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 .
Formal Matters
Claims 1-15 were originally presented on 06/27/2023. The preliminary amendments to the claims, also filed on 06/27/2023, have been received and entered. No claims were cancelled or newly added.
Claims 1-15 are pending and under examination.
Priority
This application is a 371 of PCT/JP2021/048741, filed 12/28/2021, which claims benefit to Japanese Application No. 2020-219397, filed 12/28/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed 06/27/2023 and 08/11/2023 have been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
Non-Patent Literature Reference 7 in the IDS filed 06/27/2023 is lined-through as not considered by the Examiner because it is not in the English language and no translation has been provided.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 4-8 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 4 depends from claim 1 and recites the pharmaceutical composition according to claim 1 “which is used for the treatment of a chronic kidney disease”. Claims 5-8 depend from claim 4 and only further limit the chronic kidney disease recited in claim 4.
The claimed recitation of a “use” of the pharmaceutical composition according to claim 1 is indefinite under 35 U.S.C. 112(b) because it is unclear how the pharmaceutical is intended to be “used”, i.e., what steps are intended to be performed. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction."
Claim Rejections - 35 USC § 112(d)
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.
Claims 4-8 are 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.
Claim 4 depends from claim 1 and recites the pharmaceutical composition according to claim 1 “which is used for the treatment of a chronic kidney disease”. Claims 5-8 depend from claim 4 and only further limit the chronic kidney disease recited in claim 4, not the pharmaceutical composition.
Claims 4-8 fail to place any additional structural limitations on the pharmaceutical composition of claim 1 and therefore fail to further limit claim 1 from which they ultimately depend. Recitation of “which is used for the treatment of a chronic kidney disease” is merely an intended use of the composition and does not place any structural limitations on the pharmaceutical composition according to claim 1.
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 § 101
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.
Claims 4-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a “use” but fail to recite steps and are therefore not a proper process/method under 35 U.S.C. 101. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Here, claim 4 recites the pharmaceutical composition according to claim 1, “which is used for the treatment of a chronic kidney disease”. As such, the claim is neither a proper composition of matter nor a proper process/method and therefore is not directed to at least one of the four categories of patent eligible subject matter.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2011/060945 A2 (Published May 26, 2011) (Cited by Applicant in IDS filed 06/27/2023).
Regarding claims 1-3 and 9-15, WO ‘945 teaches pharmaceutical capsules comprising candesartan cilexetil dispersed in oil containing a minimum of 90% of ethyl esters of polyunsaturated fatty acid (PUFA), with a minimum EPA/DHA content of 85% in a ratio of 1.2:1 (Example 4; Table 2) and pharmaceutical capsules comprising valsartan dispersed in oil containing a minimum of 65% of ethyl esters of PUFA, with a minimum EPA/DHA content of 45% in a ratio of 1.2:1 (Example 5). Regarding claims 4-8, as discussed above claims 4-8 fail to further limit claim 1 from which they depend and are therefore also anticipated by WO ‘945, who teach pharmaceutical compositions comprising a renin-angiotensin-system inhibitor [candesartan cilexetil or valsartan] and at least one type of an omega-3 polyunsaturated fatty acid [EPA and DHA] as recited in claim 1. The intended use of the composition according to claim 1 as recited in claims 4-8 is not afforded patentable weight.
Conclusion
Claims 1-15 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2008/0125490 A1 teaches treatment of cardiovascular disease in patients with chronic kidney disease comprising the administration of omega-3 fatty acids, preferably EPA and DHA (e.g., Lovaza™). The compositions and methods of the invention may further comprise co-administration of one or more additional compounds useful in the treatment of CVD or one or more of hypertension, dyslipidemia, obesity and/or diabetes, including angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and renin inhibitors.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038