DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed March 12, 2026, has been received and entered.
Claims 5, 6, 13, 14, 17, 21, 24, 25, 27, 28, and 31-45 are canceled. Claim 46 is new.
Claims 1-4, 7-12, 15, 16, 18-20, 22, 23, 26, 29, 30, and 46 are pending.
Claims 15, 16, 18-20, 22, 23, 26, and 29 are withdrawn.
Claims 1-4, 7-12, 30, and 46 are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7-12, and 46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following limitation in claim 1 is not supported by the specification as filed: “wherein the tissue staining composition does not contain a metallic pigment.” Applicant’s arguments filed March 12, 2026, are unpersuasive with respect to this negative limitation being supported by the specification. Applicant cites paragraphs [0037] and [0045]-[0052] of the published application. Paragraph [0045] of the published application, corresponding to paragraph [0042] of the originally filed application, discloses that the colorant “may include one or more of an organic pigment such as…” Organic pigments are thus set forth as one example of pigments in the specification, thereby not limiting the pigments to organic pigments. Merely describing “organic pigments” is insufficient for supporting the negative limitation, since metallic pigments are not the only other option to exist other than organic pigments. In particular, Parsons (Surface Coatings. Springer, Dordrecht, 1993. Chapter 27) indicates that pigments can classified as either inorganic pigments or organic pigments, wherein inorganic pigments include extender pigments, titanium dioxide, coloured inorganics, metallic pigments, effect pigments, and functional pigments (Section 27.3 and Figure 27.2 on page 452). The skilled artisan would not have understood the description of organic pigments in the specification as indicative of the exclusion of metallic pigments since metallic pigments are not the only alternative to organic pigments for the genus of pigments.
While Applicant was in possession of a portion of the claimed invention, the full scope of the claimed invention, specifically the limitation that the tissue staining composition does not contain a metallic pigment, is not fully described in the specification. As such, Applicant was not in possession of the full scope of the claimed invention at the time of filing. Because the specification as filed fails to provide clear support for the new claim language, a new matter rejection is clearly proper.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Prolss (US 2012/0274714. Previously cited) in view of Nsib (Progress in Organic Coatings. 2006. 55: 303-310. Previously cited).
Prolss discloses an ink jet printing ink comprising aluminium effect pigments mixed with components of ink jet printing inks such as solvents, diluents, and/or binding agents (paragraph [0019]). In a preferred embodiment, the aluminium effect pigments have a d50-value in a range of about 1 µm to 12 µm, most preferably of about 2 µm to below 6 µm (paragraph [0032]). Since the aluminium effect pigments are directed to pigment particles having a D50 particle size in a range of about 1 microns to 12 microns (overlapping the claimed pigment particle size range) and most preferably of about 2 microns to below 6 microns (falling within the claimed pigment particle size range), then Prolss teaches the pigment particles of instant claim 30.
The solvent of Prolss is directed to a ‘liquid carrier.’ See paragraph [0097] teaching preferred solvents as including water and alcohols. Claim 14 of Prolss teaches the ink jet printing ink further comprising at least one of at least one solvent and at least one diluent. Therefore, Prolss suggests an ink jet printing ink further comprising a solvent and a diluent. The combination of the aluminium effect pigments and the solvent is directed to a colorant comprising pigment particles and a liquid carrier (the solvent).
Prolss meets limitations of the claimed invention since Prolss renders obvious a composition comprising a colorant comprising pigment particles having a D50 particle size that falls within the claimed range of ‘about 5 microns or less’ and a liquid carrier (a solvent); and a diluent. The limitation of instant claim 30 of a ‘staining composition’ is directed to an intended use and functional characteristic of the composition of instant claim 30. According to MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” Moreover, MPEP 2112(I) also states, “Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” Since the composition of Prolss comprises pigments, then the composition of Prolss would have necessarily been suitable for the claimed intended use of staining.
Prolss differs from the claimed invention in that Prolss does not expressly disclose that their ink jet printing ink has a viscosity of about 10 Krebs Units or less.
However, Prolss discloses that in one embodiment, the ink jet printing ink has a viscosity in a range from about 1 to 100 cps, preferably in a range of about 3 cps to 30 cps, and more preferably in a range of 5 to 20 cps (paragraphs [0106]-[0107]). Moreover, the viscosity can be adjusted to accommodate the type of print head used, the substrate to be printed on, and/or the composition of the ink jet printing ink (paragraph [0108]).
Nsib discloses that viscosity expressed in Krebs units (KU) has been converted into mPa s units with tables provided by the supplier of viscometers (page 304, right column, first full paragraph). It is well known in the art that units of mPa·s are equivalent to centipoise (cp; cps for centipoises). Table 3 of Nsib shows that the viscosity of 84 KU converted to 930 mPa s (i.e., 930 cps) and the viscosity of 93 KU converted to 1307 mPa s (i.e., 1307 cps).
Based on the conversion of Krebs units to mPa s taught in Nsib in which 930 cps converts to 84 Krebs units, then it is obvious that the range of about 1 to 100 cps of Prolss converts to viscosity in Krebs units much lower than 84 Krebs units, specifically viscosities falling in the claimed range of ‘about 10 Krebs Units or less.’ Moreover, it would have been a matter of routine optimization to have adjusted the viscosity of the ink jet printing ink of Prolss to low viscosities, including viscosities falling in the claimed range of about 10 Krebs Units or less, because Prolss teaches adjusting the viscosity to accommodate various factors (paragraph [0108]).
Additionally, Prolss teaches that preferably the ink jet printer has a container reserved for aluminium effect pigments containing ink jet printing ink (paragraph [0121]). The container suggests a bottle. Thus, Prolss in view of Nsib renders obvious a kit comprising a bottle containing a staining composition (ink jet printing ink) disposed therein, wherein the staining composition comprises: a diluent, and a colorant comprising pigment particles having a D50 particle size falling within the claimed range of ‘about 5 microns or less’ and a liquid carrier (a solvent).
Further still, the discussion in the Prolss publication of the use of the ink jet printing ink (e.g., paragraph [0126]) is directed to instructions for using the staining composition (ink jet printing ink). Moreover, the instructions of instant claim 30 are printed matter that do not have a functional relationship with the reagents. According to MPEP 2112.01(III), “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").” Thus, the instructions of instant claim 30 do not patentably distinguish the claimed kit from the invention rendered obvious by Prolss in view of Nsib. As such, instant claim 30 is rendered obvious.
Claims 1, 2, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Morton (US 6,815,170) in view of Hasan (Journal of Neuroscience Methods. 2012. 204: 249-253) and Nsib (Progress in Organic Coatings. 2006. 55: 303-310. Previously cited).
Morton discloses a fluid composition that is used in a method for identifying a disease-associated lymph node in an excised tissue sample, wherein the fluid composition comprises of from about 0.1% to about 6.0% carbon particles (column 3, lines 1-5). In certain embodiments, the carbon particles comprise carbon black (column 3, lines 65-66). According to the instant specification, carbon black is an organic pigment (paragraph [0042]). Since carbon black is set forth in the specification as an organic pigment, then it meets the claimed limitation. Carbon particles in carbon dye are heterogenous and range from about 0.1 to about 6.0 microns in diameter (column 19, lines 20-21). Preferred diameters of carbon black particles include from about 2.0 to about 5.0 microns, or about 0.2 to about 4.0 microns, or about 2.0 to about 3.0 microns, or about 0.2 to about 2.0 microns, or about 0.2 to about 1.0 microns, or about 0.3 to about 1.0 microns, or about 0.3 to about 0.8 microns, or about 0.4 to about 0.7 microns (column 19, lines 25-31). Given these preferred diameter ranges for carbon black particles which have a maximum limit of about 5.0 microns, it follows that the D50 particle size of the carbon black particles, directed to the claimed ‘organic pigment,’ necessarily falls within the claimed range of ‘about 5 microns or less.’
Furthermore, Morton discloses that aqueous compositions of their invention comprise an effective amount of the carbon black suspension, further dispersed in a pharmaceutically acceptable carrier or aqueous medium (column 26, lines 4-7). The term “pharmaceutically acceptable carrier” as used in Morton includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like (column 26, lines 11-13). Also, solutions of compositions can be prepared in water suitably mixed with a surfactant, and dispersions also can be prepared in glycerol, liquid polyethylene glycols, mixtures thereof and in oils (column 26, lines 19-22). Morton discloses an example of a commercially available carbon dye containing water (about 85%), carbon black (about 6%), and a suspending vehicle (column 19, lines 33-35). Water is directed to the claimed ‘diluent’ (see paragraphs [0009] and [0052] of the instant specification, recognizing water as a diluent), and a suspending vehicle is directed to the claimed ‘liquid carrier.’ For the invention of Morton in which the carbon black particles have the preferred diameters (column 19, lines 25-31), it would have been prima facie obvious to apply their teachings regarding the pharmaceutically acceptable carrier, and in particular the combination of water and a suspending vehicle, as they were recognized in Morton for the practice of their invention. Therefore, Morton renders obvious a composition (their fluid composition) comprising a colorant comprising organic pigment particles (carbon black particles) having a D50 particle size of about 5 microns or less and a liquid carrier; and a diluent.
Morton does not disclose instances in which their fluid composition comprises a metallic pigment, and Morton teaches at least one example that does not include a metallic pigment (e.g., column 19, lines 33-35).
Furthermore, Morton teaches that their invention demonstrates the surprising ability of relatively dilute concentrations of carbon particles to specifically identify sentinel lymph nodes in histopathological studies (column 9, lines 53-56). Furthermore, full-strength carbon dye stains all sentinel lymph nodes (column 9, lines 60-61). Therefore, the fluid composition of Morton is directed to a ‘tissue staining composition.’
In sum, Morton meets limitations of the claimed invention by rendering obvious a tissue staining composition comprising: a colorant comprising organic pigment particles (carbon black particles) having a D50 particle size of about 5 microns or less and a liquid carrier; and a diluent, wherein the tissue staining composition does not contain a metallic pigment.
Morton differs from the claimed invention in that Morton does not expressly disclose that their fluid composition has a viscosity of about 10 Krebs Units or less.
Hasan discloses visualizing rodent cerebral vasculature (abstract). Hasan points out that rodent studies provide significant insight into cerebral vascular morphology and its dynamic adaptation to environmental stimuli (page 249, left column, first paragraph). A common limitation of previous techniques using latex for visualizing cerebral vasculature in small animals is inefficient perfusion due to high viscosity of latex/gelatin compound resulting in a lack of reproducibility (page 249, right column, first paragraph). Therefore, Hasan developed a simple and reproducible technique using two commercially available carbon black inks without any latex compound to visualize the cerebral vasculature (page 249, right column, first paragraph). The two carbon black inks used in the study are CB1 of 2.1% carbon black with a very low viscosity of 1.1 mPa/s, and CB2 of 2.5% carbon black have a greater viscosity of 10-50 mPa/s (page 252, left column). In particular, a 1:9 ratio of CB1:CB2 was used for permanent staining of vessels (page 252, right column). Hasan found that due to its relatively less viscosity, CB1+CB2 perfusion yielded better filling of the vessels at a higher density per square millimeter of brain area in comparison to latex of various dilutions (page 253, left column, first full paragraph).
Nsib discloses that viscosity expressed in Krebs units (KU) has been converted into mPa s units with tables provided by the supplier of viscometers (page 304, right column, first full paragraph). Table 3 of Nsib shows that the viscosity of 84 KU converted to 930 mPa s and the viscosity of 93 KU converted to 1307 mPa s.
Based on the conversion of Krebs units to mPa s taught in Nsib, then it is obvious that the CB1 and CB2 viscosities of Hasan of 1.1 mPa/s and 10-50 mPa/s convert to viscosities in Krebs units much lower than 84 Krebs units, specifically viscosities falling in the claimed range of ‘about 10 Krebs Units or less.’
Before the effective filing date of the claimed invention, it would have been a matter of routine optimization to select for a low viscosity, specifically a viscosity in the range of about 10 Krebs Units or less, for the fluid composition rendered obvious by Morton for the predictable result of perfusing a tumor with the fluid composition in order to identify lymph nodes in a patient as sought by Morton (column 25, lines 1-10). The skilled artisan would have recognized that the viscosity of the fluid composition of Morton is a results-effective parameter for optimization to achieve suitable perfusion of a tumor in a patient since Hasan teaches that viscosity affects perfusion of tissue, thus being a critical parameter affecting perfusion of tissue. There would have been a reasonable expectation of obtaining a fluid composition of Morton having a viscosity in the range of about 10 Krebs Units or less because Hasan teaches carbon black inks having such low viscosities in view of Nsib.
Therefore, Morton in view of Hasan and Nsib renders obvious instant claim 1.
Regarding instant claim 2, Morton discloses a preferred concentration of carbon black ranging from about 0.1% to about 6.0% (column 19, lines 36-37). In one example, a commercially available carbon dye contains about 85% water, about 6% carbon black, and a suspending vehicle (column 19, lines 33-35). Therefore, the suspending vehicle is about 9% of the composition (100% - 85% - 6% = 9%), wherein the suspending vehicle is directed to the claimed ‘liquid carrier’ and the water is directed to the claimed ‘diluent.’ Therefore, that carbon dye is directed to a composition comprising a colorant comprising about 6% carbon black particles (directed to the claimed ‘organic pigment particles’) and about 9% liquid carrier (the suspending vehicle), signifying that the colorant is in an amount of about 15% by weight of the composition (about 6% + about 9%) which falls in the claimed range. Therefore, instant claim 2 is rendered obvious.
Regarding instant claim 7, as discussed in the preceding paragraph, Morton teaches an example of a commercially available carbon dye containing about 85% water (column 19, lines 36-37), wherein water is directed to a ‘diluent.’ Though the diluent is present in an amount that is above the claimed range of about 40% to about 75% by weight of the composition, it would have been a matter of routine optimization to have reduced the amount of the water in the fluid composition rendered obvious by Morton in view of Hasan and Nsib to an amount falling in the claimed range because Morton teaches that the exact concentration of the various components, e.g., aqueous carriers including water, are adjusted according to well known parameters (column 26, lines 40-47). Therefore, instant claim 7 is rendered obvious.
Regarding instant claims 8 and 9, Morton discloses that in some preferred embodiments, the composition further comprises at least one additional compound, wherein in specific aspects, the at least one additional compound is a dye (column 4, lines 3-5). Therefore, instant claim 8 is rendered obvious. Further still, the total concentration of dye in the composition may be about 0.10%, about 0.15%, about 0.20%,…about 9.90%, to about 10.00%, and any range derivable therein (column 4, lines 26-56). These concentrations fall within the claimed range. Thus, instant claim 9 is rendered obvious.
Regarding instant claim 10, Morton teaches that the kind of carbon black is not particularly restricted, and acidic carbon black, neutral carbon black, and alkaline carbon black can be used (column 16, lines 60-63). See also column 3, line 66 through column 4, line 2. As pointed out above, Morton teaches an example of a commercially available carbon dye containing about 85% water, about 6% carbon black, and a suspending vehicle (column 19, lines 33-35). Given that the carbon black particles can be alkaline and the composition can contain about 85% water, it would have been obvious that the fluid composition rendered obvious by Morton in view of Hasan and Nsib is alkaline (when the carbon black particles are alkaline) as the carbon black particles would have increased the pH from the neutral pH of 7.0 of the predominant component of the fluid composition (water) to a pH falling in the claimed range of about 7.75 to about 9.0. Moreover, Morton teaches that the pH of the various components are adjusted according to well known parameters (column 26, lines 45-47), which would have suggested the routine optimization of the pH of the composition, including to the claimed range. Therefore, instant claim 10 is rendered obvious.
Regarding instant claim 11, Morton discloses that their composition further comprises a pharmaceutically acceptable carrier that includes any and all solvents (column 26, lines 4-12), the solutions of compositions can be prepared in water suitably mixed with a surfactant (column 26, lines 19-20). Also, under ordinary conditions of storage and use, the preparation contains a preservative to prevent the growth of microorganisms (column 26, lines 22-25). Therefore, it is obvious that the fluid composition rendered obvious by Morton in view of Hasan and Nsib comprises a solvent, a preservative, and/or a surfactant, rendering obvious instant claim 11.
Claims 3, 4, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Morton, Hasan, and Nsib as applied to claims 1, 2, and 7-11 above, and further in view of Phillips (US 2017/0189135. Listed on IDS filed 3/23/26).
As discussed above, Morton in view of Hasan and Nsib renders obvious claims 1, 2, and 7-11. The references differ from claim 3 in that they do not expressly disclose that the fluid composition further comprises a binder. The references further differ from claim 4 in that they do not expressly disclose that the binder comprises an acrylic resin. The references further differ from claim 46 in that they do not expressly disclose that the acrylic resin is an alkali soluble styrene.
Phillips discloses an ink composition for marking a tissue specimen (abstract). The ink composition comprises a pigment, deionized water, and alkali soluble styrene, amongst other components (abstract). Phillips points out that their invention is well suited for use with any excised tissue that requires for pathology analysis designation of the specimen’s, and these tissues include specimens of lymph nodes (paragraph [0033]). Phillips found that in their ink composition, alkali soluble styrene acrylic resin is one of the keys to superior adherence to tissue and fast drying on tissue (paragraph [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to include alkali soluble styrene resin in the fluid composition rendered obvious by Morton in view of Hasan and Nsib. One of ordinary skill in the art would have been motivated to do this because an alkali soluble styrene resin is found as a suitable component for marking tissue (according to Phillips) and would have been expected to improve the adherence of the carbon black particles to lymph nodes, which would have been sought by Morton as it teaches using their fluid composition to identify lymph nodes (abstract and column 25, lines 1-10). There would have been a reasonable expectation of using the fluid composition comprising an alkali soluble styrene resin for Morton’s method of identification of lymph nodes because Phillip indicates that it is a suitable component of a pigment-containing composition for marking a tissue specimen, including specimens of lymph nodes. Alkali soluble styrene resin is directed to a binder, specifically an acrylic resin of instant claim 4 and the specific acrylic resin of instant claim 46. Therefore, instant claims 3, 4, and 46 are rendered obvious.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Morton, Hasan, and Nsib as applied to claims 1, 2, and 7-11 above, and further in view of Lindstrom (The Seybold Report. 2008. 8(3): 13-14. Previously cited).
As discussed above, Morton in view of Hasan and Nsib renders obvious claims 1, 2, and 7-11. The references differ from claim 12 in that they do not expressly disclose that the fluid composition is a first staining composition, wherein, when stained on tissue and compared to tissue stained with a second staining composition of a different color, the first staining composition has a Delta E of at least about 20 in reflected and/or transmitted light.
Lindstrom discusses Delta E in the context of printing. Lindstrom teaches that traditionally, a Delta E value of 1 or lower is considered not to be detectable by human vision, while Delta E values of 2-4 are just noticeable (page 13, right column, third paragraph). At around Delta E of 10 and above, people recognize that two colors are not the same because they do not match at all (page 13, right column, third paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art that the fluid composition rendered obvious by Morton in view of Hasan and Nsib (directed to a first staining composition) would have had a Delta E of at least about 20 in reflected and/or transmitted light if used to stain a tissue and compared to tissue stained with a second staining composition of a different color. This would have been obvious since the claimed ‘second staining composition’ is broadly drawn to any staining composition and the ‘different color’ of the second staining composition can be any color, including a color that is readily distinguished by a person when compared with the color if tissue is stained with the fluid composition rendered obvious by Morton in view of Hasan and Nsib that is a black ink that is more easily distinguished from other colors. Since people distinguish two colors when the Delta E is 10 and above, as indicated in Lindstrom, then it is obvious that the Delta E for the fluid composition rendered obvious by Morton, Hasan, and Nsib is above 10 when stained on tissue and compared to tissue stained with a second staining composition of a different color. Therefore, instant claim 12 is rendered obvious.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Morton (US 6,815,170).
Morton discloses a fluid composition that is used in a method for identifying a disease-associated lymph node in an excised tissue sample, wherein the fluid composition comprises of from about 0.1% to about 6.0% carbon particles (column 3, lines 1-5). In certain embodiments, the carbon particles comprise carbon black (column 3, lines 65-66). According to the instant specification, carbon black is an organic pigment (paragraph [0042]). Thus carbon black particles are directed to ‘pigment particles’ as claimed. Carbon particles in carbon dye are heterogenous and range from about 0.1 to about 6.0 microns in diameter (column 19, lines 20-21). Preferred diameters of carbon black particles include from about 2.0 to about 5.0 microns, or about 0.2 to about 4.0 microns, or about 2.0 to about 3.0 microns, or about 0.2 to about 2.0 microns, or about 0.2 to about 1.0 microns, or about 0.3 to about 1.0 microns, or about 0.3 to about 0.8 microns, or about 0.4 to about 0.7 microns (column 19, lines 25-31). Given these preferred diameter ranges for carbon black particles which have a maximum limit of about 5.0 microns, it follows that the D50 particle size of the carbon black particles, directed to the claimed ‘pigment particles,’ necessarily falls within the claimed range of ‘about 5 microns or less.’
Furthermore, Morton discloses that aqueous compositions of their invention comprise an effective amount of the carbon black suspension, further dispersed in a pharmaceutically acceptable carrier or aqueous medium (column 26, lines 4-7). The term “pharmaceutically acceptable carrier” as used in Morton includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like (column 26, lines 11-13). Also, solutions of compositions can be prepared in water suitably mixed with a surfactant, and dispersions also can be prepared in glycerol, liquid polyethylene glycols, mixtures thereof and in oils (column 26, lines 19-22). Morton discloses an example of a commercially available carbon dye containing water (about 85%), carbon black (about 6%), and a suspending vehicle (column 19, lines 33-35). Water is directed to the claimed ‘diluent’ (see paragraphs [0009] and [0052] of the instant specification, recognizing water as a diluent), and a suspending vehicle is directed to the claimed ‘liquid carrier.’ For the invention of Morton in which the carbon black particles have the preferred diameters (column 19, lines 25-31), it would have been prima facie obvious to apply their teachings regarding the pharmaceutically acceptable carrier, and in particular the combination of water and a suspending vehicle, as they were recognized in Morton for the practice of their invention. Therefore, Morton renders obvious a composition (their fluid composition) comprising: a diluent, and a colorant comprising pigment particles (carbon black particles) having a D50 particle size of about 5 microns or less and a liquid carrier.
Furthermore, Morton teaches that their invention demonstrates the surprising ability of relatively dilute concentrations of carbon particles to specifically identify sentinel lymph nodes in histopathological studies (column 9, lines 53-56). Furthermore, full-strength carbon dye stains all sentinel lymph nodes (column 9, lines 60-61). Therefore, the fluid composition of Morton is directed to a ‘staining composition.’
Though Morton does not expressly disclose a bottle containing their fluid composition (rendering obvious the claimed staining composition), it would have been prima facie obvious to the person of ordinary skill in the art to have provided the fluid composition in a bottle in order to hold and retain the fluid composition for its subsequent use.
Further still, the discussion in the Morton publication of the use of the fluid composition (e.g., column 3, lines 1-10) is directed to instructions for using the staining composition. Moreover, the instructions of instant claim 30 are printed matter that do not have a functional relationship with the reagents. According to MPEP 2112.01(III), “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").” Thus, the instructions of instant claim 30 do not patentably distinguish the claimed kit from the invention rendered obvious by Morton.
Since Morton renders obvious the components of the claimed kit, then Morton renders obvious instant claim 30.
Response to Arguments
Applicant’s arguments, filed March 12, 2026, with respect to the objection to claim 9, the rejections under 35 U.S.C. 112(b) of claims 4, 12, and 30, the rejection under 35 U.S.C. 103 of claims 1-4, 7-9, and 11 as being unpatentable over Prolss in view of Nsib (in light of Caliman, cited as evidence), the rejection under 35 U.S.C. 103 of claim 10 as being unpatentable over Prolss, Nsib, Caliman and further in view of Kusukame, and the rejection under 35 U.S.C. 103 of claim 12 as being unpatentable over Prolss, Nsib, and Caliman in further view of Lindstrom, have been fully considered and are persuasive. In particular, the objection has been overcome by the amendment to claim 9. The rejections under 35 U.S.C. 112(b) have been overcome by the amendments to claims 4, 12, and 30. The rejections under 35 U.S.C. 103 over claim 1 and its dependent claims have been overcome by the amendment to claim 1 because Prolss discloses aluminium effect pigments which are directed to pigment particles, but are not organic pigments particles (as amended) and instead are directed to a metallic pigment which fails to meet the amendment of ‘wherein the tissue staining composition does not contain a metallic pigment.’ Therefore, these objections and rejections have been withdrawn.
However, Applicant’s arguments are unpersuasive with respect to the rejection under 35 U.S.C. 103 of claim 30 as being unpatentable over Prolss in view of Nsib because claim 30 had not been amended. Applicant’s arguments are directed to Prolss and Nsib failing to meet the new limitations added to claim 1.
Additionally, upon further consideration, a new ground(s) of rejection is made in view of the amendment to claim 1 and the newly cited references Morton and Hasan.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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