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 Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/26/26 has been entered.
Claims 1-15, 17-19, 22-24, 31, 33-34 have been cancelled. Claims 16, 20-21, 25-30, 32 are pending. Claims 16, 20, 25, 32 have been amended. Claims 16, 20-21, 25-30, 32 are examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejection of the last Office Action is maintained for reasons of record and modified below as a result of the new claim amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 set forth in Graham vs John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 16, 20-21, 25-30, 32 are rejected under 35 U.S.C. 103(a) as being obvious over Bugbee et al. (“Telmisartan Treatment of Refractory Proteinuria in a Dog,” J. Vet. Intern. Med. 2014, 28, 18*71-1874, of record) in view of Caro-Vadillo et al. (“Effect of a combination of telmisartan and amlodipine in hypertensive dogs,” Vet. Rec. Case Rep. 2018, 6, 2, e000471, of record) and EP 1 908 469 (of record).
The instant claims are directed to a method for the treatment of elevated urinary protein-to-creatinine ratio (UPC) levels in a dog by administering telmisartan.
Bugbee et al. teach a 6-year-old female dog with a history of refractory proteinuria, also known as protein losing nephropathy (PLN), having elevated UPC levels and systemic hypertension (page 1871, left column, first two sentences). Telmisartan was prescribed at a dosage of 0.43 mg/kg once daily for 7 days and then increased to 0.43 mg/kg twice daily (0.86 mg/kg total daily), in combination with benazepril (page 1871, right column, last two sentences). The dose of telmisartan was increased to 0.79 mg/kg in the morning and 0.38 mg/kg in the evening (1.17 mg/kg total daily). Finally, the dose of telmisartan was reduced to 0.9 mg/kg once daily (page 1872, left column, second full paragraph). UPC reductions of 70% and 95.9% were noted within 2 weeks and 3 months of first administration of telmisartan (page 1872, left column, third full paragraph). Treatment with ACEi decreases proteinuria in naturally occurring models of chronic kidney disease (CKD) in dogs (page 1872, right column, first full paragraph).
However, Bugbee et al. fail to disclose 1.0 mg/kg daily dose of telmisartan for the first period, 1.75 mg/kg daily dose of telmisartan for the second period, and the telmisartan sodium or potassium salt.
Caro-Vadillo et al. teach that the telmisartan is known in veterinary medicine to reduce proteinuria associated with CKD. The standard recommended dose in the management of proteinuria in dogs is 1 mg/kg. It has also been reported to have an effect on blood pressure in dogs at a 1 mg/kg daily dose (page 2, left column, paragraphs 3 and 5).
EP 1 908 469 teaches sartans, for example telmisartan, as a group of angiotensin II receptor antagonists developed for the treatment of hypertension. Telmisartan is further taught to be available in sodium salt form (paragraph 0022-0025).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to have used a 1 mg/kg dose of the sodium salt of telmisartan, as taught by Caro-Vadillo et al. and EP 1 908 469, in the method of treating elevated urinary protein-to-creatinine ratio (UPC) levels in a dog for the first period, followed by at least 1.75 mg/kg in the second period, as taught by Bugbee et al.
A person of ordinary skill in the art would have been motivated to have used a 1 mg/kg dose of the sodium salt of telmisartan because Caro-Vadillo et al. teach that this amount is the standard recommended dose in the management of proteinuria. Further, going from 0.43 mg/kg to 1 mg/kg is within routine experimentation to one of ordinary skill in the art. Furthermore, an increase to 1.75 mg/kg in the second period is also obvious since Bugbee et al. teach increasing the dose 0.74 mg/kg after the first period. Therefore, the skilled artisan would have had a reasonable expectation of success in treating elevated urinary protein-to-creatinine ratio (UPC) levels in a dog by administering a 1 mg/kg dose of the sodium salt of telmisartan in the first period followed by 1.75 mg/kg dose in the second period.
Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382; lt has been held that it is within the skills in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. In re Boesch, 205 USPQ 215 (CCPA 1980) MPEP 2114.04
Response to Arguments
Applicant argues that Bugbee teaches treatment of a dog suffering from refractory proteinuria, which is not the same as CKD or PLN, since proteinuria is not necessarily due to CKD or PLN.
This is not persuasive because one of ordinary skill in the art knows that proteinuria is heavily associated and the major symptom of CKD or PLN, therefore having the same reasonable expectation of success in treating CKD or PLN as with proteinuria. Regardless, the secondary reference, Cado-Vadillo, clearly teaches proteinuria associated with CKD, which meets this limitation.
Applicant argues that Cado-Vadillo relates to the treatment of systemic hypertension in a dog that happens to be suffering from CKD. Therefore, the treatment using the combination of amlodipine with telmisartan is clearly for the purposes of reducing blood pressure and addressing systemic hypertension, not the reduction of UPC in the dog’s urine or treatment of CKD.
This is not persuasive because, while Cado-Vadillo teaches the treatment of hypertension, the reference also clearly teaches that telmisartan is known in veterinary medicine to reduce proteinuria associated with CKD.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that EP 1 908 469 relates to treatment of systemic diseases in cats, not dogs. Therefore, there is no indication that administration of a pharmaceutical drug in a cat would have the same pharmacological effect in a different species, such as a dog or any other mammal.
This is not persuasive because the reference was merely relied on to teach that telmisartan is available in sodium salt form.
Finally, Applicant argues that claim 30 now recites that the dog suffers from proteinuria that is non-refractory to treatment with ACE inhibitors. Bugbee describes treatment of refractory proteinuria in a dog (refractory to ACE inhibitors).
This is not persuasive because while Bugbee teaches the treatment of refractory proteinuria, which is proteinuria that is resistant, stubborn, or fails to respond adequately to standard medical therapies, one of ordinary skill in the art would expect a higher level of success in treating non-refractory proteinuria, since the disease is expected to respond well to standard treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. 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).
/Yong S. Chong/Primary Examiner, Art Unit 1623
Prosecution Insights