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 .
Status of the Claims
Claims 1, 4-5, 7-15, 17 and 19-26 are pending.
Election of Invention
Applicants’ election without traverse (see page 7 of Remarks filed on 05/27/2026), of the invention of Group I, claims 1, 4-5, 7-15, 17, 9-22 and 24-26, is acknowledged and entered.
Applicants’ election without traverse (see page 8 of Remarks filed on 05/27/2026), of the following species is acknowledged and entered:
A method for treating impaired mevalonic acid production, as the elected method.
Claim 23 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention. Therefore, claims 1, 4-5, 7-15, 17, 9-22 and 24-26 are subject of the Office action below.
Priority
This application filed on 02/08/2024, is a 371 of PCT/IB2022/057432, filed on 08/09/2022, which claims priority to U.S. provisional application No. 63/231,050, filed on 08/09/2021.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see e.g., pages 23, 26 and 33 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. Please see MPEP § 608.01.
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 1, 4-5, 7-15, 17, 9-22 and 24-26 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. Claims 4, 7, 10-15, 17 and 21-22 depend from claim 1 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reasons set forth below. Claims 19, 24 and 26 depend from claim 5 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reasons set forth below. Claims 9 and 25 depend from claim 8 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Each of claims 1, 5 and 8, recites the limitation of “a therapeutically effective amount”, however, a person of the ordinary skill in the art cannot reasonably determine the meets and bounds of the recited limitation in the claims. The specification (see, e.g., page 18, lines 21-27), states:
“The term "therapeutically effective amount" as used herein, means the amount or dose of a compound, e.g., mevalolactone, that, when administered to a subject for treating a disease, disorder or condition, as defined herein, is sufficient to effect such treatment for the disease, disorder or condition. The therapeutically effective amount may sometimes be the lowest dose
level that yields a therapeutic benefit to patients, on average, or to a given percentage of patients. The 'therapeutically effective amount' can vary depending on the compound, the disease and its severity, and the age, weight, etc., of the subject to be treated.” Emphasis added.
The term “a therapeutically effective amount” is a relative set of measure in that it is not defined by the claim or the specification to any specific dosage or dosage range, for mevalonolactone. The specification does not provide a standard for ascertaining the requisite degree. Thus, a person skilled in the art would not be able to draw a clear boundary between what is and is not covered by the claim.
The phrase “an effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. Please see MPEP § 2173.05(c)(III).
In the instant case, the more than one effect that can implied from the specification are treating, preventing, alleviating or ameliorating: i) impaired mevalonic acid production; ii) cell and/or tissue damage; iii) impaired mevalonate pathway; and iv) a disease or condition associated with impaired HMGCR function. The specification does not appear to provide guidelines that are elaborate enough for determining “a therapeutically effective amount” for the mevalonolactone, recited in claims 1, 5 and 8, which would treat, prevent, alleviate or ameliorate: i) impaired mevalonic acid production; ii) cell and/or tissue damage; iii) impaired mevalonate pathway; and iv) a disease or condition associated with impaired HMGCR function. A person skilled in the art cannot tell from the specification, what is “a therapeutically effective amount” for the mevalonolactone, recited in claims 1, 5 and 8.
A patent must be precise enough to afford clear notice of what is claimed, thereby "'appris[ing] the public of what is still open to them.'" Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (quoting McClain v. Ortmayer, 141 U.S. 419, 424 (1891)). Otherwise, there would be "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims." United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942). A claim fails to satisfy this statutory requirement and is thus invalid for indefiniteness if its language, when read in light of the specification and the prosecution history, "fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014).
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
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.
Claims 1, 4-5, 7-15, 17, 9-20, 22 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishimoto et al (hereinafter “Nishimoto”, Toxicology & Applied Pharmacology, 2007, 223, 39-45).
By way of a background, Applicants’ invention (see, e.g., pages 1-3 of the specification), is drawn to a method for treating, preventing or alleviating, for example, impaired mevalonic acid production or a disease associated with impaired mevalonic acid production in a subject in need thereof, with mevalonolactone. Applicants (see page 5, lines 7-12 and pages 32-33 of the specification), provides a working example of administering cerivastatin alone or cerivastatin in combination with mevalonolactone, to mice (subjects in need thereof), and evaluate the effect of mevalonolactone on statin-induced cytotoxicity. Based on the treating mice with cerivastatin alone or cerivastatin in combination with mevalonolactone (see discussions above), Applicants are claiming to have invented a method for treating, preventing or alleviating, for example, impaired mevalonic acid production or a disease associated with: i) impaired mevalonic acid production; or ii) impaired function of HMGCR, in a subject in need thereof, with a therapeutically effective amount of mevalonolactone.
The term “a therapeutically effective amount” is a relative set of measure in that it is not defined by the claim or the specification to any specific dosage or dosage range, for the mevalonolactone. Accordingly, for the purpose of examination, any amount of mevalonolactone that is employed in order to generate the desired therapeutic outcome, is included in the interpretation of “a therapeutically effective amount”.
Similar to the Applicants’ invention (see discussions above), Nishimoto (see “Materials and Methods” section on page 40), teaches a method comprising orally administering cerivastatin alone or cerivastatin in combination with DL-mevalonolactone, to guinea pigs (subjects in need thereof), and evaluate the effect of mevalonolactone on cerivastatin-induced cytotoxicity (see, e.g., abstract, “Results” section on pages 41-44 and Figures 1-6). Cerivastatin-induced cytotoxicity is caused by the inhibition of HMGCR (see page 42, right column ¶s). The above disclosure of administering cerivastatin alone or cerivastatin in combination with mevalonolactone, to guinea pigs (subjects in need thereof), is interpreted as a method for treating, preventing or alleviating, for example, impaired mevalonic acid production or a disease associated with: i) impaired mevalonic acid production; or ii) impaired function of HMGCR, in a subject in need thereof.
Therefore, claims 1, 4-5, 7-15, 17, 9-20, 22 and 26 are anticipated by Nishimoto.
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.
Claims 1, 4-5, 7-15, 17, 9-22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimoto (Toxicology & Applied Pharmacology, 2007), as applied to claims 1, 4-5, 7-15, 17, 9-20, 22 and 26 above and in view of Orru et al (hereinafter “Orru”, Synthesis, 1998, 9, 1259-1263).
The limitations of claims 1, 4-5, 7-15, 17, 9-20, 22 and 26 and the corresponding teachings of Nishimoto, are described above and hereby incorporated into the instant rejection.
The invention of claims 21 and 24-25 are similar to claims 1, 5 and 8, however, claims 21 and 24-25 differ slightly from claims 1, 5 and 8 in that claims 21 and 24-25 require that the mevalonolactone is D- mevalonolactone (i.e., R-(-)- mevalonolactone).
Although Nishimoto teaches DL-mevalonolactone (see discussions above), Nishimoto differs from claims 21 and 24-25 only insofar as Nishimoto is not explicit in teaching D- mevalonolactone (i.e., R-(-)-mevalonolactone), which is the naturally occurring mevalonolactone stereo isomer (see page 2 of the specification).
However, the claimed invention would have been obvious over Nishimoto, because at the time of the instant invention, D- mevalonolactone (i.e., R-(-)- mevalonolactone), was known in the art. For example, Orru (see, e.g., abstract) discloses R-(-)-mevalonolactone as the naturally occurring stereo isomer of mevalonolactone.
Accordingly, at the time of the instant invention, a person skilled in the would have envisaged a method for treating, preventing or alleviating, for example, impaired mevalonic acid production or a disease associated with: i) impaired mevalonic acid production; or ii) impaired function of HMGCR, in a subject in need thereof, with R-(-)-mevalonolactone, from the disclosures of Nishimoto and Orru. A person skilled in the art would have considered administering the naturally occurring R-(-)-mevalonolactone of Orru over the racemic DL- mevalonolactone of Nishimoto, with a reasonable expectation that the naturally occurring R-(-)-mevalonolactone would be more biocompatible.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference. Therefore, the invention as a whole was prima facie obvious at the time it was made.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights