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
Filing Receipt
The filing receipt mailed 05/13/2024 states that the instant application is a 371 of PCT/EP2022/067318, filed 06/24/2022, which claims benefit of EPO 21181444.7, filed 06/24/2021, and EPO 21204648.6, filed 10/26/2021.
The instant claims find support in the EPO 21181444.7 document. Therefore, the effective filing date is 06/24/2021.
Information Disclosure Statement
The information disclosure statement submitted 01/19/2024 has been considered.
Objections
Claims 25 and 26 are objected to as they lack “to” in the phrase “according claim 13”.
Rejections
Claim Rejections - 35 USC § 112(a)
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.
Claim 26 is 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 HIV infections, does not reasonably provide enablement for all viral infections. 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 following Wands factors have been considered (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the claims
Claim 26 states “A method for treating a viral infection in a subject….”.
“Viral” is not explicitly defined. Examples of “viral infections” within the specification are limited to retroviral and lentiviral (p. 4, l. 27). Other than this, the instant specification on p. 1, l. 3-4 states “The invention relates to isoquinoline and pyridine based CXCR4 antagonists and their use in the treatment and prevention of viral infections.”
Nature of the invention
The invention is to a clinical method of treating viral infection.
State of the prior art
Examples of similar compounds, including one compound that directly embraces the claims, are disclosed in Denath (Theranostics, 2013, Vol. 3, Iss. I, of the record). Debnath discloses a compound 88, on p. 62, Figure 13.
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Note that the caption of Figure 13 indicates that the compounds display anti-HIV activity. However, Denath indicates that the compounds are, in general, CXCR4 antagonists.
Denath discusses a number of other conditions including Cancer, Rheumatoid Arthritis, WHIM syndrome, Ischemic Injury, Pulmonary Fibrosis, and Lupus. However, there is no discussion of other viruses which the compounds have shown efficacy against.
Working Examples and Guidance
The instant specification discloses anti-HIV efficacy of the instant compounds in Table 1.
However, the instant specification does not discuss other viral infections nor does it discuss if CXCR4 inhibition can be effective against other viral infections.
Level of Predictability
Considering above, the instant disclosure is enabled by evidence and the prior art such that one of ordinary skill would be able to practice the claim method towards HIV with a reasonable assumption of success.
However, there is a significant level of unpredictability against other viral infections.
Claim Rejections - 35 USC § 112(b)
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.
Method without therapeutic amount
Claims 25 and 26 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 25 states “A method for medicating a subject, the method comprising administering to the subject the compound according [to] claim 13.”
Claim 26 states “A method for treating a viral infection in a subject, the method comprising administering to the subject the compound according [to] claim 13”.
Both claims are drawn to a method of administering a compound for treatment without specifying a therapeutic amount.
The claims are indefinite because, without stating “a therapeutic amount”, the claim encompasses ineffective amounts of the compound. As the methods are for treatment or medicating, a specific amount that causes a positive effect is required.
Indefinite
Claims 25 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 25 is rejected over the use of the term “medicating”. “Medicating” is not defined in the instant specification. The broadest reasonable interpretation of the term “medicating” is simply “administering a drug”. With this interpretation, the claim would mean “A method of administering a drug comprising administering to the subject a compound…”.
Without an explicit definition of the term “medicating”, the claim is ambiguous and one of ordinary skill in the art would not know the metes and bounds of the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13-24 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bridger (US2004/0209921, of the record).
Bridger on p. 55, para. [0535] discloses compound Example 100.
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Claim(s) 13-30 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Skerlj (Bioorganic & Medicinal Chemistry Letters, 21, (2011) 1414-1418, of the record) in view of Skerlj (J. Med Chem. 2010, 53, 3376-3388, herein after Skerlj 2010).
Skerlj on p. 1415, Table 1 discloses compounds having anti-HIV-1 activity.
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Regarding claim 30, compound 2a of Skerlj embraces the compounds claimed in claims 13-24. Skerlj points to Skerlj 2010 for the assay conditions which the results are disclosed in the above table. Skerlj 2010 on p. 3386, sec. 125I-Chemokine Competition Binding Assay discloses assay conditions involving dissolving compounds in phosphate buffered saline, a pharmaceutically acceptable carrier. These same conditions are purportedly used in Skerlj.
Regarding claims 24-29, Skerlj on p. 1417, right col., para. 1 states “”In summary we identified a novel series of small molecule antagonists based on the redesign of AMD070. These molecules are antagonists of the chemokine receptor CXCR4 based on inhibition of SDF-1 induced calcium signaling and 125I-SDF-1 binding and are potent inhibitors of HIB-1 replication. Based on encouraging ADME data and pharmacokinetic data these compounds further advanced to rodent toxicology studies.”
Claim(s) 13, ad 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (RN Entry 2156451-35-1, dated 12 Dec. 2017).
STN discloses a compound, shown below, which embraces the limitations of the claims.
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Claim Rejections - 35 USC § 103
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 13-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bridger (US2004/0209921, of the record) in view of Skerlj (Bioorganic & Medicinal Chemistry Letters, 21, (2011) 1414-1418, of the record.
Discussion of Bridger from the 102 rejection above is incorporated here.
Regarding claims 24-28, Bridger in para. [0044] contemplates pharmaceutical compositions where it states “The invention includes pharmaceutical compositions comprising a therapeutically effective amount of a compound of Formula 1 along with at least one excipient, and methods of treating diseases o the human body or the bodies of other mammals with such compositions.”
Bridger in para [0071] contemplates embodiments wherein “the invention provides compounds of Formula 1 that demonstrate protective effects on target cells from HIV infection by binding specifically to the chemokine receptor thus affecting the binding of a natural ligand to the CCR4 and/or CXCR4 of a target cell.”
Where Bridger contemplated administration, Bridger does not does not directly teach administering to treat HIV or to medicate. Skerlj where, on p. 1415, Table 1, teaches compound 2a (identical to example 100 of Bridger) is effective against HIV-1, having an IC50 of 15.3 nM.
Bridger teaches the compound and contemplates administration of said compound. Skerlj teaches efficacy of the compound against HIV-1.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have taken the compound of Bridger and Skerlj and use it in methods to treat HIV or medicate with a reasonable assumption of success. One of ordinary skill would find motivation in Skerlj which teaches that the compound is has efficacy as an anti-HIV compound.
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.
US Patent 7,863,293
Claims 13-24 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 7,863,293.
The references claims are drawn to compounds of formula shown below and compositions comprising said compounds.
Formula I
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The reference patent in col. 96 also teaches the following compound labeled Example 100.
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The compound is specifically claimed within claim 21. The reference patent also claims pharmaceutical compositions in claims 22-25.
US Patent 7,291,631
Claims 13-24 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 7,291,631.
The reference patent discloses a compound labeled Example 100 (identical to that of the ‘293 patent above) in col. 98. The compound is claimed in ref. claim 21. Reference claims 22-25 claim pharmaceutical compositions comprising the compounds.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624