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 .
Status of the Claims
Currently, claims 1-17 are pending in the instant application.
Priority
The instant application claims priority to provisional application 63/508,038, filed on 06/14/2023.
Claim Objections
Claim 3 is objected to because of the following informalities: Grammatical error. The instant claim recites a “pharmaceutical composition comprising the follow molecular structure” (underlined for emphasis). The word “follow” should be changed to “following”. Appropriate correction is required.
Claims 4-5, and 7, 9-10, and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112 – Second Paragraph
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 1-17 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.
Each of claims 1-3 and 6 are indefinite for reciting the limitation “A = Any Atom Not Hydrogen” because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claims. The current recitation of the claim is unclear because a person of ordinary skill in the art would not reasonably be able to determine whether the compound being claimed terminates in a non-hydrogen atom (for example, a halogen having valency of 1), or extends to further moieties in cases where the non-hydrogen atom is an atom with valency greater than 1 (i.e., C, O, N, etc.). As the aforementioned recitation may encompass any number of unspecified moieties, the bounds of the claim are not readily understandable.
Each of claims 3-17 are each indefinite for reciting a composition “comprising” or “having” a molecular structure, because a person of ordinary skill in the art would not reasonably understand the metes and bounds of the claim. The instant claims are directed towards pharmaceutical compositions, which a chemical structure would not necessarily be applicable to. This rejection may be overcome by appropriately re-wording the claims to clarify that the claimed pharmaceutical compositions comprise a compound of the recited structure (i.e., “A pharmaceutical composition comprising a compound of the following structure” and/or “The pharmaceutical composition of claim X, wherein the compound has the following structure”).
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) 1 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah (Bioorganic & Medicinal Chemistry 17 (2009) 5325–5331).
Claim 1 recites a method of treating malaria, wherein the method comprises administering a pharmaceutical composition comprising a compound of the following structure:
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Shah teaches artemisinin derivatives as compounds having antimalarial activity. More specifically, Shah administers said derivatives to malaria parasitized red blood cells (RBC) in order to ascertain uptake profiles of the compounds (Abstract)1. Of particular relevance to the instant claim is the following compound 17 (Fig. 1, page 5327):
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The above compound is a compound of the recited formula wherein:
X is O and N
Y is O
n is 0
A is carbon (i.e., a non-hydrogen atom)
Shah further indicates that parasitized RBCs were dosed with a solution comprising saline and artemisinin derivatives (page 5326)2. As Shah teaches the compound of the instant claim, a composition comprising said compound, the utility of the compound as an antimalarial, and the administration of the compound to infected RBCs, the teaching of Shah meet the limitations of the instant claim.
Claim 3 recites a pharmaceutical composition comprising a compound of the following structure:
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The recited structure appears to be identical to the compound structure recited in claim 1. As iterated in the rejection of claim 1, Shah teaches a compound of the recited structure (i.e., compound 17), and a composition wherein said compound is combined with saline.
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.
Claim(s) 2, 6, 8, 11-12, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah (previously referenced).
Claim 2 recites a method of treating malaria comprising administering a compound of the following molecular structure:
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Shah teaches compounds as artemisinin derivatives having antimalarial activity. Of particular significance to the instant claim are compounds 7, 8, and 17 (Fig. 1, page 5327):
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While Shah does not explicitly teach an individual compound meeting the limitations of the recited structure, it would have been obvious to arrive at a compound of the instant claim because Shah teaches individual moieties of the recited compound, and there would be a reasonable expectation that such a compound would be effective as an antimalarial.
Shah indicates that artemisinin and artemisinin derivatives are an established class of drugs with antimalarial properties (page 5325)3. As iterated above, the most relevant compounds of Shah in regards to the instant claim are compounds 7, 8, and 17. Compounds 7 and 8 provide an artemisinin based fused ring moiety which corresponds to the ring (and accompanying limitations) of the instantly recited structure. Compound 17 provides a moiety corresponding to the amino carbonyl group of the structure of the instant claim.
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By combining the main artemisinin ring of compounds 7 and 8 with the C7 substitution of claim 17, a person of ordinary skill in the art could arrive at a final compound having the following structure:
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Given the teachings of Shah, it would have been obvious to arrive at a method of treating malaria by administering the above resulting compound, because there would be a reasonable expectation that such a compound would be effective in treating a malarial infection.
Claim 6 recites a pharmaceutical composition comprising the following molecular structure:
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As iterated the rejection of claim 2, Shah obviates a compound of the recited structure. Shah also teaches the administration of their compounds in a saline composition. Accordingly, a composition comprising such a compound would also be obvious for the same reasons.
Claim 8 further limits the composition of claim 6 wherein the composition comprises a compound of the following structure:
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As indicated in the rejection of claim 2, the teachings of Shah obviate at least the following compound:
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The compound of the instant claim appears to be a fluorinated version of the previously indicated obvious compound. While Shah does not explicitly teach the individual compound of the instant claim, a person of ordinary skill in the art would reasonably expect that such a fluorinated compound would still be effective in treating a malarial infection, as fluorination is a common technique in the art of drug discovery. A person of ordinary skill in the art would reasonably expect that a compound such as the one recited in the instant claim would have bioisosteric activity, and therefore similar effects to the base compound.
Claim 11 further limits the composition of claim 6 wherein the composition comprises a compound of the following structure:
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As iterated in the rejection of claim 2, the teachings of Shah obviate such a compound, as the building block moieties are provided in compounds 7, 8, and 17 of Shah.
Claim 12 further limits the composition of claim 6 wherein the composition comprises a compound of the following structure:
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As indicated in the rejection of claim 2, the teachings of Shah obviate at least the following compound:
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The compound of the instant claim appears to be a fluorinated version of the previously indicated obvious compound. While Shah does not explicitly teach the individual compound of the instant claim, a person of ordinary skill in the art would reasonably expect that such a fluorinated compound would still be effective in treating a malarial infection, as fluorination is a common technique in the art of drug discovery. A person of ordinary skill in the art would reasonably expect that a compound such as the one recited in the instant claim would have bioisosteric activity, and therefore similar effects to the base compound.
Claim 15 further limits the composition of claim 6 wherein the composition comprises a compound of the following structure:
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As indicated in the rejection of claim 2, the teachings of Shah obviate at least the following compound:
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The compound of the instant claim appears to be a fluorinated version of the previously indicated obvious compound. While Shah does not explicitly teach the individual compound of the instant claim, a person of ordinary skill in the art would reasonably expect that such a fluorinated compound would still be effective in treating a malarial infection, as methylation is a common technique in the art of drug discovery. A person of ordinary skill in the art would reasonably expect that a compound differing by only a single methyl group would have bioisosteric activity, and therefore similar effects to the base compound.
Claim 16 further limits the composition of claim 6 wherein the composition comprises a compound of the following structure:
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As indicated in the rejection of claim 2, the teachings of Shah obviate at least the following compound:
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The compound of the instant claim appears to be a fluorinated version of the previously indicated obvious compound. While Shah does not explicitly teach the individual compound of the instant claim, a person of ordinary skill in the art would reasonably expect that such a fluorinated compound would still be effective in treating a malarial infection, as chlorination is a common technique in the art of drug discovery. A person of ordinary skill in the art would reasonably expect that a compound such as the one recited in the instant claim would have bioisosteric activity, and therefore similar effects to the base compound.
Claim 17 further limits the composition of claim 6 wherein the composition comprises a compound of the following structure:
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The compound of the instant claim appears to be a fluorinated version of the previously indicated obvious compound. While Shah does not explicitly teach the individual compound of the instant claim, a person of ordinary skill in the art would reasonably expect that such a fluorinated compound would still be effective in treating a malarial infection, as chlorination and fluorination are common techniques in the art of drug discovery. A person of ordinary skill in the art would reasonably expect that a compound such as the one recited in the instant claim would have bioisosteric activity, and therefore similar effects to the base compound.
Allowable Subject Matter
The prior art does not appear to teach or suggest the individual compounds of claims 4-5, and 7, 9-10, and 14, or compositions thereof. The closest prior art to the individual compounds of the aforementioned claims is Shah (previously referenced). While the aforementioned claims may be indicated as containing allowable subject matter, the claims are not in condition for allowance due to being dependent on previously rejected claims, and are accordingly objected to (see claim objections).
Shah teaches artemisinin derivatives as compounds having antimalarial activity. Of particular relevance to the compounds of the instant claims are the following compounds 17 and 18 (Fig. 1, page 5327):
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With regards to the compounds of claims 4-5, 7, and 10, the above compounds differ in the moiety attached to the right-most carbonyl group:
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Shah does not appear to make any suggestions of moiety replacements which would anticipate or obviate the compounds of claims 4-5, 7, and 10.
Claims 9 and 14 recite the following compounds:
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The above compounds differ from Shah in that Shah does not teach or suggest the di-amino carbonyl moiety of claim 9 or the sulfoxide moiety of claim 14.
Conclusion
Claims 1-17 are rejected.
Claims 3-5, and 7, 9-10, and 14 are objected to
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “The purpose of the present investigation was to characterize the partitioning of artemisinin and its derivatives into both non-parasitized as well as Plasmodium falciparum parasitized red blood cells (RBCs). Artemisinin and selected derivatives at concentrations of 3.55 lM were incubated in RBCs with a hematocrit of 33% for 2 h at 37 C, extracted from RBCs by solid phase extraction, and analyzed using liquid chromatography–mass spectrometry in positive electro-spray ionization mode with methanol as mobile phase.”
2 “the drug was reconstituted in 10.0 mL of physiological saline. An aliquot (1 mL) of drug solution was further diluted with 3.7 mL of saline in a 25-mL conical flask along with 2.3 mL of non-parasitized or parasitized RBCs. For the blank, 2.3 mL of saline was added in place of non-parasitized or parasitized RBCs. The glassware was treated with 5% (v/v) dimethyldichlorosilane in toluene to minimize the possibility of glass binding prior to use. The final drug concentration was 3.55 lM, with a RBC hematocrit of 33%.”
3 “One of the most promising new classes of antimalarial drugs is the derivatives of artemisinin, a drug that was originally isolated from an ancient Chinese herbal remedy.2 Artemisinin derivatives are the most rapidly acting of all antimalarial drugs, effective by all routes of administration. They already have an established role in the treatment of multidrug-resistant Plasmodium falciparum malaria, and no serious adverse effects have been reported in clinical trials.”
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