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 .
Information Disclosure Statements
The information disclosure statements (IDS) dated November 6, 2025 and November 26, 2025 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: the claims drawn to the elected species remain unallowable. Accordingly, the scope of the search and consideration was not expanded further.
Response to Remarks and Amendments
Applicants’ response and amendments filed November 24, 2025 has been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With regard to the rejection of claims 17-18 under 35 USC 103 (Stark and Brown); the rejection of claims 1-3, 6-15 and 19-22 under 35 USC 103 (Stark, Brown and Arenas-Lopez), and double patenting rejections set forth in the previous action, Applicants traverse the rejections on several grounds, each of which has been considered but was not found to be persuasive. Notably, in view of the amendments to claims 17-18, the claims are now included in the rejection for obviousness in view of Stark, Brown and Arenas-Lopez.
Applicants traverse the rejection with respect to claim 1 noting that no combination of Stark with Brown or Arenas-Lopez fairly teaches or suggests the syringe used for administration, a feature for which Arenas-Lopez was relied upon, which can accurately change a liquid dose in 0.10 mL increments or less. Applicants contend that 1 mL syringes were found inaccurate below volumes of 0.25 mL, where Table 2 of the reference shows that dosage accuracy is unreliable for doses 0.1 mL or less, particularly for syringes less than 1mL volume or greater. Upon further consideration, the examiner agrees that the reference teaches away from a syringe having a volume of 1 mL or greater for dispensing volumes of 0.10 mL or less. Accordingly, any claim requiring this feature is no longer included in the rejection.
Claims 17-19 do not require a syringe with a total volume of 1 mL or greater, and do not preclude the use of a lower volume syringe to dispense the 0.10 mL increments of drug, which would not be expected to have the same accuracy issues.
With respect to claim 17, Applicant separately argues that there is no teaching in Stark that would specifically suggest which criteria to use to vary the administration dosage. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection relies upon the teachings of Brown for its teaching of the criteria for monitoring SBP and lowering the dosage accordingly when SBP drops below 120/80 mmHg.
To this end, Applicants contend that there is no teaching of comparison of the measured SBP to a baseline SBP of 160 or 170 mmHg, followed by lowering the dosage if the SBP is lower than 160 or 170 mmHg. The examiner respectfully disagrees because the claim requires lowering the dosage if the SBP is lower than 160 or 170 mmHg. An SBP reading of 120 mmHg is “below” this threshold and therefore meets the requirements of the claimed threshold. Thus, although the mental comparison step to a value of 160 or 170 mmHg may be different, the steps of the claimed method would be the same when the subject has SBP at 120mmHg or less, since the end result of observing such a value would be decreasing the dosage both in the prior art and in the instant claims. To this end, MPEP 2144 states that "The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem.” It is not necessary that the prior art suggest the decrease in dosage in response to comparison to the same baseline, if the resulting method would ultimately be the same. The only range under which there would be a different between the instant claims and the prior art would be for measured values greater then 120 mmHg but less than 160 or 170 mmHg. However, the claimed scope is not limited in this way such that the claims are still obvious.
Applicant further traverses the ODP rejections of each patent family member of the Stark patent, relying upon the same reasons as argued in the traversal of the 35 USC 103 rejections. For at least the reasons described in the examiner’s response to the traversals above, as well as those set forth in the rejections, the double patenting rejections are maintained herein over claims 17-19.
Status of Claims
Currently, claims 1-3, 6-15 and 17-22 are pending in the instant application and are under consideration in the instant application to the extent that they read on the elected embodiment.
Claim Objections
Claim 25 is objected to for depending on a rejected base claim, but appears allowable if rewritten in independent form.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 9,308,197 (“the ‘197 publication”) and Brown et al. ACVIM Consensus Statement; J. Vet. Intern. Med. 2007; 21:542-558, and further in view of Arenas-Lopez et al. (NPL document cited with PTO-892 dated 6/12/2020 in parent application).
Determining the scope and contents of the prior art
The ‘197 publication teaches pharmaceutical compositions for prophylaxis or treatment of systemic diseases in cats, where the composition comprises administration of a sartan to a cat in need thereof (see Abstract). The dosages are described as being at least 0.75 mg/kg and not greater than 5.0 mg/kg body weight, that the administration is daily over a period of 4 weeks, and further the dosage amount may be varied throughout the treatment period. The oral administration, provided in a single daily dose is taught by the prior art (for example, claims 6-7 of the ‘197 publication), while the plurality of doses is taught for example in claim 9 of the ‘197 publication. The examples provided in the ‘197 publication establish that the method may be conducted on a cat of approximately 1 year in age (See Example 3). The elected species of telmisartan is disclosed throughout the reference, but also specifically administered in the Examples and recited specifically in claim 3 of the ‘197 publication.
Ascertaining the differences between the prior art and the claims at issue
The difference between the instant invention and the prior art is that the prior art does not teach a specific example where the daily dosage of sartan is decreased for a second period of time during the treatment period, nor that said decrease is based on the measured systolic blood pressure of the subject being treated being less than 160 mmHg or 170 mmHg.
Regarding the limitations of claim 19, the combination of the ‘197 publication and Brown et al. do not teach the syringe having volumetric markings at 0.10 mL increments or less.
Resolving the level of ordinary skill in the pertinent art
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Accordingly, it would not have been considered inventive for the skilled artisan to follow the explicit suggestion of the prior art to vary the dosage based on the observed blood pressure of the patient. Doing so would have been obvious because a person of ordinary skill in the art (in this case a veterinary medical professional) would be monitoring the blood pressure of a cat known to have high blood pressure, and modify the dosage as necessary since the ‘197 publication explicitly describes varying dosages. The skilled artisan would have reasonably expected success in doing so since the primary reference teaches success in treating feline hypertension with telmisartan.
In addition to the explicit suggestion in the primary reference, it is noted that Brown et al. details the specifics of management of feline hypertension with a stepwise approach as detailed in Figure 2:
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Notably, the hypertension approach described by Brown et al. includes re-evaluation in 7-10 days and decreasing the dosage if the cat has become hypotensive (described as having a blood pressure less than 120/80 mmHg, which reads on the SBP of less than 160 or 170 mmHg required by the instant claims). In modifying the dosage during the second time period, it would have been customary and obvious for a person of ordinary skill in the art to select from within the preferred range described by the primary reference as the optimal dosage for using a sartan to treat a feline subject.
With respect to the particular dosage range recited in claims 17-18, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”).
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Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0, explaining “[t]hat which infringes if later anticipates if earlier”); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d 329, 332 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. Appx. 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); Gentiluomo v. Brunswick Bowling and Billiards Corp., 36 Fed. Appx. 433 (Fed. Cir. 2002)(non-precedential)(disagreeing with argument that overlapping ranges were required to find a claim prima facie obvious).
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"[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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 Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”).
As such, the optimizations made in the instant claims are obvious in view of the prior art teachings. In the absence of showing unobvious results, it would have been obvious to one of ordinary skill in the art at the time of the invention when faced with the prior art that to conduct the methods of the instant claims with a reasonable expectation of success in doing so.
Pertaining to the limitations of claim 19, regarding the graduated dosage markings on the syringe used to administer the dosage, based on the teachings of the MPEP and KSR above, by employing the rationale in (B), (D), (E) or (G) above, it would have been obvious for one of ordinary skill in the art to use a well-known syringe design for dispensing the oral medication. Arenas-Lopez et al. describe the accurate dosing capability of oral syringes, ranging in size from 1 to 5 mL. In particular, the wide tip 1mL, 2.5mL and 5mL syringes are described as having 0.01mL, 0.1mL and 0.2mL graduations, respectively (p. 5). Given the data on which particular brands and size of oral syringe are the most accurate for measuring and dispensing oral formulations, it would have been obvious for a person of ordinary skill in the art to use one of the prior art syringes having the volumetric graduation marks as claimed, in order to ensure accurate measurement and dosing of the prescription at the dosage deemed suitable by the provider.
Double Patenting
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-6 of U.S. Patent No. 8,772,278;
claims 1-12 of U.S. Patent No. 9,308,197;
claims 1-14 of US Patent No. 9,585,873; and
claims 1-13 of US Patent 10,357,479.all in view of Brown et al. ACVIM Consensus Statement; J. Vet. Intern. Med. 2007; 21:542-558 and further in view of Arenas-Lopez et al. (NPL document cited with PTO-892 dated 6/12/2020 in parent application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The above patents relate to methods of treating systemic disease in cats (‘278), where the disease may be a metabolic disease (‘479), chronic kidney disease (‘873), or hypertension (‘197). Each patent recites administration of an AT-1 receptor antagonist which is defined as being, for example, telmisartan (e.g. claim 6 of ‘278 patent). The dosages are claimed as being 3.0 mg/kg body weight (see ‘278 patent, which anticipates that of the instant claims) and the ‘197 patent discloses that the administration is daily over a period of 4 weeks (claim 10) and the dosage amount may be varied throughout the treatment period (claim 11). Thus, any variation in the particular dosage amount, based on the treatment method conducted by the conflicting claims, would have at the very least been obvious to a person of ordinary skill in the art monitoring the effect of the administration on the subject being treated. The oral administration, provided in a single daily dose is taught by the conflicting claims (for example, claims 6-7 of the ‘197 patent), while the plurality of doses is taught for example in claim 9 of the ‘197 patent. The examples provided in support of each method of the conflicting claims provide that while the claims are generic as to the age of the cat, the method may be conducted on a cat of approximately 1 year in age (See Example 3).
Notably, with respect to the new claims reciting particular interval markings on the syringe for administration, it is noted that this is not interpreted as adding any patentable limitation to the claimed method since the effect of the administration (the treatment of the same disease in the same patient with the same drug) would be the same regardless of the implement used to dose the medication.
With respect to the instantly claimed method, the patented claims do not explicitly recite the daily dosage of sartan is decreased for a second period of time during the treatment period, nor that said decrease is based on the measured systolic blood pressure of the subject being treated being less than 120mmHg.
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Accordingly, it would not have been considered inventive for the skilled artisan to follow the explicit suggestion of the reference patent claims to vary the dosage based on the observed blood pressure of the patient. Doing so would have been obvious because a person of ordinary skill in the art (in this case a veterinary medical professional) would be monitoring the blood pressure of a cat known to have high blood pressure, and modify the dosage as necessary since the ‘197 publication explicitly describes varying dosages. The skilled artisan would have reasonably expected success in doing so since the primary reference teaches success in treating feline hypertension with telmisartan.
In addition to the suggestion in the reference patent claims, it is noted that Brown et al. details the specifics of management of feline hypertension with a stepwise approach as detailed in Figure 2:
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Notably, the hypertension approach described by Brown et al. includes re-evaluation in 7-10 days and decreasing the dosage if the cat has become hypotensive (described as having a blood pressure less than 120/80 mmHg, which reads on the precise SBP of less than 120 mmHg required by the instant claims). In modifying the dosage during the second time period, it would have been customary and obvious for a person of ordinary skill in the art to select from within the preferred range described by the primary reference as the optimal dosage for using a sartan to treat a feline subject. Notably, the process shown in Brown et al. above includes a feedback loop which would include a second re-evaluation and further decrease in dosage for a third period of time if BP had reached less than 120/80mmHg as required by the limitations of new claim 22. Further, with respect to claim 17, 120/80mmHg is considered to read on “at or below” a threshold value of 160 or 170mmHg since 120 is less than each of the claimed threshold values.
With respect to the decrease in dosage by an amount ranging from 0.1 to 0.5 mg/kg body weight, it is noted that the decrease in dosage suggested by Brown would still be optimized within the range indicated as being most preferable for treating hypertension in cats with a sartan. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”).
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Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0, explaining “[t]hat which infringes if later anticipates if earlier”); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d 329, 332 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. Appx. 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); Gentiluomo v. Brunswick Bowling and Billiards Corp., 36 Fed. Appx. 433 (Fed. Cir. 2002)(non-precedential)(disagreeing with argument that overlapping ranges were required to find a claim prima facie obvious).
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"[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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 Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”).
As such, the optimizations made in the instant claims are obvious in view of the conflicting claims in view of the prior art. In the absence of showing unobvious results, it would have been obvious to one of ordinary skill in the art at the time of the invention when faced with the prior art that to conduct the methods of the instant claims with a reasonable expectation of success in doing so.
With respect to the limitations pertaining to the syringe and dosage markings imported into amended claim 1, based on the teachings of the MPEP and KSR above, by employing the rationale in (B), (D), (E) or (G) above, it would have been obvious for one of ordinary skill in the art to use a well-known syringe design for dispensing the oral medication. Arenas-Lopez et al. describe the accurate dosing capability of oral syringes, ranging in size from 1 to 5 mL. In particular, the wide tip 1mL, 2.5mL and 5mL syringes are described as having 0.01mL, 0.1mL and 0.2mL graduations, respectively (p. 5). Given the data on which particular brands and size of oral syringe are the most accurate for measuring and dispensing oral formulations, it would have been obvious for a person of ordinary skill in the art to use one of the prior art syringes having the volumetric graduation marks as claimed, in order to ensure accurate measurement and dosing of the prescription at the dosage deemed suitable by the provider.
Conclusion
Claims 1-3, 6-15 and 20-24 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699