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 .
DETAILED ACTION
Claims 1-13 are pending in the instant application.
Claims 1-13 are being examined herewith.
Priority
The instant application is a Continuation of U.S. Patent Application 17/031,642, filed on 24 September 2020, now abandoned, which claims priority from U.S. Provisional Patent Application 62/905,134, filed on 24 September 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 September 2024 is acknowledged and considered.
Objection to the Specification The Specification is objected to because on page 5, [0009], it contains typographical errors “2-hydroyxbenzylamine” should read --2-hydroxybenzylamine--. The same applies for the other two compounds listed.
Claim Objection
Claim 3 is objected to because it contains typographical errors “2-hydroyxbenzylamine” should read --2-hydroxybenzylamine--. The same applies for the other two compounds listed.
Claim 13 is objected to because the recitation “another active agent that had a known side effect of treating lupus” is confusing. It is unclear whether said another active agent is known to treat lupus and to also have side effects, or rather the active agent is effective to treat another disease and its side effect is that it also treats lupus? Appropriate clarification of the claim language is required.
In the interest of compact prosecution, the examiner interprets claim 13 to be drawn to the method of claim 1, wherein the compound […] is co-administered with another active agent effective to treat lupus wherein said active agent has a known side effect.
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 5, 6 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 5 depends on claim 1 and recites
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; yet claim 1 defines substituent R2
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as
H, or substituted or unsubstituted alkyl. As such, there is insufficient antecedent basis for
R2 = -OCH3 in the compounds of claim 5 above, in claim 1.
Appropriate correction is required.
Claim 6 is rejected because substituent (second structure in claim 6) on the phenyl ring that reads C3HO- should read H3CO-.
Appropriate correction is required.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al. (US 2014/0256774, published 11 September 2014, cited in PTO-892).
Roberts teaches (US2014/0256774) a method of treating an inflammatory autoimmune response such as, for example, systemic lupus erythematosus (claim 10, [0127]), which is a subtype of lupus of instant claim 7, by administering to a patient in need thereof a scavenger of g-ketoaldehydes [0042] of the following formula ([0049]-[0050], page 5)
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.
The genus of compounds above taught by Roberts (R is C) overlaps with/ encompasses all compounds of the instant claims.
Roberts specifically teaches
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salicylamine [0104], which is a compound of instant claims 3, 4, 5, as a compound of the invention. Roberts teaches [0133] that salicylamine is 980 times more reactive than lysine with g-ketoaldehydes.
Roberts specifically teaches [0104] the following compounds
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, which are the very compounds of instant claim 5.
Roberts specifically teaches [0105] the following compounds:
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, which are the very compounds of instant claim 6.
Roberts specifically teaches [0106] the following compounds:
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, which are compounds of instant claim 4.
Roberts teaches that the compounds of the invention are scavengers of g-ketoaldehydes [0042], which prevent said g-ketoaldehydes (g-KAs) from adducting top lysine residues on proteins.
Roberts teaches [0032] that g-KAs are highly reactive and remarkably injurious molecules; they almost instantaneously adduct specifically to lysine residues on proteins, and rapidly induce cross-linking of proteins [0033]. Roberts teaches that g-KAs are pro-inflammatory ([0034]-[0035]). Roberts teaches [0149] that the compounds of the invention intercept g-KA formed via isoprostane pathway of lipid oxidation, thereby preventing their adduction to proteins.
Thus, Roberts teaches that the compounds of the invention, including salicylamine and compounds of instant claims 3-6, can be used as scavengers of g-ketoaldehydes to treat diseases in which levels of g-ketoaldehydes are increased.
Roberts teaches [0123] administration of a composition comprising a compound of the invention and a pharmaceutically acceptable carrier, as in instant claim 12, to treat an inflammatory disease such as, for example, systemic lupus erythematosus ([0127], also claim 10).
Roberts teaches [0124] that a compound of the invention is administered to the patient in an amount sufficient to reduce of inhibit the desired indication, which is consistent with inhibiting progression of disease, as in instant claim 8, or attenuating the severity of disease, as in instant claim 9, or mitigating damaging effects of the disease in the patient, as in instant claims 10, 11.
Roberts does not teach a method of treating lupus with a compound above, where the compound is co-administered with another active agent that has a known side effect of treating lupus, as in instant claim 13.
It would have been obvious to use a compound disclosed by Roberts, such as salicylamine, or the specific compounds in [0104]-[0106], to treat lupus or a type of lupus which is systemic lupus erythematosus. The person of ordinary skill in the art would have used salicylamine or any other compound disclosed by Roberts in a method of treating lupus, because Roberts teaches that the compounds of the invention can be used as antioxidant scavengers of g-ketoaldehydes to treat an inflammatory disease such as, for example, systemic lupus erythematosus. Thus, the person of ordinary skill in the art would have administered salicylamine or any other compound disclosed by Roberts to a patient suffering from lupus, with the expectation that administration of said compound will result in therapeutic effect, including inhibiting the progression of lupus, attenuating the severity of lupus, or mitigating the damaging effects of lupus in the patient.
With regard to claim 13, the person of ordinary skill in the art would have been motivated to co-administer a compound taught by Roberts with another active agent effective to treat lupus, to patients suffering from lupus, because each of the two agents for co-administration are known to be effective to treat lupus. Since all compounds for co-administration herein are known to be useful to treat lupus, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
As such, instant claims 1-13 are rejected as prima facie obvious.
Statutory Double Patenting
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.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-4, 7-10, 12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4, 6-10 of copending Application No. 18/917,759 (reference application, cited in PTO-892). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Nonstatutory 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, 5, 6, 10, 11, 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1, 5 of co-pending Application No. 18/917,759 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 5 of co-pending Application No. 18/917,759 anticipate or render obvious the instant claims.
Claim 1 of co-pending Application No. 18/917,759 is drawn to a method of treating lupus with a genus which encompasses the very same compounds as in instant claim 1. Claim 5 of co-pending Application No. 18/917,759 recites 2-hydroxybelzylamine, which is a compound of instant claims 5, 6. Claim 9 recites that treating mitigates damaging effect of lupus, as in instant claim 10.
It would have been obvious to use a compound from the genus of claims 1, 5 of co-pending Application No. 18/917,759, to treat lupus and the damaging effects of lupus in the subject. The person of ordinary skill in the art would have used a compound from the genus of claims 1, 5 of co-pending Application No. 18/917,759 in a method of treating lupus, with the expectation that said compound is effective to mitigate abnormal sodium excretion as damaging effect of lupus, as in instant claim 11. With regard to claim 13, the person of ordinary skill in the art would have been motivated to co-administer a compound taught by claims 1, 5 of co-pending Application No. 18/917,759 with another active agent effective to treat lupus, to patients suffering from lupus, because each of the two agents for co-administration are known to be effective to treat lupus. Since all compounds for co-administration herein are known to be useful to treat lupus, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-9 of co-pending Application No. 18/917,789 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-9 of co-pending Application No. 18/917,789 render obvious the instant claims.
Claims 1-9 of co-pending Application No. 18/917,789 are drawn to a method of treating or ameliorating an inflammatory autoimmune response comprising administering to a patient in need thereof a compound of the formula
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, wherein
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; the genus is encompassed by encompasses the compounds of instant claim 1; claim 2 recites the very compounds in instant claim 3; claim 3 recites 2-hydroxybenzylamine, which is a compound of instant claims 3-5. The Specification of co-pending Application No. 18/917,789 recites systemic lupus erythematosis [0107] as one of the inflammatory autoimmune responses/autoimmune diseases to be treated.
It would have been obvious to use a compound from the genus of claims 1-9 of co-pending Application No. 18/917,789, such as salicylamine, or the specific compounds in claims 3-6 of co-pending Application No. 18/917,789, to treat lupus or a type of lupus which is systemic lupus erythematosus. The person of ordinary skill in the art would have used a compound from the genus of claims 1-9 of co-pending Application No. 18/917,789, in a method of treating lupus, because claims 1-9 of co-pending Application No. 18/917,789 teach that the compounds of the invention are effective in a method of treating an inflammatory immune response, and the Specification of co-pending Application No. 18/917,789 recites systemic lupus erythematosis as one of the inflammatory autoimmune responses/autoimmune diseases to be treated. Thus, the person of ordinary skill in the art would have administered a compound from the genus of claims 1-9 of co-pending Application No. 18/917,789, to a patient suffering from lupus, with the expectation that administration of said compound will result in therapeutic effect, treating lupus in the patient.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 7-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,975,033 (cited in PTO-892), in view of Roberts et al. (US 2014/0256774, published 11 September 2014, cited in PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of U.S. Patent No. 10,975,033 render obvious the instant claims.
Claims 1-5 of U.S. Patent No. 10,975,033 are drawn to a method of treating or ameliorating an isoprostane induced inflammatory autoimmune response, comprising administering a gamma-ketoaldehyde scavenging effective amount to a patient in need thereof a compound which is 2-hydroxybenzyl amine, wherein the inflammatory autoimmune response includes at least one of hypertension, psoriasis or edema.
Roberts et al. (US 2014/0256774, published 11 September 2014, cited in PTO-892) teaches that 2-hydroxybenzylamine (synonym salicylamine) is a scavenger of g-ketoaldehydes [0042] effective to treat an inflammatory autoimmune response such as, for example, systemic lupus erythematosus (claim 10, [0127]), hypertension ([0045], [0047], [0048], [0148], Example 5), psoriasis [0127], [0048] or edema (Examples 1, 2, Figure 6, 7).
It would have been obvious to use salicylamine to treat lupus or a type of lupus which is systemic lupus erythematosus. The person of ordinary skill in the art would have administered salicylamine (synonym 2-hydroxybenzyl amine) in a method of treating lupus, because claims 1-5 of U.S. Patent No. 10,975,033 teach that salicylamine is effective to treat an isoprostane induced inflammatory autoimmune response, such as hypertension, psoriasis or edema, and Roberts teaches that 2-hydroxybenzylamine is a scavenger of g-ketoaldehydes effective to treat an inflammatory autoimmune response such as, for example, systemic lupus erythematosus, hypertension, psoriasis or edema. Thus, the person of ordinary skill in the art would have administered salicylamine to a patient suffering from lupus, with the expectation that administration of said compound will result in therapeutic effect.
Conclusion
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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