DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1-10 are pending
Priority
This application filed on 07/16/2024, is a CON of U.S. application No. 17/662,866, filed on 05/11/2022 (U.S. patent No. 12,083,102), which is a CON of U.S. application No. 16/654,912, filed on 10/16/2019 (U.S. patent No. 11,382,896), which is a CON of U.S. application No. 15/704,713, filed on 09/14/2017 (U.S. patent No.10,525,038), which is a CON of U.S. application No. 15/086,823, filed on 03/31/2016 (U.S. patent No.10,058,555), which is a DIV of U.S. application No. 13/979,127, filed on 07/10/2013 (U.S. patent No. 9,314,450), which is a 371 of PCT/AU2012/000014, filed on 01/11/2012, which claims benefit of:
i) Australian Patent Application Nos: a) 2011900060, filed on 01/11/2011; and b) 2011904279, filed on 10/17/2011; and
ii) U.S. provisional application Nos: a) 61/432,896, filed on 01/14/2011; and b) 61/547,951, filed on 10/17/2011.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/16/2024, were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 1-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ziai et al (hereinafter, “Ziai”, Kidney Int.., 1996, 57, S132-6, Abstract used for the rejection), in view of Kanamori (Biochemical and Biophysical Research Comm., 2007, 360, 772-777).
Independent claim 1 is directed to a method for treating or ameliorating an MCP-1 mediated or CCR2 mediated condition or disease in a subject comprising administering to the subject, an effecting amount of a composition comprising:
a) at least one CCR2 inhibitor1; and
b) at least one AT1R blocker.
Claim 1 does not specify: i) a particular subject; or ii) a particular CCR2 inhibitor; or iii) a particular AT1R blocker. Accordingly, for the purpose of examination:
i) any human or animal having an MCP-1 mediated or CCR2 mediated condition or disease, is included in the interpretation of “a subject”.
ii) any AT1R blocker that is employed in the treatment an MCP-1 mediated or CCR2 mediated condition or disease, is included in the interpretation of “at least one AT1R blocker”.
iii) CCR2 inhibitor that is employed in the treatment an MCP-1 mediated or CCR2 mediated condition or disease, is included in the interpretation of “CCR2 inhibitor”.
Similar to claim 1, Ziai teaches a method of treating glomerulosclerosis (an MCP-1 mediated or CCR2 mediated condition or disease, see instant claim 7) in rats comprising administering irbesartan to the rats. Treatment with irbesartan was found to result in a marked reduction in glomerulosclerosis. Ziai discloses irbesartan as an AT1R blocker. Please see abstract.
Although Ziai is not explicit in teaching use of irbesartan in combination with a CCR2 inhibitor the claimed invention would have been obvious over Ziai.
This is because at the time of the instant invention, treatment of glomerulosclerosis with a CCR2 inhibitor was known in the art. For example, similar to Ziai (see discussions above), Kanamori teaches a method for ameliorating glomerulosclerosis with propagermanium (a CCR2 inhibitor, see, e.g., page 18 of the specification). Kanamori teaches propagermanium as a CCR2 inhibitor. Please see abstract and discussions therein.
Therefore, at the time the instant invention was made, a person skilled in the art would have found it obvious to modify Ziai with Kanamori in order to arrive at a method of using a composition comprising: a) at least one AT1R blocker (e.g., irbesartan, see discussions above); and b) propagermanium (a CCR2 inhibitor, see discussions above), with a reasonable expectation of treating or ameliorating glomerulosclerosis. This is because:
1) Ziai teaches a method for ameliorating glomerulosclerosis with irbesartan (an AT1R blocker). Please see discussions above.
2) Kanamori teaches a method for ameliorating glomerulosclerosis with propagermanium (a CCR2 inhibitor). Please see discussions above.
One skilled in the art would have considered employing an AT1R blocker (e.g., irbesartan) in combination with a CCR2 inhibitor (e.g., propagermanium), in order to broaden the spectrum of activity. The skilled artisan would have had a reasonable expectation that a combination therapy of irbesartan and propagermanium would exhibit greater therapeutic efficacy, when compared to the therapeutic efficacy of individual components alone.
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).
The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Therefore, claim 1 is obvious over Ziai and Kanamori.
Regarding claims 2 and 10, the recitation of the intended outcome of the execution of the method steps of claim 1, resulting in for example, the CCR2 inhibitor inhibiting MCP-1 (claim 2), is not given any patentable weight because the recited clause is simply expressing the intended result of a process positively recited (see Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Please see claim interpretation in the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, discussed above.
Since Ziai and Kanamori combined to teach a method of claim 1 (see discussions above), the method of Ziai and Kanamori must necessarily produce the same outcome recited in claims 2 and 10. This is because each of the recited outcome is a natural process that flows from the subject and the administered CCR2 inhibitor and AT1R blocker. Therefore, claims 2 and 10 are obvious over Ziai and Kanamori.
Regarding claim 3, Ziai teaches irbesartan (see discussions above).
Regarding claim 4:
a) Ziai teaches irbesartan at 240 mg/L (see abstract); and
b) Kanamori teaches 0.005 wt% of propagermanium (see page 773, under the title “Methods”), and 0.005 wt% = 50 mg/kg.
Regarding claims 5-6, each of the recited dosing schedule is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Regarding claims 7-9, Ziai and Kanamori combine to teach glomerulosclerosis (see discussions above).
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
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 reference, 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 references.
Therefore, the invention as a whole was prima facie obvious at the time it was made.
Non-Statutory Double Patenting Rejection
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the following U. S. Patent Nos:
9,314,450 (claims 1-20);
12,083,102 (claims 1-8);
10,058,555 (claims 1-12);
10,525,038 (claims 1-22);
10,758,540 (claims 1-26); and
11,382,896 (claims 1-7).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the cited patents and the instant application are similarly drawn to a composition comprising: a) at least one AT1R blocker; and b) at least one CCR2 inhibitor; and c) a method of using the composition.
Since the cited patents clearly provides for a method of using the same inventive composition, the selection of a method of using the same a composition comprising: a) at least one AT1R blocker or a pharmaceutically acceptable salt thereof; and b) at least one CCR2 inhibitor or a pharmaceutically acceptable salt thereof, in order to treat or ameliorate a kidney disease from the cited patents embodiment would have been obvious.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference patent subject matter.
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.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Selected from a direct CCR2 antagonist, an inverse CCR2 agonist or a negative allosteric CCR2 modulator.
Prosecution Insights