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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 27, 2026 has been entered.
Election/Restrictions
To summarize the current election, the applicant elected Group I, without traverse.
Claims 36, 38, and 41-42 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The applicant notes the withdrawal of unelected subject matter which is interpreted as an affirmation of the election.
The election is deemed proper and therefore made FINAL.
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.
Claims 1, 3, 6-7, 13, and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the first functional group" and “the second functional group” in lines 12-13. There is insufficient antecedent basis for these limitations in the claim.
Claims not explicitly elaborated upon are also indefinite because they depend from a claim that is indefinite and do not add clarity. For the sake of application of prior art, the reactive functional groups of the recited trilysine and pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate succinimidyl glutarate will be deemed sufficient to meet the limitations of "the first functional group" and “the second functional group”. Clarification is still required.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1, 3, 6-7, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Jarrett et al. (previously cited).
Jarrett et al. teach an extended release drug delivery hydrogel composition that gels in situ and is envisioned for the eye (see abstract). Other deposition sites are envisioned and include a space or lumen inside a human (see paragraph 55). An example details an embodiment composed of water, 9 wt% 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate, 0.21 wt% trilysine, and a steroid active at about 2 wt% (see example 10; instant claims 1 and 29). These components are initially mixed at pH 4.5 to prevent reaction between the reactive terminal groups of the polyethylene glycol chains and the trilysine and then combined with sodium pentaborate to raise the pH and speed reaction (see paragraph 98). The mass of 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate and trilysine correspond to about 2.5 x 10-6 moles and about 2.1 x 10-6 moles, respectively (as calculated by the examiner). 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate has four first functional groups per molecule and trilysine has three second functional groups per molecule which corresponds to a first functional group to second functional group ratio of 1.12:1 (instant claim 1). In addition to the steroid active compounds listed in example 10, Jarrett et al. teach and exemplify dexamethasone as an additional steroid active for inclusion in their gel compositions (see paragraph 117 and examples 2-3). The concentrations employed for dexamethasone are 10 wt% and 20 wt% for examples 3 and 2, respectively. Jarrett et al. more generally teach that the reacting components of the gel are sensitive to pH such that reaction rates increase with pH beyond 4 to 7 (see paragraph 98). Various buffers to utilize toward this end are envisioned to include borate buffer which has a pH of 9 to 12 or triethanolamine buffer which has a pH of 7.5 to 9 (see paragraph 98). Jarret et al. further exemplify the amine-succinate gelation reaction to occur in a 6.8 pH aqueous mixture of the reactive gel components (see example 3; instant claim 1). Gelation is detailed to occur within 0.1 to 30 minutes (see paragraph 91). They additionally disclose that the elasticity of the polymer is increased with increasing polyethylene glycol chain units and point to molecular weight ranges of 2000 to 100,000 to reach this end which implies that the exemplified polymer has a degree of elasticity (see paragraph 90; instant claim 7). In addition, Jarrett et al. assess the release kinetics of a drug from the gel in pH 6.3 buffer and disclose release over more than 5 days which requires the gel to remain present for this duration (see paragraphs 33-34 and figure 11A; instant claim 3). Further, the gels are disclosed as swelling no more than about 50% upon exposure to physiological saline for 24 hours (see paragraph 92; instant claim 6). Pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate is not explicitly taught as the 4 arm polyethylene glycol succinimidyl glutarate of Jarrett et al.
Gravett et al. teach pharmaceutical hydrogels that may deliver drugs (see paragraphs 15-16). The hydrogels are composed of polyfunctional polymers, where 4-arm polyethylene glycol varieties are employed that are made from derivatizing pentaerythritol with polyethylene glycol chains of a desired length and terminated by a reactive functional group (see paragraphs 15-16 and 83). These polymers are pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate (see paragraphs 15-16 and 83; instant claim 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange dexamethasone for the triamcinolone acetonide in example 10 of Jarrett et al. in order to provide an alternative envisioned and exemplified corticosteroid. This choice would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Adjusting the proportion to a relevant level for the drug would follow and lead to various values such as the exemplified 10 wt% or 20 wt% and those between the about 2 wt% steroid loading of example 10 and the exemplified 20 wt% of dexamethasone in example 2. These proportions meet or generate a range that overlaps with the instantly recited range, thereby rendering the claimed range obvious. “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)” (see MPEP 2144.05). It also would have been obvious to make the composition of Jarrett et al., where their 4 arm polyethylene glycol succinimidyl glutarate is structured as pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate as taught by Gravett et al. This choice would have been obvious because Gravett al. teach pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate was a known particular structure for providing a 4 arm polyethylene glycol succinimidyl glutarate in a reactive pharmaceutical preparation. Regarding the pH of the prepared gel, the pH due to the presence of the sodium tetraborate (borate buffer) as exemplified would fall within the instantly claimed range (6.8) or would have been obvious to modify within the taught range so as to control the reaction rate as a matter of routine experimentation (see instant claim 5). Alternatively, the buffer would have been obvious to exchange for another envisioned variety, such as triethanolamine buffer, and would fall within the range of 4.5 and 9 which meets the instant claim limitations (see instant claim 5). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The gel composition rendered obvious by Jarrett et al. in view of Gravett et al. has all the instantly claimed components in the instantly claimed proportions and configurations, thus the instant functional limitations of gelation time, residence time in the middle ear, viscosity, and swelling at equilibrium would follow, absent evidence to the contrary. The recitation of the composition as “otic” is an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The compositions of Jarrett et al. are envisioned for (capable for) use in the eye as well as in a variety of body spaces and lumen, thus the composition rendered obvious by following their teachings is capable of being administered to the ear which is a body space and a lumen. Therefore claims 1, 3, 6-7, and 29 are obvious over Jarrett et al. in view of Gravett et al.
Claims 1, 3, 6-7, 13, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Jarrett et al. in view of Gravett et al. as applied to claims 1, 3, 6-7, and 29 above, and further in view of Ashton et al. (previously cited).
Jarrett et al. in view of Gravett et al. render obvious the limitations of instant claims 1, 3, 6-7, and 29. The osmolality of the gel composition intended for placement in the eye is not detailed (see abstract).
Ashton et al. teach a composition that provides corticosteroids via placement into the eye (see abstract). They teach that it is preferable to provide the composition with an osmolality of 200 to 400 mOsmol/kg (see paragraph 29; instant claim 13).
It would have been obvious to the artisan of ordinary skill in the art at the time of filing of the invention to make the composition of Jarrett et al. in view of Gravett et al. such that it has an osmolality as taught by Ashton et al. because it is desirable for compositions with the same utility. The result is a range that overlaps with that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 6-7, 13 and 29 are obvious over Jarrett et al. in view of Gravett et al. and Ashton et al.
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 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 6-7, 13, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/530028 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite an otic composition comprising an anti-inflammatory active agent; a polymer composition comprising pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate, trilysine, and water; wherein the polymer composition forms a gel. The proportions of components, pH ranges, gelation times and conditions, persistence duration, and osmolality in the copending claims meet or overlap with the ranges of the instant claims. The composition is recited by the copending claims to adhere to a mucosal surface. Dexamethasone is recited in the copending claims as the active agent. While a single lineage of claims does not fulfill each claim’s limitations, it would have been obvious to the artisan of ordinary skill in the art at the time of filing of the invention to select dexamethasone as the anti-inflammatory active agent and apply the proportions and parameters recited in the copending claims because they state to do so. The overlap amongst claimed ranges and those of the copending claims render the instant ranges obvious (see MPEP 2144.05). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The gel composition rendered obvious by the copending claims has all the instantly claimed components in the instantly claimed proportions and configurations, thus the instant functional limitations of swelling at equilibrium would follow, absent evidence to the contrary. Therefore claims 1, 3, 6-7, 13 and 29 are obvious over claims 1-15 of copending Application No. 19/530028 (reference application).
Claims 1, 3, 6-7, 13, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/463990 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite an otic composition comprising an anti-inflammatory active agent; a polymer composition comprising pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate, trilysine, and water; wherein the polymer composition forms a gel. The proportions of components, pH ranges, gelation times and conditions, persistence duration, and osmolality in the copending claims meet or overlap with the ranges of the instant claims. The composition is recited by the copending claims to adhere to a mucosal surface and to swell to the same degree under the same conditions as instantly recited. Dexamethasone is recited in the copending claims as the active agent. While a single lineage of claims does not fulfill each claim’s limitations, it would have been obvious to the artisan of ordinary skill in the art at the time of filing of the invention to select dexamethasone as the anti-inflammatory active agent and apply the proportions and parameters recited in the copending claims because they state to do so. The overlap amongst claimed ranges and those of the copending claims render the instant ranges obvious (see MPEP 2144.05). Therefore claims 1, 3, 6-7, 13 and 29 are obvious over claims 1-18 of copending Application No. 19/463990 (reference application).
Claims 1, 3, 6-7, 13, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/459988 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite an otic composition comprising dexamethasone; a polymer composition comprising pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate, trilysine, and water; wherein the polymer composition forms a gel. The proportions of components, pH ranges, gelation times and conditions, persistence duration, and osmolality in the copending claims meet or overlap with the ranges of the instant claims. The composition is recited by the copending claims to adhere to a mucosal surface and to swell to the same degree under the same conditions as instantly recited. While a single lineage of claims does not fulfill each claim’s limitations, it would have been obvious to the artisan of ordinary skill in the art at the time of filing of the invention to apply the proportions and parameters recited in the copending claims because they state to do so. The overlap amongst claimed ranges and those of the copending claims render the instant ranges obvious (see MPEP 2144.05). Therefore claims 1, 3, 6-7, 13 and 29 are obvious over claims 1-17 of copending Application No. 19/459988 (reference application).
Declaration
The declaration under 37 CFR 1.132 filed April 27, 2026 is insufficient to overcome the rejection of claims 1, 3, 6-7, 13, and 29 based upon Jarret et al. in view of Gravett et al. as set forth in the last Office action because: the showing is not commensurate in scope with the claims and does not show an unexpectedly superior outcome for the claimed composition.
The showing does not state that the 4ARM PEG SG is the instantly claimed pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate. Thus it is not clear that the tested polymer is the instantly claimed polymer and representative of the claimed composition.
Even if the tested polymer is a claimed pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate that is crosslinked by trilysine, the data shown by the declarant only demonstrates a different in release kinetics amongst four compounds released from the gel. Since the four test compounds are different, one would expect them to have some difference in their release kinetics. Jarrett et al. provide a 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate crosslinked with tryline that releases triamcinolone acetonide. The declarant tests this compound as well the claimed dexamethasone which Jarrett et al. also envisioned as an included drug. The declarant notes that the triamcinolone acetonide releases slower than the dexamethasone and assert that the triamcinolone acetonide pace would not yield a “physiological concentration” over the duration of the release window. There are no claim limitations concerning a particular amount of drug released over a particular duration, thus the relevance of the differences in release kinetics to the claims is not clear. The declarant also assessed the release of acetonide and from the hydrogel, but their relevance the obviousness of selecting dexamethasone for release also is unclear, given that no release kinetics are claimed and triamcinolone acetonide is a closer comparison in light of the prior art. There also is no evidence that the range of drug concentrations taught by Jarrett et al. within the claimed range would be insufficient to provide a “physiological concentration”. In addition, there is no evidence that the difference between the dexamethasone and triamcinolone acetonide release rates is unexpected to a significant degree. MPEP 716.02 details that “[a]ny differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).” Further, [t]he evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance" (see MPEP 716.02(b)). The declarant has not met any of these criteria to establish that the claimed invention has unexpected results that are demonstrative of non-obviousness.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments filed April 27, 2026 have been fully considered. In light of the amendment to the claims, the rejections are slightly modified. However, the arguments against the rejections are not persuasive.
The applicant argues that Jarrett et al. teach a number of drugs and that there is no reason to select dexamethasone from amongst their listing. While Jarrett et al. teach a number of drugs for inclusion, any one of them would be obvious to select because they are explicitly named and envisioned for this compositions. The variety of drugs that are envisioned point to the broad applicability of the composition of Jarrett et al. as a delivery vehicle. Moreover, dexamethasone is also exemplified and highlighted repeatedly by Jerrett et al. as a drug of interest for inclusion in their gel composition (see examples 2-3 and 11). Further, it is in the same class of steroid compound as those exemplified in the 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate embodiments taught by Jarrett et al. amongst the broader listing they teach (see paragraph 117 and example 10). Thus in contrast to the applicant’s argument, Jarrett at al. repeatedly highlight dexamethasone for inclusion in their composition and its selection would have been obvious.
The applicant appears to argue that the only viable path to the combination of teachings in a prima facia case of obviousness is a teaching, suggestion, or motivation (TSM) explicitly provided by one of the source references. MPEP 2141(I) details that a reliance solely upon a TSM rationale is overly rigid and does not serve as the only route to a case of obviousness. Here the rationale based upon simple substitution of one known element for another to obtain predictable results, was employed to support the prima facia case of obviousness. This line of reasoning is explicitly detailed as a viable path to building a prima facie case of obviousness (see MPEP 2141(III)).
The applicant additionally argues that Jarrett et al. lacks focus such that one would not select a trilysine crosslinker in combination with a 4-arm polyethylene glycol succinimidyl glutarate to produce an embodiment of the instantly composition. Again, Jarrett et al. exemplify the combination, in addition to including it amongst their general teachings. The artisan of ordinary skill has good reason to make any pairing of first and second precursor which provide a crosslinked hydrogel based on the teachings of Jarrett et al. and particularly those that are exemplified in combination.
The applicant argues that Gravett et al. expand the possibilities of active agents that could be includes in in situ gelling hydrogels of Jarrett et al. which they apparently deem makes any selection untenable. To the contrary, Gravett et al. further specify the chemical structure of 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate that form such materials and their teachings of drug options do not negate or outweigh the exemplary and repeated teachings of Jarrett et al. Since the 4-arm 20,000 molecular weight polyethylene glycol succinimidyl glutarate of Jarrett et al. must have some sort of core from which its four arms extend, the erythritol core of Gravett et al. is a logical choice, given its similar utility. Since such elaboration on the core is required in order to select a compound to make the exemplified hydrogel vehicle of Jarrett et al., the artisan would have good reason to “zero in” in this compound amongst those taught by Gravett et al. There is no requirement that the artisan must also choose a drug from Gravett et al. in order to glean from its teachings that further specify more generic teachings of Jarrett et al. Moreover, dexamethasone is also taught by Gravett et al. which further supports the suitability of dexamethasone as a choice for inclusion in a pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate hydrogel.
In contrast to the applicant’s argument, the rejection explicitly sets forth multiple reasons for why the artisan would make the selections highlighted from the teachings of Jarrett et al. and Gravett et al. (e.g., exemplary compounds and obvious substitution of known alternatives amongst named exemplified compounds of the same class). Further there is no evidence of record of the criticality of any claimed component. Thus the evidence of record supports the prima facie case of obviousness that has been set forth.
The applicant argues that the claimed product has unexpected results. The result they highlight is about a particular method of use of an instantly claimed embodiment as compared to an unclaimed drug. This showing does not show an unexpected outcome due to any claimed feature as compared to the closest prior art. The efficacy of a particular treatment modality as compared to another (e.g., drug A vs drug B or vehicle X vs. vehicle Y, etc.) can be relevant to a claimed method of treatment. However, the instant claims under examination recite a product and such comparisons do not speak to the obviousness of the modification that the rejection makes to the prior art product. The applicant asserts that the pharmacokinetic benefit of the claimed composition is unexpected as compared to a different drug, when they are administered intratympanically to the ear. No vehicle is described for the comparative drug. Whatever difference may occur between these treatments says nothing about the obviousness of making the claimed composition. The instant recitation of the composition as “otic” is an intended use and does not constrain the actual utility to this region. Thus that methods of use of the composition as compared to another composition with which it shares few, if any, common features does not impact the obviousness of constructing the claimed composition..
The applicant asserts that the claimed composition possesses unexpected properties in its lessened impact on hearing loss when intratympanically injected. The applicant has not provided any evidence of the expected outcome. Therefore they have no basis to conclude the outcome they attained was unexpected. Further, the unexpected result has to occur due to the difference between the prior art and the claimed composition in order to be persuasive and there is no indication of which aspect of the claimed composition is responsible for the property that was seen. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The applicant goes on to reiterate the discussion provided in the declaration. The declaration was addressed in the Declaration section above and the response is similarly reiterated. The applicant also characterizes the release of the gel of Jarrett et al. with triamcinolone acetonide as “incomplete”, but the composition’s release of triamcinolone acetonide was only measured for 2 weeks and did not indicate a plateau had been reached. Thus the basis of this characterization of the declaration by the applicant is unclear. The applicant argues that the testing of a collection of steroid compounds was intended to demonstrate that they do not all perform the same. Since the compounds are different, some variation is expected. Given that there are no claim limitations concerning released amounts or duration of dexamethasone release and neither the declarant nor the applicant has established that the difference between the triamcinolone acetonide and dexamethasone is significant and unexpected, the showing is insufficient to overcome the prima facia case of obviousness.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights