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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 June 2025 has been entered.
Priority
The application was filed 10 March 2021 and is the national stage entry of PCT/NZ2019/050120 filed 10 September 2019. The Applicant claims priority to foreign application NZ746215 filed 10 September 2018. A translated copy of the foreign document has been provided. Therefore, the effective filing date of the application is 10 September 2018.
Examiner’s Note
The Applicant's amendments and arguments filed 20 November 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 20 November 2025, it is noted that claim 1 has been amended and no new claims have been added. Support for the amendment may be found in para. 57 of the instant specification. No new matter has been added.
Declaration
The declaration under 37 CFR 1.132 filed 20 November 2025 is insufficient to overcome the rejection of claims 1, 6, 7, 9-11, 15-17, 26, 27 based upon the teachings of Green, Eckenhoff, Lubrizol 2005, Merck, and Dixon as set forth in the last Office action because: the Applicant argues unexpected results regarding a certain set of polymers. For example, the Applicant has tested Poloxamer 407, Carbomer 971, Polyox 1105, Polyox 301, Polyox 303, HPMC, Carbomer 980, and Carbomer Ultrez 10 (Declaration pg. 6). The Applicant explains that Carbomer 980, Carbomer Ultrez 10, Polyox 301, and Polyox 303 are able to resist the changes in ion concentrations. However, Poloxamer, HPMC, Carbomer 971P, and Carbomer 934 were not able to resist changes in ion concentrations (Declaration, pg. 4). The Applicant speculates that these polymers are better able to resist these changes due to higher viscosity and/or more crosslinking (Declaration, pg. 6). The Applicant argues that the limitations in claim 1 exclude certain polymers based on the molecular weight and viscosity (Declaration, pg. 7) and that other anionic poly(acrylic acid) interpolymers would also be able to resist the effects of changing cation concentrations (Declaration, pg. 6).
Applicant’s argument is not found persuasive. Higher molecular weight and viscosity polyox is known in the art to have better swelling and gelling abilities, acting as a barrier in drug release studies (Shojaee, abs, pg. 1281). Therefore, it is unsurprising that a drug device in similar conditions, such as an aqueous system or passing through the gastrointestinal tract, would experience a similar effect related to the superior properties of a higher molecular weight or more viscous polymer.
Furthermore, the Applicant points to Figures 1 and 2 (Declaration, pg. 5), which shows comparative payout rates between Carbomer 971 (Figure 1) and Polyox 301 (Figure 2). The instant specification does not seem to demonstrate any further comparative data between the other polymers that the Applicant claims are capable of resisting ion concentration changes (Carbomer 980, Carbomer Ultrez 10, and Polyox 303). The range claimed for the molecular weight and viscosity is also too large for the Applicant to claim and assume that all of these non-ionic polyethylene oxide homopolymers with these broad molecular weights and viscosities would exhibit these same exact properties. Therefore, the data are not commensurate in scope with the claims. “For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
The Applicant argues that Green does not teach a combination of a sucrose fatty acid ester and a polymer and that Green does not specifically point to a sucrose fatty acid ester (Declaration, pg. 8).
Applicant’s argument is not found persuasive. The use of sucrose esters as an acceptable carrier in Green’s teaching is interpreted the same as a sucrose fatty acid ester (sisterna.com, pg. 1).
The Applicant argues that Green does not specifically describe an acrylic acid interpolymer with any of the features as currently claimed or a type C carbomer homopolymer (Declaration, pg. 9).
Applicant’s argument is not found persuasive. Acceptable carriers in Green’s composition include sucrose esters (pg. 23) and hydroxymethyl cellulose (pg. 23), which is a gel former, as evidenced by the specification (para. 193), diluents include polyethylene glycol (other name: polyethylene oxide) (pg. 25) and wetting agents include acrylic acid or methacrylic acid polymers or copolymers (pg. 23). Polyethylene glycol or polyethylene oxide may have a molecular weight of over 20,000 g/mol or under 20,000 g/mol, respective (evidenced by sigmaaldrich.com, pg. 1), which is interpreted as addressing the molecular weight limitation of claim 1.
The Applicant argues that Eckenhoff teaches a permeable wall (Declaration, pgs. 10-11).
Applicant’s argument is not found persuasive. Eckenhoff teaches a wall that is at least a part permeable to the passage of fluid (claim 1), whereas the instant claim recites a body that is “substantially impervious,” which is interpreted that some fluid is capable of passing through.
The Applicant argues that the polymer used with the beneficial agent would not mix with the polymer used in the expandable member (Declaration, pgs. 12-13).
Applicant’s argument is not found persuasive. Instant claim 1 recites “at least one matrix in the barrel.” Therefore, it is interpreted that the barrel may comprise multiple matrices and compartments.
The Applicant argues that Lubrizol does not teach that these polymers are suitable for veterinary applications (Declaration, pg. 13).
Applicant’s argument is not found persuasive. Lubrizol is used as evidentiary evidence to teach that Carbopol 934P used in Eckenhoff’s teaching is an acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol. Lurizol’s teaching for oral administration is interpreted as addressing rumen administration. Additionally, Lubrizol 2005 teaches that Carbopol interpolymers (carbomer homopolymers or copolymers containing a block copolymer of polyethylene glycol and a long chain alkyl acid ester, pg. 3) provide benefits and advantages such as thickening efficiency, suspending capability, long viscous flow (pg. 8), and good controlled release properties (pg. 1).
The Applicant argues that Lubrizol does not provide any guidance to select the polymers to resist changes in cation concentrations (Declaration, pg. 14).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant argues against the combination of references (Declaration, pgs. 15-16).
Applicant’s argument is not found persuasive. Since Eckenhoff does not explicitly teach a cross-linked anionic polymer comprising a block copolymer of polyethylene glycol and a long chain alkyl acid ester in claim 11 or a sucrose ester in claim 1, one of ordinary skill in the art would have been motivated to use a Carbopol interpolymer from Lubrizol’s teaching to address the deficiency in Eckenhoff, as Eckenhoff teaches various Carbopol components (Example 1, pg. 5, ln. 117). Additionally, Eckenhoff and Green teach intraruminal devices that are somewhat impermeable to fluids and can releast at least two active agents. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Claim Objections
Claim 1 is objected to because of the following informalities: there is a period in the middle of the claim after “7 million.” Appropriate correction is required.
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.
Claim 1 is 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 1 recites “a molecular weight of about 0.9 to about 7 million” without any units. The claim is indefinite without the units because the metes and bounds of the limitation cannot be determined.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1, 15-17, 27, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (NZ 554633 A), evidenced by sigmaaldrich.com.
Green et al. teach an intraruminal device capable of releasing at least two active ingredients (entire teaching, abs). The device may comprise an elongated body impervious to rumen fluids, a body defining a barrel having an end outlet, a column of matrices in the barrel, a compression arrangement within the body adapted to bias the column in the barrel to deliver the matrix to the outlet, and a variable geometry device to aid in rumen retention (claim 1). Acceptable carriers include sucrose esters (pg. 23) and hydroxymethyl cellulose (pg. 23), which is a gel former, as evidenced by the specification (para. 193), diluents include polyethylene glycol (other name: polyethylene oxide) (pg. 25) and wetting agents include acrylic acid or methacrylic acid polymers or copolymers (pg. 23), all addressing claim 1. Polyethylene glycol or polyethylene oxide may have a molecular weight of over 20,000 g/mol or under 20,000 g/mol, respective (evidenced by sigmaaldrich.com, pg. 1), which is interpreted as addressing the molecular weight limitation of claim 1. Applicant’s elections of polyethylene oxide and polyacrylic acid are interpreted as also addressing the limitations in claim 1. Active agents include ectoparasiticides (pg. 21), as well as anthelmintics, such as benzimidazoles (pg. 21), which addresses claims 15-17, 27, and 28.
Green et al. do not teach an exact combination of an intraruminal device with a gel former, cross-linked anionic polymer, and non-ionic polymer in claim 1.
In regards to selecting the combination of an intraruminal device, active ingredient, gel former, cross-linked anionic polymer, and a non-ionic polymer, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Green teaches an intraruminal device capable of releasing at least two active ingredients, whereas the claimed invention is directed towards an intraruminal device comprising an active ingredient, a gel former, at least one polymer. Since Green teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 1, 6, 7, 9-11, 15-17, 27, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckenhoff (GB 2179252 A), Green et al. (NZ 554633 A), and Lubrizol 2005, as evidenced by Lubrizol 2020, Merck, and Dixon et al. (Veterinary drug residues).
Eckenhoff teaches an intraruminal dispenser composition (entire teaching; pg. 1, lns. 91-96) comprising a beneficial agent, partially impermeable wall, a hydrogel that expands to displace the formulation (pg. 2, lns. 1-5), an exit (abs), a density element that geometrically conforms to the shape of the dispenser (pg. 3, lns. 78-82), and an internal compartment that holds the contents (pg. 1, lns. 1-18). The internal components may include gel polymers or methyl cellulose derivatives (pg. 5, lns. 83-85, 104-105), which is interpreted as a gel former, polyethylene oxide polymers (interpreted as a homopolymer) with a molecular weight of 10,000-5,000,000 (pg. 5, lns. 121-122), and polyacrylic acid with a molecular weight of 80,000-200,000 (pg. 5, lns. 119-121), and a parasiticide or anthelminthic such as ivermectin or avermectin (pg. 6, ln. 123; pg. 7, lns. 14-15), all addressing claim 1, as well as claims 15, 16, and 28. The polymers used in the composition have a viscosity of 5,000-10,000,000 cP (pg. 5, lns. 92-94), addressing claims 6 and 10. Eckenhoff provides an example using Carbopol 934P, which is an example of a carbomer homopolymer (acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol), as evidenced by Lubrizol (pg. 1), addressing claim 9. Ivermectin and avermectin are examples of a macrocyclic lactone and endo/ectoparasiticidal agent, as evidenced by Merck (pg. 1) and Dixon (pg. 1), addressing claims 17 and 27. The composition comprising polyacrylic acid, as opposed to an acrylate group, is interpreted as having no free anionic groups, addressing claim 7.
Eckenhoff does not explicitly teach a sucrose ester or an exact combination of an intraruminal device comprising an active ingredient, sucrose ester gel former, a non-ionic polymer and/or cross-linked anionic polymer in claim 1. Eckenhoff also does not explicitly teach a cross-linked anionic polymer comprising a block copolymer of polyethylene glycol and a long chain alkyl acid ester in claim 11.
Green et al. teach an intraruminal device capable of releasing at least two active ingredients (entire teaching, abs). The device may comprise an elongated body impervious to rumen fluids, a body defining a barrel having an end outlet, a column of matrices in the barrel, a compression arrangement within the body adapted to bias the column in the barrel to deliver the matrix to the outlet, and a variable geometry device to aid in rumen retention (claim 1). Acceptable carriers include sucrose esters (pg. 23) and hydroxymethyl cellulose (pg. 23), which is a gel former, as evidenced by the specification (para. 193), diluents include polyethylene glycol (other name: polyethylene oxide) (pg. 25) and wetting agents include acrylic acid or methacrylic acid polymers or copolymers (pg. 23).
Lubrizol 2005 teaches that Carbopol interpolymers (carbomer homopolymers or copolymers containing a block copolymer of polyethylene glycol and a long chain alkyl acid ester, pg. 3) provide benefits and advantages such as thickening efficiency, suspending capability, long viscous flow (pg. 8), and good controlled release properties (pg. 1).
In regards to selecting a combination of an antiparasitic agent, gel former, polyacrylic acid, and polyethylene oxide, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Eckenhoff teaches an intraruminal device capable of releasing an active ingredient and further comprising polyethylene oxide and polyacrylic acid, whereas the claimed invention is directed towards an intraruminal device comprising an active ingredient, a gel former, at least one polymer. Since Eckenhoff teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Eckenhoff does not explicitly teach a cross-linked anionic polymer comprising a block copolymer of polyethylene glycol and a long chain alkyl acid ester in claim 11 or a sucrose ester in claim 1, one of ordinary skill in the art would have been motivated to use a Carbopol interpolymer from Lubrizol’s teaching to address the deficiency in Eckenhoff, as Eckenhoff teaches various Carbopol components (Example 1, pg. 5, ln. 117). Additionally, Eckenhoff and Green teach intraruminal devices that are somewhat impermeable to fluids and can release at least two active agents. Generally, it is prima facie obvious to substitute or combine one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Response to Arguments
Applicant's arguments filed 20 November 2025 have been fully considered but they are not persuasive.
The Applicant argues that the inventors identified a previously unknown problem (Remarks, pgs. 5-8).
The arguments of counsel cannot take the place of evidence in the record (see MPEP 2145(I)). The Applicant argues that the claimed invention solves long-felt but needs in the industry. In order to satisfy a long-felt need in the industry, there must be objective evidence that a problem existed in the art for a long period of time without solution, and the need must have been persistent. The long-felt need must not have been satisfied by another before the claimed invention, and the invention itself must satisfy the long-felt need.
The Applicant argues that the amendments have narrowed the claims to reflect the data shown in the instant specification (Remarks, pgs. 9-10).
Applicant’s argument is not found persuasive. Higher molecular weight and viscosity polyox is known in the art to have better swelling and gelling abilities, acting as a barrier in drug release studies (Shojaee, abs, pg. 1281). Therefore, it is unsurprising that a drug device in similar conditions, such as an aqueous system or passing through the gastrointestinal tract, would experience a similar effect related to the superior properties of a higher molecular weight or more viscous polymer.
Furthermore, the Applicant mentions the testing of certain polymers (Remarks, pg. 4), which shows comparative payout rates between Carbomer 971 (Figure 1) and Polyox 301 (Figure 2). The instant specification does not seem to demonstrate any further comparative data between the other polymers that the Applicant claims are capable of resisting ion concentration changes (Carbomer 980, Carbomer Ultrez 10, and Polyox 303). The range claimed for the molecular weight and viscosity is also too large for the Applicant to claim and assume that all of these non-ionic polyethylene oxide homopolymers with these broad molecular weights and viscosities would exhibit these same exact properties. Therefore, the data are not commensurate in scope with the claims. “For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
The Applicant argues that Green does not describe a sucrose fatty acid ester (Remarks, pg. 5).
Applicant’s argument is not found persuasive. The use of sucrose esters as an acceptable carrier in Green’s teaching is interpreted the same as a sucrose fatty acid ester (sisterna.com, pg. 1).
The Applicant argues that Green does uses polymers that are unable to resist the effects of changing ion concentrations (Remarks, pgs. 10-11).
Applicant’s argument is not found persuasive. Acceptable carriers in Green’s composition include sucrose esters (pg. 23) and hydroxymethyl cellulose (pg. 23), which is a gel former, as evidenced by the specification (para. 193), diluents include polyethylene glycol (other name: polyethylene oxide) (pg. 25) and wetting agents include acrylic acid or methacrylic acid polymers or copolymers (pg. 23). Polyethylene glycol or polyethylene oxide may have a molecular weight of over 20,000 g/mol or under 20,000 g/mol, respective (evidenced by sigmaaldrich.com, pg. 1), which is interpreted as addressing the broad molecular weight range limitation of claim 1.
The Applicant argues that Green does not describe any of the crosslinked anionic polymers (Remarks, pg. 11)
Instant claim 1 recites at least one polymer from the listed options. Green teaches a polyethylene oxide homopolymer with a molecular weight of over 20,000 g/mol, addressing the limitation.
The Applicant argues against the use of KSR to address the limitations in the instant claims (Remarks, pgs. 12-14).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
The Applicant argues that the polymer used with the beneficial agent would not mix with the polymer used in the expandable member (Remarks, pgs. 14-15).
Applicant’s argument is not found persuasive. Instant claim 1 recites “at least one matrix in the barrel.” Therefore, it is interpreted that the barrel may comprise multiple matrices and compartments.
The Applicant argues that Eckenhoff teaches a permeable wall (Remarks, pg. 16).
Applicant’s argument is not found persuasive. Eckenhoff teaches a wall that is at least a part permeable to the passage of fluid (claim 1), whereas the instant claim recites a body that is “substantially impervious,” which is interpreted that some fluid is capable of passing through.
The Applicant argues that Lubrizol does not teach that these polymers are suitable for veterinary applications (Remarks, pgs. 16-17).
Applicant’s argument is not found persuasive. Lubrizol is used as evidentiary evidence to teach that Carbopol 934P used in Eckenhoff’s teaching is an acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol. Lurizol’s teaching for oral administration is interpreted as addressing rumen administration. Additionally, Lubrizol 2005 teaches that Carbopol interpolymers (carbomer homopolymers or copolymers containing a block copolymer of polyethylene glycol and a long chain alkyl acid ester, pg. 3) provide benefits and advantages such as thickening efficiency, suspending capability, long viscous flow (pg. 8), and good controlled release properties (pg. 1).
The Applicant argues that Lubrizol does not provide any guidance to select the polymers to resist changes in cation concentrations (Remarks, pgs. 16-17).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant argues against the combination of references (Remarks, pgs. 17-19).
Applicant’s argument is not found persuasive. Since Eckenhoff does not explicitly teach a cross-linked anionic polymer comprising a block copolymer of polyethylene glycol and a long chain alkyl acid ester in claim 11 or a sucrose ester in claim 1, one of ordinary skill in the art would have been motivated to use a Carbopol interpolymer from Lubrizol’s teaching to address the deficiency in Eckenhoff, as Eckenhoff teaches various Carbopol components (Example 1, pg. 5, ln. 117). Additionally, Eckenhoff and Green teach intraruminal devices that are somewhat impermeable to fluids and can releast at least two active agents. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
The Applicant argues that the references teach away from the combination (Remarks, pgs. 19-20).
Applicant’s argument is not found persuasive. It is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)).
The Applicant argues that that improvement cannot be predicted if the problem was not even known (Remarks, 20-22).
Applicant’s argument is not found persuasive. An improvement can be obvious to a skilled artisan upon discovery of problem in the art. Since Green and Eckenhoff teach the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success. Furthermore, one of ordinary skill in the art would have been motivated to use a Carbopol interpolymer from Lubrizol’s teaching to address the deficiency in Eckenhoff, as Eckenhoff teaches various Carbopol components (Example 1, pg. 5, ln. 117). Additionally, Eckenhoff and Green teach intraruminal devices that are somewhat impermeable to fluids and can release at least two active agents. Generally, it is prima facie obvious to substitute or combine one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Conclusion
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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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613