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 .
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 29 June 2026 are acknowledged and have been fully considered. Claims 1-4, 9-11, 13-15, 18-20, 23-24, 31-32, and 34 are pending. Claims 1-4 and 9 are under consideration in the instant office action. Claims 10-11, 13-15, 18-20, 23-24, 31-32, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01 December 2025. Claims 5-8, 12, 16-17, 21-22, 25-30, and 33 are canceled. Applicant’s claim amendments and arguments did not overcome the rejections under 35 USC 103 for reasons set forth in the previous office action and herein below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained and Restructured-Necessitated by Amendments
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.
Note: The claims are examined with respect to the elected species as follows:
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Claims 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kameni et al. (WO2021/016305, previously provided) in view of Momoi (US2009/0304601, previously provided) and Goethals et al. (EP3928996, previously provided).
Note: The claims are examined with respect to the elected species set forth below:
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Applicants’ claims
Applicants claim a softgel capsule comprising: a fill material; and a shell composition, wherein the shell composition comprises a marking formulation including a marking component, wherein laser irradiation is applied to the softgel capsule at a wavelength of greater than 1100 nm to about 2200 nm, causing the marking component to provide a visible effect, wherein the formulation does not include titanium dioxide. Dependent claims thereof recite limitations further defining features.
Claim Interpretation: Applicant in the specification paragraph 0093 discloses “Several sample softgel capsules were prepared using a variety of marking formulations which were tested using a fiber laser. In each example capsule, glycerol, purified water, and gelatin were combined with a marking formulation according to Table 1.” In Table 1 Samples 1-4 recite marking formulations of different iron oxide pigments. The broadest reasonable interpretation includes the capsule shell contains the capsule making ingredients and the marking composition.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Kameni et al. teach softshell capsule formulation, comprising: a synthetic polymer; a natural gelling agent; a buffering agent; a plasticizer; and water (see claim 1). The softshell capsule formulation of claim 1, wherein the synthetic polymer comprises at least one of a poly(N-vinyl lactam), povidone, crospovidone, a maleic anhydride copolymer, poly(2-ethyl-2-oxazoline), poly(ethyleneimine), polyurethane hydrogelsan acrylic acid polymer, a methacrylic acid polymer, methyl acrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate, aminoethyl acrylate, maleic anhydride, polymaleic acid, a polyacrylamide, poly(methacrylamide), poly(dimethylacrylamide), poly(N-isopropyl acrylamide), a polyolefmic alcohol, poly(N-vinyl caprolactam), a polyol, glycerol, polyglycerol, propylene glycol, polyoxyethylated sorbitol, polyoxy ethylated glucose, a polyoxazoline, poly(methyloxazoline), poly(ethyloxazoline), a polyvinylamine, a polyvinylacetate, polyvinyl acetate, polyvinyl acetate phthalate, a polyimine, polyethyleneimine, a polyurethane hydrogel, chitosan, a polysaccharide gum, zein, shellac, ammoniated shellac, shellac acetyl alcohol, shellac n-butyl stearate, esters thereof, homopolymers thereof, copolymers thereof, block copolymers thereof, graft copolymers thereof and combinations thereof (see claim 2). The softshell capsule formulation of claim 1 or 2, wherein the synthetic polymer comprises povidone (see claim 3). The softshell capsule formulation of claim 1, wherein the natural gelling agent comprises at least one of carrageenan, xanthan gum, agar agar or pectin, sugar, sugar derived alcohol, starch, pregelatinized starch, a cellulose derivative, a cellulosic polymer, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, microcrystalline cellulose, attapulgite, bentonite, dextrin, alginate, kaolin, lecithin, magnesium aluminum silicate, carbomer, carbopol, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, silicon dioxide, curdlan, furcelleran, egg white powder, lacto albumin, soy protein, chitosan and sodium laurel sulfate (see claim 4). The softshell capsule formulation of claim 1, wherein the buffering agent comprises at least one of dibasic sodium phosphate, monobasic sodium phosphate, sodium bicarbonate, sodium citrate, disodium phosphate, calcium phosphate, dibasic calcium phosphate, tribasic calcium phosphate, monobasic potassium phosphate and dibasic potassium phosphate (see claim 8). The softshell capsule formulation of claim 1, wherein the buffer agent comprises dibasic sodium phosphate (see claim 9). The softshell capsule formulation of claim 1, wherein the plasticizer comprises at least one of glycerin, glycerol, adonitol, sorbitol, sorbitol blend, ribitol, galactitol, D- galactose, 1,3-dihydroxypropanol, glucose, sucrose, mannitol, xylitol, meso-erythritol, adipic acid, proline, hydroxyproline, polyol compound, monoglyceride, short- or medium-chain free fatty acid, monoacylglycerol ester, low molecular weight polymer, oligomer, copolymer, oil, small organic molecule, low molecular weight polyol having aliphatic hydroxyl, glycol ethers, polypropylene glycol), multi-block polymer, single block polymer, low molecular weight poly(ethylene glycol), citrate ester-type, triacetin, propylene glycol, ethylene glycol, 1,2-butylene glycol, 2,3 -butylene glycol, styrene glycol, di ethylene glycol, tri ethylene glycol, tetraethylene glycol, monopropylene glycol monoisopropyl ether, propylene glycol monoethyl ether, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, sorbitol lactate, ethyl lactate, butyl lactate, ethyl glycolate, dibutyl sebacate, acetyl tributyl citrate, triethyl citrate, acetyl triethyl citrate, tributyl citrate and allyl glycolate (see claim 10). The softshell capsule formulation of claim 1, wherein the plasticizer comprises glycerin (see claim 11). The softshell capsule formulation of claim 1, further comprising at least one of a colorant, opacifier, flavorant, sweetener, preservative, embrittlement inhibiting agent and disintegrant (see claim 12). The softshell capsule formulation of claim 12, wherein the colorant comprises at least one of an azo dye, quinophthalone dye, triphenylmethane dye, xanthene dye, iron oxide, iron hydroxide, titanium dioxide, sunset yellow, allura red, amaranth, koki neil red, azogeranin, tartrazine, brilliant black, canthaxanthin, patent blue, fast green, brilliant blue, acid green, erythrosine, quinoline yellow, indigotin, curcumin, carbon black and combinations thereof (see claim 13). The examiner notes that one can pick the iron oxide from the Markush list meeting the limitations of claims 6-7. The softshell capsule formulation of claim 1, wherein the softshell capsule formulation is free of at least one of gelatin and starch (see claim 26). In certain embodiments, the softshell capsule formulation is free of at least one of gelatin and/or starch (paragraph 0023). The examiner notes that gelatin can be incorporated.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Kameni et al. do not specifically teach wherein laser irradiation is applied to the softgel capsule at a wavelength of greater than 1100 nm to about 2200 nm, causing the marking component to provide a visible effect, wherein the formulation does not include titanium dioxide. Additionally, Kameni et al. do not specifically teach wherein the laser irradiation is achieved using a fiber laser. These deficiencies are cured by the teachings of Momoi and Goethals et al.
Momoi teaches a marking method that is highly productive and enables production of easily-identifiable compositions for use in oral administration such as drugs and foods without damaging the quality of the oral composition. The marking method according to the present invention is a method for marking such a composition for use in oral administration and includes the steps of: dispersing a change in color-inducing oxide in the composition for use in oral administration; and scanning a surface of the composition for use in oral administration with a laser beam at wavelengths of from 200 nm to 1100 nm and with from 0.1 W to 50 W average power in to make the particles of the change in color-inducing oxide agglomerate so as to become discolored. The change in color-inducing oxide used in the present invention is at least one selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide (see abstract). The examiner notes that one can pick the iron oxide from the Markush list. Regarding the laser irradiation wavelength of greater than 1100 nm to about 2200 nm, first Momoi’s teaching of 1100 nm is close enough to greater than 1100 nm, it is expected to work similarly. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Momoi teaches in a preferred embodiment of the manufacturing method according to the present invention, there is provided a method for manufacturing a composition for use in oral administration, including the steps of: obtaining a composition for use in oral administration, which has a coating layer in which at least one type of change in color-inducing oxide selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide, is dispersed; and making an identification mark by scanning a surface of the coating layer with a laser beam at wavelengths of from 200 nm to 1100 nm and with from 0.1 W to 50 W average power. The coating layer may comprise any of titanium dioxide, yellow ferric oxide, and red ferric oxide, but there is no particular limitation on combinations of these oxides or any other components. Specific examples of the coating layer include capsule coating layers, film-coated layers, and sugar-coated layers. The dosage forms of the composition for use in oral administration in a preferred embodiment of the present invention are: film-coated tablets, sugar-coated tablets, hard capsules, and soft capsules (paragraph 0018). Momoi teaches with regard to pharmaceutical compositions for use in oral administration such as tablets and capsules, not only their packages, but also the compositions themselves are required to be identifiable in order to prevent mistakenly dispensing or taking the wrong drugs. However, there are limitations to identifying tablets and capsules with only their shapes and color tones. Therefore, marks are made on the surface of tablets and capsules in order to enhance identifiability. For example, the following methods are employed for marking tablets and capsules: transfer-type printing using a rubber roller to directly print letters and the like on a the surface of film-coated tablets and capsules; and inkjet-type printing of printing ink dots on the surface of film-coated tablets or capsules. In the case of uncoated tablets, a method for imprinting tablets, using a tableting punch with a concave-convex surface, has been employed since old times (paragraph 0002). However, these classic methods like the transfer-type printing are easily affected by, for example, the surface condition of tablets or capsules and the atmosphere where the printing is carried out. Accordingly, very complicated management is required in order to stably provide clear printing. Also, in the case of inkjet-type printing, insufficient drying of ink causes stains, or blurring of the printed letters on the tablets, which may have an influence on the appearance of the tablets. Furthermore, in the case of imprinting, tablets and capsules have spherical surfaces in many cases and, therefore, there are limitations on the area on the tablet surface where letters and the like can be printed, and the number and size of letters or the shapes of graphic symbols that can be printed on the tablet surface. Consequently, the amount of information provided by the marked tablets is not always sufficient. Also, imprinting requires an exclusive punch for each product. Moreover, depending on the shape of the engraved mark, sticking may easily occur, resulting the engraved part being chipped off; and the engraved part may also wear off in the post-tableting step as well, which will cause an increase in the defect rate in an appearance examination. The engraved part may also chip off in the distribution process, which may not only decrease identifiability, but also have an influence on the product quality (paragraph 0003). Therefore, there is a strong need for development of a marking method unlike the conventional marking methods, which is highly productive and which enables production of easily-identifiable compositions for use in oral administration such as drugs and foods without damaging the quality of the compositions for use in oral administration (see paragraph 0009). As a result of thorough research of a method for marking the compositions for use in oral administration in light of the circumstances described above, the inventor of the present invention have found that irradiation of the surface of a composition for use in oral administration, in which a specified change in color-inducing oxide is dispersed, with a specified laser beam causes change in color of the surface due to agglomeration of the change in color-inducing oxide. As a result of this agglomeration phenomenon, the present inventor has completed the present invention (see paragraph 0010).
Goethals et al. teach a method of marking an article (1) comprising a marking step wherein the article (1) including a first (100) and a second (200) colour-forming layer provided on at least part of a support (500), each colour-forming layer capable of forming respectively a first and a second colour upon marking, is marked thereby forming an image (350, 350'), characterized in that first and the second colour are formed simultaneously in at least part of the marking step (see abstract). Another advantage of using laser marking or thermal printing instead of another printing technique, such as inkjet printing, is the absence of any chemicals in the marking process. Especially for pharmaceutical and food packaging, the absence of chemicals in the packaging line is an advantage (paragraph 0155). The laser can be a solid state laser, such as a disk laser, a Nd:Yag laser or a Fiber laser. The laser can be a gas laser, such as a He-Ne laser, a CO2-laser, or an Excimer laser (paragraph 0171). To produce high resolution laser marked data, it is preferred to use a near infrared (NIR) laser having an emission wavelength between 750 and 2500, preferably between 800 and 1500 nm in the laser marking step (see paragraph 0175).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Kameni et al. by achieving a visible effect on a softgel capsule through applying laser irradiation to the softgel capsule at a wavelength of greater than1100 nm to about 2200 nm because Momoi teaches a marking method that is highly productive and enables production of easily-identifiable compositions for use in oral administration such as drugs and foods without damaging the quality of the oral composition. The marking method according to the present invention is a method for marking such a composition for use in oral administration and includes the steps of: dispersing a change in color-inducing oxide in the composition for use in oral administration; and scanning a surface of the composition for use in oral administration with a laser beam at wavelengths of from 200 nm to 1100 nm and with from 0.1 W to 50 W average power in to make the particles of the change in color-inducing oxide agglomerate so as to become discolored. The change in color-inducing oxide used in the present invention is at least one selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide (see abstract). The examiner notes that one can pick the iron oxide from the Markush list which will avoid titanium dioxide. Regarding the laser irradiation wavelength of greater than 1100 nm to about 2200 nm, first Momoi’s teaching of 1100 nm is close enough to greater than 1100 nm, it is expected to work similarly. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In a preferred embodiment of the manufacturing method according to the present invention, there is provided a method for manufacturing a composition for use in oral administration, including the steps of: obtaining a composition for use in oral administration, which has a coating layer in which at least one type of change in color-inducing oxide selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide, is dispersed; and making an identification mark by scanning a surface of the coating layer with a laser beam at wavelengths of from 200 nm to 1100 nm and with from 0.1 W to 50 W average power. The coating layer may comprise any of titanium dioxide, yellow ferric oxide, and red ferric oxide, but there is no particular limitation on combinations of these oxides or any other components. Specific examples of the coating layer include capsule coating layers, film-coated layers, and sugar-coated layers. The dosage forms of the composition for use in oral administration in a preferred embodiment of the present invention are: film-coated tablets, sugar-coated tablets, hard capsules, and soft capsules (paragraph 0018). Momoi teaches with regard to pharmaceutical compositions for use in oral administration such as tablets and capsules, not only their packages, but also the compositions themselves are required to be identifiable in order to prevent mistakenly dispensing or taking the wrong drugs. However, there are limitations to identifying tablets and capsules with only their shapes and color tones. Therefore, marks are made on the surface of tablets and capsules in order to enhance identifiability. For example, the following methods are employed for marking tablets and capsules: transfer-type printing using a rubber roller to directly print letters and the like on a the surface of film-coated tablets and capsules; and inkjet-type printing of printing ink dots on the surface of film-coated tablets or capsules. In the case of uncoated tablets, a method for imprinting tablets, using a tableting punch with a concave-convex surface, has been employed since old times (paragraph 0002). However, these classic methods like the transfer-type printing are easily affected by, for example, the surface condition of tablets or capsules and the atmosphere where the printing is carried out. Accordingly, very complicated management is required in order to stably provide clear printing. Also, in the case of inkjet-type printing, insufficient drying of ink causes stains, or blurring of the printed letters on the tablets, which may have an influence on the appearance of the tablets. Furthermore, in the case of imprinting, tablets and capsules have spherical surfaces in many cases and, therefore, there are limitations on the area on the tablet surface where letters and the like can be printed, and the number and size of letters or the shapes of graphic symbols that can be printed on the tablet surface. Consequently, the amount of information provided by the marked tablets is not always sufficient. Also, imprinting requires an exclusive punch for each product. Moreover, depending on the shape of the engraved mark, sticking may easily occur, resulting the engraved part being chipped off; and the engraved part may also wear off in the post-tableting step as well, which will cause an increase in the defect rate in an appearance examination. The engraved part may also chip off in the distribution process, which may not only decrease identifiability, but also have an influence on the product quality (paragraph 0003). One of ordinary skill in the art would have been motivated to do so because Momoi teaches that, the laser beam based marking method is highly productive and which enables production of easily-identifiable compositions for use in oral administration such as drugs and foods without damaging the quality of the compositions for use in oral administration (see paragraph 0009). Momoi teaches that as a result of thorough research of a method for marking the compositions for use in oral administration in light of the circumstances described above, the inventor of the present invention have found that irradiation of the surface of a composition for use in oral administration, in which a specified change in color-inducing oxide is dispersed, with a specified laser beam causes change in color of the surface due to agglomeration of the change in color-inducing oxide. As a result of this agglomeration phenomenon, the present inventor has completed the present invention (see paragraph 0010). Furthermore, in the case where the claimed ranges of measurable parameters" 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). Furthermore, differences in concentration or measurable parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Kameni et al. and Momoi by utilizing fiber laser for achieving marking and by utilizing laser irradiation at wavelength of greater than 1100 nm to about 2200 nm because Goethals et al. teach a method of marking an article (1) comprising a marking step wherein the article (1) including a first (100) and a second (200) colour-forming layer provided on at least part of a support (500), each colour-forming layer capable of forming respectively a first and a second colour upon marking, is marked thereby forming an image (350, 350'), characterized in that first and the second colour are formed simultaneously in at least part of the marking step (see abstract). One of ordinary skill in the art would have been motivated to do so because Goethals et al. teach that another advantage of using laser marking or thermal printing instead of another printing technique, such as inkjet printing, is the absence of any chemicals in the marking process. Especially for pharmaceutical and food packaging, the absence of chemicals in the packaging line is an advantage (paragraph 0155). The laser can be a solid state laser, such as a disk laser, a Nd:Yag laser or a Fiber laser. The laser can be a gas laser, such as a He-Ne laser, a CO2-laser, or an Excimer laser (paragraph 0171). To produce high resolution laser marked data, it is preferred to use a near infrared (NIR) laser having an emission wavelength between 750 and 2500, preferably between 800 and 1500 nm in the laser marking step (see paragraph 0175). Momoi clearly also teaches an overlapping range of wavelengths of from 200 nm to 1100 nm. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Kameni et al., Momoi, and Goethals et al. because all of the references are drawn to encapsulated compositions.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 29 June 2026 have been fully considered but they are not persuasive.
Applicants argue Kameni is directed to softgel capsule formulations and is entirely silent regarding marking and laser irradiation. While Momoi discusses laser irradiation "at wavelengths of from 200 nm to 1100 nm" (see Momoi, Abstract), claim 1, as amended, recites a wavelength of greater than 1100 nm to about 2200 nm. This amended range is entirely outside Momoi's disclosed range, with zero overlap between the claimed wavelength range and Momoi's teaching. Momoi's preferred wavelengths of "from 1060 to 1064 nm, from 527 to 532 nm, from 351 to 355 nm, from 263 to 266 nm, or from 210 to 216 nm" (see Momoi, paragraph 0027) trend toward the UV spectrum, away from wavelengths above 1100 nm. Momoi provides no teaching, suggestion, or motivation to extend laser wavelength beyond its disclosed upper bound of 1100 nm. Because Kameni is silent as to laser marking entirely, a person of ordinary skill in the art would have no basis in Momoi for modifying Kameni's softgel capsule to use laser irradiation at wavelengths greater than 1100 nm. Claim 1, as amended, also recites that "the marking formulation does not include titanium dioxide." Kameni discloses iron oxide among other possible colorants for softgel capsule shells, but Kameni does not disclose using any colorant, including iron oxide, as a marking component responsive to laser irradiation. See Kameni. Momoi's only example near the claimed wavelength range (Example 13, using a 1064 nm laser) employed titanium dioxide as the color-inducing oxide and produced results that were "slightly inferior" to those obtained at lower wavelengths. See Momoi, paragraph 0059. Momoi's mechanism analysis is based entirely on titanium dioxide particle agglomeration (see Momoi, paragraphs 0065-0066), and the behavior of ferric oxide is merely "assumed" to follow the same agglomeration phenomenon by analogy. See Momoi, paragraph 0066. Critically, Momoi teaches that the color-change effect "cannot be obtained by any other metallic oxides" besides titanium dioxide, yellow ferric oxide, and red ferric oxide. See Momoi, paragraph 0025. Momoi never demonstrated that iron oxide alone, without titanium dioxide, could produce a visible marking effect at any wavelength, let alone at wavelengths above 1100 nm, which is outside Momoi's disclosed range entirely. Accordingly, one of ordinary skill in the art would not be motivated to modify Kameni to use iron oxide alone as a marking component without titanium dioxide for laser marking at wavelengths greater than 1100 nm. Goethals was cited as allegedly teaching other aspects of the claims, but fails to remedy the deficiencies of Kameni and Momoi discussed above. Goethals mentions NIR laser wavelengths "between 750 and 2500, preferably between 800 and 1500 nm." See Goethals, paragraph 0175. However, Goethals is directed to marking articles with leuco dyes and color-forming layers using optothermal converting agents, which is a completely different marking technology than the metal oxide agglomeration mechanism disclosed in Momoi and recited in the claims. See Goethals, paragraphs 0031-0035, 0070-0075. Goethals does not teach the use of iron oxide as a marking component; instead, Goethals discloses infrared absorbing dyes and pigments such as tungsten oxide, copper salts, and carbon black as optothermal converting agents. See Goethals, paragraphs 0080-0091. Thus, even if one were to combine Goethals' wavelength range with Kameni and Momoi, Goethals provides no teaching or motivation to use iron oxide as a marking component in a softgel capsule shell without titanium dioxide. The combination of Kameni, Momoi, and Goethals still fails to teach or suggest the specific combination of features now recited in claim 1 as amended: laser irradiation at wavelengths greater than 1100 nm applied to a softgel capsule comprising a marking formulation with a metal oxide marking component such as iron oxide, without titanium dioxide.
The above assertions are not found persuasive because first, the rejection is based on the combination teachings of the references not Kameni only. 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). Second, Kameni already supplies the softgel platform and iron oxide in the shell. Applicant concedes that Kameni discloses iron oxide among other possible colorants for softgel/softshell capsule shells. That concession is correct and is fatal to the argument that Kameni is irrelevant to a “marking component.” Kameni is directed to softshell capsule formulations comprising a fill composition encapsulated in a shell (gelatin or non-gelatin) that may contain conventional pharmaceutical colorants/pigments, including iron oxides. One of ordinary skill in the art reading Kameni would understand iron oxide as a shell-resident, pharmaceutically acceptable, already-dispersed particulate colorant. The only missing teaching in Kameni is the use of that already-present iron oxide as a laser-responsive marking species and the recited irradiation band or wavelength. Those teachings come from Momoi and Goethals. Under KSR, it is not necessary that the primary reference itself disclose every functional use of an ingredient it already places in the same matrix. Applicant’s statement that “Kameni doesn’t disclose using any colorant including iron oxide as a marking component responsive to laser irradiation” is therefore an attack on a single reference, not on the combination. That is not a proper response to a § 103 rejection.
The examiner reminds Applicant that Momoi also expressly teaches iron oxides as laser-responsive marking components in oral compositions, including soft capsules, and does not require titanium dioxide, Momoi is not limited to titanium dioxide. Momoi’s abstract, independent method, and preferred embodiments define the “change in color-inducing oxide” as at least one selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide as described in detail above. Ferric oxides are listed as coequal members of the inventive class, not as afterthoughts. Momoi’s functional definition is equally explicit: a change-in-color-inducing oxide is “an oxide whose particle[s] agglomerate and [are] thereby induced to become discolored due to laser beam irradiation.”. Titanium dioxide, yellow ferric oxide, and red ferric oxide are all identified as members of that class. The teaching is therefore not “TiO2 agglomeration, with ferric oxide merely assumed by analogy.” It is an express grouping of three oxides that Momoi found to undergo the same laser-induced agglomeration/discoloration phenomenon in oral dosage forms. Furthermore Momoi also: expressly includes soft capsules among preferred dosage forms as described above; Example 3--gelatin soft capsules marked with letters using the disclosed laser conditions); teaches dispersing the oxide in a coating layer / shell (capsule coating layers are listed); teaches that combinations of the oxides are not limited; and therefore permits a composition in which the only change-in-color-inducing oxide is yellow and/or red ferric oxide — i.e., a formulation that does not include titanium dioxide.
Applicant’s argument that “Momoi’s mechanism analysis is based entirely on titanium dioxide particle agglomeration and the behavior of ferric oxide is merely assumed to follow the same agglomeration phenomenon by analogy” mischaracterizes the reference. Momoi places ferric oxides inside the claimed group and inside the same functional definition. One of ordinary skill in the art is not required to re-prove a mechanism that the prior art already attributes to the same oxides. Even if some of Momoi’s mechanistic discussion is illustrated with TiO2, the claims and working description treat ferric oxides as operative marking components. That is sufficient under § 103. Regarding the laser irradiation wavelength, Momoi teaches laser wavelengths of 200 nm to 1100 nm, with a preferred window of 1060–1064 nm (Nd:YAG / YVO4 fundamental) in addition to visible and UV harmonics. The claimed range begins at “greater than 1100 nm.” That is a difference of a few nanometers at the boundary of a commercially standard NIR marking laser (1064 nm fiber/Nd:YAG). Overlapping or immediately adjacent ranges, especially where the same oxides and the same dosage-form matrix are already shown to mark, do not confer patentability. See In re Peterson; In re Wertheim. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, Goethals supplies the motivation to move further into the IR. Momoi’s Example 3 (soft capsules containing TiO2 in the gelatin coat, marked to a visible gray) further confirms that the method is practiced on the same article type as the claim. Substituting or omitting TiO2 in favor of the ferric oxides Momoi itself lists is an express alternative, not an unpredictable leap. Furthermore, Goethals supplies IR/optothermal marking at wavelengths in and beyond the claimed band and the motivation to use IR-absorbing pigments without TiO2. Goethals is directed to laser marking of articles, including heat-sensitive articles and packaging, using an infrared laser and an optothermal converting agent (IR-absorbing dye or pigment) so that absorbed IR energy produces a visible mark (color formation / thermal response). Preferred lasers are infrared lasers. Exemplary IR absorbers include tungsten oxide, cesium tungsten oxide, copper salts, carbon black, and IR dyes (e.g., IR1064). Applicant is correct that Goethals’ working examples emphasize tungsten oxide, copper salts, carbon black, and organic IR dyes rather than iron oxide per se. That does not defeat the combination, for three reasons: Goethals is not cited as the source of iron oxide. Iron oxide is already in Kameni’s shell and is already a laser-responsive marking oxide in Momoi. Goethals is cited for (a) IR laser marking of articles with an IR-absorbing pigment dispersed in a matrix, (b) the optothermal-conversion principle, and (c) wavelengths and laser types (IR / ~1064 nm and longer IR) that sit at and above Momoi’s upper bound and inside the claimed “greater than 1100 nm to about 2200 nm” window (fiber, diode, and other NIR/SWIR sources); iron oxides are known NIR absorbers. One of ordinary skill in the art combining Momoi’s ferric-oxide marking particles with Goethals’ teaching to mark with IR lasers and IR-absorbing pigments would reasonably expect iron oxide already shown by Momoi to discolor under 1060–1064 nm irradiation to function as an optothermal/marking pigment at neighboring and slightly longer NIR wavelengths. No new principle of operation is required.
Regarding the motivation to use IR rather than UV/visible, and to omit TiO2, Goethals teaches IR marking specifically for heat-sensitive articles and for late-stage variable-data marking. Softgel shells are heat- and moisture-sensitive gelatin (or polymer) films. One of ordinary skill in the art would be motivated to do: use a longer-wavelength IR source (less surface ablation/etching of the gelatin film than UV or high-energy visible; Momoi itself warns that excessive energy etches the surface); rely on an IR-absorbing metal oxide already present as a colorant (Kameni + Momoi) rather than adding a separate IR dye or carbon black that may raise color, purity, or regulatory issues in an oral softgel; and omit titanium dioxide where opacity, regulatory status (e.g., food-contact / “TiO2-free” labeling), or color shade so require an option Momoi already provides by listing ferric oxides as standalone members of the marking-oxide group.
Regarding Applicant’s assertion that “Goethals provide[s] no teaching or motivation to use iron oxide as a marking component in a softgel capsule shell without titanium dioxide” again attacks Goethals in isolation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The motivation is the combination wherein the Kameni’s iron-oxide-containing softgel shell + Momoi’s teaching that those same oxides are laser-markable color-change agents + Goethals’ teaching to mark articles with IR lasers and IR-absorbing pigments. That is a classic combination of known elements (softgel shell, iron oxide colorant, laser-induced visible change, IR source) performing their known functions to yield the predictable result of a visible laser mark on a TiO2-free iron-oxide-tinted softgel. The combination remains proper. One of ordinary skill in the art seeking to identify softgel capsules would take Kameni’s iron-oxide-colored softgel shell, apply Momoi’s teaching that yellow/red ferric oxide particles dispersed in a capsule shell produce a visible mark on laser irradiation, omit TiO2 because Momoi already permits that alternative, and select an IR source in the >1100–2200 nm band as taught by Goethals for marking heat-sensitive articles with IR-absorbing pigments. The result is the claimed capsule.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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