agent, either alone or in combination with other drugs, for the treatment of tumors expressing the constitutive inward Na+ currents [0089]. (See MPEP §2143).
Regarding claim 8, Benos teaches that PcTX1 inhibited inward currents mediated by ASIC1a and not the inward Na+ currents mediated by ASIC2 [0081], Fig 20. Benos also teaches in Fig 8A and Fig 8B, amiloride-sensitive inward Na+ currents (at -60 mV) in cells expressing either ASIC1 or ASIC2 at pH 4.0. Inward peak (Ip) was greatest for ASIC1a and least for ASIC2. Inhibitory concentration is 400 µM amiloride [0065]. Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer variants of PcTX1, suggested in Benos and specifically disclosed in Simon, at concentrations that are used in Benos. One motivated to do so, would have a reasonable expectation of success, as Benos teaches treatment of brain cancer using ASIC1a inhibitors (See MPEP §2143).
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.
1. Claims 1, 3, 4, 7, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No.US8030442B2 in view of Benos et al, hereinafter Benos (US2007/0092444A1, published 26 April 2007), further in view of Mrinal K. Ghosh et al., hereinafter Ghosh (Ghosh, M.K., Chakraborty, D., Sarkar, S. et al. The interrelationship between cerebral ischemic stroke and glioma: a comprehensive study of recent reports. Sig Transduct Target Ther 4, 42 (2019)). Although the claims at issue are not identical, they are not patentably distinct from each other.
The teachings of Benos and Simon have been set forth above.
Regarding claim 1, reference patent ‘442, teaches a method of treating brain injury comprising administering an acid sensing ion channel peptide inhibitor (see claims 1-6 in the reference patent). Reference patent specification discloses treating to encompass “treating” or “preventing” (see column 7). Reference patent does not treat brain cancer.
Ghosh teaches clinical reports and case studies that indicate glioblastoma, with a mortality rate that is threefold higher in postischemic patients, compared to control cohort (see section: Interplay between cerebral ischemia and glioma: what do clinical reports reveal; see Fig 1 and Fig 2). Ghosh teaches that several drugs are commonly used to treat both glioma and ischemia due to the counteracting effect on common signaling pathways shared by these conditions (see Fig 4; see section Therapeutic approaches for ischemia and glioma).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer an acid sensing ion channel peptide inhibitor for treating ischemic brain injury as taught by the reference patent (U.S. Patent No.US8030442B2) and modify it to treat brain cancer in a tumorigenic subject as taught by Ghosh.
One motivated to do so would have a reasonable expectation of success, as Ghosh teaches common signaling pathways in glioma and ischemia and their treatment to counteract the effect of common signaling pathways using drugs sanguinarine, glycyrrhizin, piroxicam, salidroside, astragaloside, hyperbaric oxygen therapy, etc. (see Fig 4; see section Therapeutic approaches for ischemia and glioma). Thus, one would have recognized that applying the teaching of the reference patent to the teachings of Ghosh would have yielded predictable results and improved the ability of acid sensing ion channel peptide inhibitor in the treatment of brain cancer (See MPEP §2143).
Regarding claim 3, the obviousness rationale has been set forth above. Reference patent ‘442 specifically teaches SEQ ID NO: 2-5 as noted.
Regarding claim 4, reference patent ‘442 teaches SEQ ID NO: 2-5 as instantly claimed.
Regarding claim 7, reference patent ‘442 teaches a second therapeutic agent (see claim 11). As noted, per the obviousness analysis of claim 1, the method can be practiced in a tumorigenic subject, to treat brain cancer.
Regarding claim 8, reference patent ‘442 teaches ASIC1a inhibition (see claim 1).
2. Claims 1, 3, 4, 7, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No.US10717771B2 in view of Benos et al, hereinafter Benos (US2007/0092444A1, published 26 April 2007), further in view of Mrinal K. Ghosh et al., hereinafter Ghosh (Ghosh, M.K., Chakraborty, D., Sarkar, S. et al. The interrelationship between cerebral ischemic stroke and glioma: a comprehensive study of recent reports. Sig Transduct Target Ther 4, 42 (2019)). Although the claims at issue are not identical, they are not patentably distinct from each other.
The teachings of Benos and Simon have been set forth above.
Regarding claim 1, reference patent ‘771, teaches a method of treating ischemia comprising administering SEQ ID NO: 1-5 (see claims 1-7 in the reference patent). SEQ ID NO: 2-5 in the reference patent is 100 % identical to the instantly claimed SEQ ID NO: 2-5.
Ghosh teaches clinical reports and case studies that indicate glioblastoma, with a mortality rate that is threefold higher in postischemic patients, compared to control cohort (see section: Interplay between cerebral ischemia and glioma: what do clinical reports reveal; see Fig 1 and Fig 2). Ghosh teaches that several drugs are commonly used to treat both glioma and ischemia due to the counteracting effect on common signaling pathways shared by these conditions (see Fig 4; see section Therapeutic approaches for ischemia and glioma).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer SEQ ID NO: 2-5 as taught by the reference patent ‘771 and modify it to treat brain cancer in a tumorigenic subject as taught by Ghosh.
One motivated to do so would have a reasonable expectation of success, as Ghosh teaches common signaling pathways in glioma and ischemia and their treatment to counteract the effect of common signaling pathways using drugs sanguinarine, glycyrrhizin, piroxicam, salidroside, astragaloside, hyperbaric oxygen therapy, etc. (see Fig 4; see section Therapeutic approaches for ischemia and glioma). Thus, one would have recognized that applying the teaching of the reference patent ‘771 to the teachings of Ghosh would have yielded predictable results and improved the ability of acid sensing ion channel peptide inhibitor in the treatment of brain cancer (See MPEP §2143).
Regarding claim 3, the obviousness rationale has been set forth above. Reference patent ‘771 specifically teaches SEQ ID NO: 2-5 as noted.
Regarding claim 4, reference patent ‘771 teaches SEQ ID NO: 2-5 as instantly claimed.
Regarding claim 7, reference patent ‘771 does not teach a second therapeutic agent (see claim 11). As noted, per the obviousness analysis of claim 1, the method can be practiced in a tumorigenic subject, to treat brain cancer using a second inhibitor as suggested in Benos.
Regarding claim 8, reference patent ‘771 teaches ASIC1a inhibition (see claim 1).
3. Claims 1, 3, 4, 7, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No.US10336796B2 in view of Benos et al, hereinafter Benos (US2007/0092444A1, published 26 April 2007), further in view of Mrinal K. Ghosh et al., hereinafter Ghosh (Ghosh, M.K., Chakraborty, D., Sarkar, S. et al. The interrelationship between cerebral ischemic stroke and glioma: a comprehensive study of recent reports. Sig Transduct Target Ther 4, 42 (2019)). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding independent claim 1, reference patent ‘796 teaches SEQ ID NO: 2-5 that is 100 % identical to the instantly claimed sequences (see claims 1-10). Additionally, the obviousness rationale as set forth above, in the method of treatment of brain cancer, read on claims 1, 3, 4, 7 and 8.
Conclusion
No claim is allowed
Correspondence
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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