DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
A new claim set was filed on 3/27/26 with the following:
Amended claims
1, 3-6, 8-9, 14
Newly canceled claims
2, 7
Newly added claims
Previously canceled claims
Previously withdrawn claims
18-23
Claims under instant examination
1, 3-6, 8-17
Withdrawn Claim Objections/Rejections
All rejections pertaining to claims 2 and 7 are moot because the claims were cancelled in view of the amendments filed on 3/27/26.
The duplicate claim warning to claims 6-7 is hereby withdrawn in view of the claim amendments filed on 3/27/26.
The rejections of:
claims 1, 10, 13-15 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Tada et al. (US 2016/0271057; published: 9/22/16)
are hereby withdrawn in view of the claim amendments filed on 3/27/26; specifically adding previous claim 2 limitations to independent claim 1.
Maintained and Modified 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 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, 3-5, 10-11, 13-15 and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (US 2016/0271057; published: 9/22/16; of record) and as evidenced by Heath (US 2017/0027168; published: 2/2/17; of record).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Examiner’s note: As indicated in MPEP 2111.03, the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48USPQ2d at 1355. The instant specification fails to specify materials or steps that do not materially affect the basic and novel characteristics of the claimed invention, and is further devoid of the term “consisting essentially of”. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964).
Tada et al. is directed to an aqueous suspension preparation that comprises a macrolide antibacterial agent as an active component, wherein the aqueous suspension preparation is characterized by comprising nanoparticles of a macrolide antibacterial agent and a dispersion stabilizer; an aqueous suspension in which the average particle size of nanoparticles is 500 nm or less (Abstract).
With regards to instant claims 1 and 14, Tada et al. teach an aqueous suspension formulation comprising nanoparticles of a macrolide antibiotic (i.e., pharmaceutically active agent), wherein the nanoparticles have an average particle diameter of 500 nm or less (overlaps with the claimed range) (see claims 1-2). Tada et al. teach that the average particle diameter preferably 200nm or less ([0023]). Tada et al. teach that the aqueous suspension formulation further comprises a dispersion stabilizer such as a viscosity modifier and wherein the viscosity modifier is hydroxypropyl methyl cellulose (i.e., a viscous cellulose ether) (See claims 5-6 and 9). Tada et al. teach that the surfactant can modify the surface of nanoparticles of the macrolide antibiotic ([0042]). Tada et al. teach wherein the formulations include ocular topical formulations for treating or preventing inflammatory diseases or infectious diseases of eye ([0029]). Tada et al. teach wherein the aqueous suspension formulation further comprises an aggregation inhibitor such as lecithin and a surfactant such as polysorbate 80 (See claims 5-8). With regards to the claimed cation (e.g., cetylpyridinium halide, cetrimonium halide, cetalkonium halide or mixtures thereof), Tada et al. teach that cetyl pyridinium bromide can behave as a surfactant in the abovementioned formulation and that one, two or more surfactants may be added to the formulation ([0038]). Tada et al. also teach that cetyl pyridinium bromide behaves as a preservative and disinfectant ([0099]).
With regards to instant claim 3, Tada et al. teach wherein the aggregation inhibitor is lecithin (e.g., purified soybean lecithin) ([0039] and claims 5-6 and 8). As evidenced by Heath, lecithin is a dietary supplement and generic term to designate any group of yellow-brownish fatty substances occurring in animal and plant tissues composed of phosphoric acid, choline, fatty acids, glycerol, glycolipids, triglycerides, and phospholipids (e.g., phosphatidylcholine, phosphatidylethanolamine, and phosphatidylinositol ([0288]). Tada et al. teach that the aggregation inhibitor inhibits the aggregation of a macrolide antibiotic, can be administered to human without toxicity and does not prevent an activity of the macrolide antibiotic ([0039]).
With regards to instant claim 4, Tada et al. teach wherein 44 g of an aqueous 0.1% Tween 80 (i.e., polysorbate 80) is added to 0.5 g of clarithromycin kneaded product to form the formulation.
With regards to instant claims 10-11, Tada et al. teach that the aqueous suspension formulation further comprises a dispersion stabilizer such as a viscosity modifier and wherein the viscosity modifier is hydroxypropyl methyl cellulose (See claims 5-6 and 9).
With regards to instant claim 13, Tada et al. teach that the pH is not particularly limited as long as they are within the extent acceptable for the topical formulations; preferably 5-9.5 and more preferably 6-9 ([0097]).
With regards to instant claim 15, Tada et al. teach wherein the pharmaceutically active agent is a macrolide antibiotic (See claims 1-2).
With regards to instant claim 17, Tada et al. teach a formulation comprising 0.1 wt% clarithromycin (Examples; e.g., Example 2).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Tada et al. teach that cetylpyridinium bromide or chloride is an option for the surfactant in the abovementioned formulation, they do not teach a particular embodiment wherein the formulation comprises cetylpyridinium bromide or chloride combined with the other claimed components, as required by instant claim 1.
Although Tada et al. teach that lecithin is an option for the aggregation inhibitor in the abovementioned formulation, they do not teach the concentration of about 0.1-0.5% by weight of the total weight of the ophthalmic suspension base (w/w), as required by instant claim 3.
Although Tada et al. teach that cetylpyridinium chloride is an option for the surfactant in the abovementioned formulation, they do not teach the concentration of about 0.002% by weight of the total weight of the ophthalmic suspension base (w/w), as required by instant claim 5.
Although Tada et al. teach that hydroxypropyl methylcellulose is the viscosity modifier in the abovementioned formulation, they do not teach the concentration of about 0.2-1.1% by weight of the total weight of the ophthalmic suspension base (w/w), as required by instant claim 11.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on the teachings of Tada et al., it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the formulation of Tada et al. by selecting cetylpyridinium bromide from the list of taught surfactants to achieve the predictable result of obtaining a composition suitable for treating inflammation in ocular diseases. One of ordinary skill in the art would have been motivated to do so because Tada et al. teach that cetylpyridinium bromide also advantageously behaves as a preservative and disinfectant ([0099]).
The amount of lecithin, cetylpyridinium chloride and hydroxypropyl methylcellulose is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of lecithin, cetylpyridinium chloride and hydroxypropyl methylcellulose in order to best achieve the desired results as such would provide advantageous biological effect. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Tada et al. teach that the aggregation inhibitor (e.g., lecithin) inhibits the aggregation of a macrolide antibiotic, can be administered to human without toxicity and does not prevent an activity of the macrolide antibiotic ([0039]). Tada et al. teach that cetylpyridinium chloride behaves as a surfactant, preservative and disinfectant in the formulation ([0038], [0099]) and that hydroxypropyl methylcellulose behaves as a viscosity modifier ([0040]). Tada et al. also show the influence of thickeners, wherein the results suggested that hydroxypropyl methylcellulose exceled as a thickener ([0132]). The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of lecithin, cetylpyridinium chloride and hydroxypropyl methylcellulose would impact the aggregation of macrolide antibiotic, surface modification of the nanoparticles in the formulation and the viscosity of the formulation and therefore be an optimizable variable.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (US 2016/0271057; published: 9/22/16; of record) and Heath (US 2017/0027168; published: 2/2/17; of record) as applied to claims 1, 3-5, 10-11, 13-15 and 17 above, and in further view of Labhasetwar (US 2022/0193310; published: 6/23/22; of record).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Tada et al. anticipates claims 1, 10, 13-15 and 17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Tada et al. for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Tada et al. teach or make obvious the limitations of instant claims 1-2, 4-5, 10-11, 13-15 and 17 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Tada et al. teach that the cationic surfactant can be alkyl quaternary ammonium salts, they do not teach the species, cetrimonium bromide, as required by instant claims 6-7 or cetalkonium chloride, as required by instant claim 8. However, such deficiency is cured by Labhasetwar.
Labhasetwar is directed to pharmaceutical composition comprising polymeric nanoparticles comprising a first and second therapeutic agent (Abstract). Labhasetwar teaches the use of cationic surfactants in its nanoparticles. Labhasetwar teaches that cetrimonium bromide, cetalkonium chloride and cetylpyridinium chloride are acceptable cationic surfactants ([0056]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional cationic surfactants (e.g., cetrimonium bromide and cetylpyridinium chloride) used in nanoparticles. It would follow that the recited claims define prima facie obvious subject matter. (See MPEP 2144.06).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (US 2016/0271057; published: 9/22/16; of record) and Heath (US 2017/0027168; published: 2/2/17; of record) as applied to claims 1, 3-5, 10-11, 13-15 and 17 above, and in further view of Rabinovich-Guilatti et al. (US 2008/0026991; published: 1/31/08; of record).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Tada et al. anticipates claims 1, 10, 13-15 and 17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Tada et al. for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Tada et al. teach or make obvious the limitations of instant claims 1-2, 4-5, 10-11, 13-15 and 17 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Tada et al. do not teach wherein the nanoparticles further comprise substantially equal amounts of heavy and light mineral oil having a concentration of about 0.5% by weight of the total weight of the ophthalmic suspension base (w/w), as required by instant claim 9. Tada et al. do not teach wherein the nanoparticles comprise a nanoemulsion, as required by instant claim 12. However, such deficiency is cured by Rabinovich-Guilatti et al.
Rabinovich-Guilatti et al. are directed to compositions containing quaternary ammonium compounds (e.g., cetalkonium chloride – [0020]) used in ophthalmic oil-in-water emulsions, being useful for eye care or for the treatment of eye conditions (Abstract). Rabinovich-Guilatti et al. teach that in ophthalmic ointments, mineral oil can be found as excipient at concentrations of up to 60% ([0054]). And furthermore, Rabinovich-Guilatti et al. teach that a combination of light and heavy mineral oil in ophthalmology has been recognized by the US authorities as bearing emollient properties particularly adapted to dry eye treatment (e.g., after LASIK) ([0032], [0054]). It is noted that Tada et al. teach that its ophthalmic formulations can be topically applied such as in the form of an eye drop to treat eye diseases such as keratitis, particularly post-LASIK ([0006]). Rabinovich-Guilatti et al. teach that its oil-in-water emulsion formulations presents the advantages to be very stable and non-toxic ([0025]). Rabinovich-Guilatti et al. teach wherein the oil phase preferably comprises mineral oil, preferably 1-5%, based on the weight of the emulsion, wherein the mineral oil is a mixture of heavy and light mineral oil (50/50) ([0051]-[0054]). It is noted, that Rabinovich-Guilatti et al. use the same surfactants as Tada et al. (e.g., polysorbate 80) ([0055]) and states that in a second embodiment, the composition contains an active principle ([0067]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Tada et al. and Rabinovich-Guilatti et al. are both directed to formulations comprising quaternary ammonium compounds (e.g., cetalkonium chloride), active agents and polysorbate for use in treating ophthalmic diseases/disorders. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the aqueous suspension of macrolide nanoparticles by further incorporating heavy and light mineral oil to form a nanoemulsion to achieve the predictable result of obtaining a composition suitable for treating ophthalmic diseases/disorders. One of ordinary skill in the art would have been motivated to do so because Rabinovich-Guilatti et al. teach that a combination of light and heavy mineral oil in ophthalmology has been recognized by the US authorities as bearing emollient properties particularly adapted to dry eye treatment (e.g., after LASIK) ([0032], [0054]), which provides an advantage (i.e., motivation for one of ordinary skill in the art to incorporate such in ophthalmic formulations). Furthermore, the incorporation of mineral oil will help to modify the aqueous suspension of macrolide nanoparticles taught by Tada et al. into a nanoemulsion, which was taught by Rabinovich-Guilatti et al. to be advantageously stable and non-toxic ([0025]).
Regarding the concentration of mineral oil as specified in claim 9, MPEP 2144.05 states:
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).
Furthermore, Rabinovich-Guilatti et al. teach wherein the oil phase preferably comprises mineral oil, preferably 1-5%, based on the weight of the emulsion, wherein the mineral oil is a mixture of heavy and light mineral oil (50/50) ([0051]-[0054]). It is noted that there is no teaching un Rabinovich-Guilatti et al. that concentrations outside of this range would not work. Furthermore, the Applicants' specification provides no evidence that the selected concentration range in claim 9 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous physical/chemical/biological properties of various chemicals (e.g., amount of active agent being delivered to eye, amount of other oils in the oil phase), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine these teachings and alter the concentration. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be suitable to form a formulation usable to treat ophthalmic diseases/disorders.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (US 2016/0271057; published: 9/22/16; of record) and Heath (US 2017/0027168; published: 2/2/17; of record) as applied to claims 1, 3-5, 10-11, 13-15 and 17 above, and in further view of Mohan (US 2021/0128526; published: 5/6/21; of record)
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Tada et al. anticipates claims 1, 10, 13-15 and 17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Tada et al. for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Tada et al. teach or make obvious the limitations of instant claims 1-2, 4-5, 10-11, 13-15 and 17 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Tada et al. teach wherein its formulations include ocular topical formulations for treating or preventing inflammatory diseases or infectious diseases of eye ([0029]), but they do not teach wherein the pharmaceutically active agent is a nonsteroidal anti-inflammatory agent, as required by instant claim 16. However, such deficiency is cured by Mohan.
Mohan is directed to eye drops to treat chemically induced corneal damage (Title). Mohan teach that NSAIDs block COX enzymes and inhibit ocular pain, inflammation, burning, and stinging in eye ([0082]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (clarithromycin + NSAID for the purpose of providing anti-inflammatory properties to the eye), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06-I).
Alternatively, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (clarithromycin with NSAID for the purpose of providing anti-inflammatory properties to the eye) (See MPEP 2144.06-II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Response to Arguments
Applicants’ arguments have been fully considered, but are not found persuasive.
Applicants argue that Tada neither discloses nor suggests nanoparticles having a positive surface charge (Remarks: p. 7).
This is not found persuasive. In response, it is first noted that the instant claims recite “a plurality of positively charged nanoparticles…”; that is, they do not specifically require the surface to be positively charged, as argued throughout the Remarks. Secondly, as indicated in the instantly maintained/modified 103 rejection, Tada teaches wherein the composition comprises “nanoparticles of a macrolide antibacterial agent and a dispersion stabilizer” and furthermore, wherein the macrolide is, for example, erythromycin or clarithromycin. Erythromycin and clarithromycin are a known macrolide antibiotics with a positive (cationic) charge at physiological pH.
Applicants argue that Tada neither discloses nor suggests incorporation of such particles into a viscous cellulose-derived base for ophthalmic use (Remarks: p. 7).
This is not found persuasive. In response, and as indicated in the instant 103 rejection, Tada et al. teach that the aqueous suspension formulation further comprises a dispersion stabilizer such as a viscosity modifier and wherein the viscosity modifier is hydroxypropyl methyl cellulose (i.e., a viscous cellulose ether) and that the formulations include ocular topical formulations for treating or preventing inflammatory diseases or infectious diseases of eye ([0029]). Such two teachings read on the viscous cellulose-derived base for ophthalmic use. In fact, this is the same cellulose as instant claimed in claims 10-11 (i.e., HPMC).
Applicants argue that Tada is entirely silent regarding nanoparticle surface charge, electrostatic dispersion, or prolonged ocular residence time, which are central to the present invention (Remarks: p. 7).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., nanoparticle surface charge, electrostatic dispersion, or prolonged ocular residence time) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants argue that Labhasetwar is directed to polymeric nanoparticles for systemic pharmaceutical delivery and does not address ophthalmic suspension bases, cellulose-derived viscous vehicles or ocular retention (Remarks: p. 7). Applicants argue that Rabinovich-Guilatti et al. do not disclose nanoparticles, nanoparticle surface charge as a mechanism for dispersion and do not suggest replacing oil-based emulsion with the claimed nanoparticle based- suspension architecture (Remarks: p. 8). Applicants argue that Mohan does not disclose nanoparticle formulations, positively charged nanoparticles, or viscous cellulose-derived ophthalmic bases (Remarks: p. 8).
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). Since the instant rejection is an obviousness-type rejection, none of the references (i.e., Tada and Labhasetwar; Tada and Rabinovich-Guilatti et al.; and Tada and Mohan) has to teach each and every claim limitation. It is the combination of the prior art references that renders the instant claims prima facie obvious and applicants did not provide any evidence that one of skill in the art would not have been motivated or would not have reasonably expected to be successful in arriving at the claimed invention as set forth in the rejection above. Such is especially the case, when the Applicants have not provided any unexpected results that obviate the prima facie case of obviousness.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks: p. 7-8), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicants argue that the cited references fail to provide any teaching or suggestion that lecithin, a polysorbate and a cation selected from the group consisting of a cetylpyridinium halide, a cetrimonium halide, a cetalkonium halide, or mixtures thereof are capable of forming nanoparticles in the absence of a macrolide antibiotic or a biopolymeric core material (Remarks: p. 10).
This is not found persuasive. In response, the claims do not require that the nanoparticles are free of macrolide antibiotic or a biopolymeric core material. The Examiner emphasizes the transitional phrase “comprises” after “…wherein the nanoparticle…” and therefore, it is open-ended.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
Prosecution Insights