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 .
The amendment filed 02 September 2025 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. Claims 21-22, 24-27, 46-47, and 64-75 have been canceled.
2. No new Claims have been added.
3. Claims 1, 11, 17, 76 and 78 have been amended.
4. Remarks drawn to rejections under 35 USC 103.
Claims 1-20, 23, 28-45, 48-63, and 76-78 are pending in the case. Claims 28-45, and 48-63 have been withdrawn from consideration as being drawn to a non-elected invention. Claims 1-20, 23 and 76-78 are under prosecution in this Action.
Pending claims 1, 11, 17, 76 and 78 have been amended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-20, 23, and 76-78 are rejected under 35 U.S.C. 103 as being unpatentable over Raoul et al (International Journal of Medicine and Medical Sciences, 2009, 1(5), 238-240; cited in IDS filed 06/23/2020; of record) in view of Polaske et al (WO 2016/170008 A1; cited in IDS filed 06/23/2020; of record) and further in view of Akiko et al (JP 2017099328 A; published 08/06/2017; Machine English Translation pages 1-6; cited in IDS filed 10/13/2023; of record).
Raoul et al teaches acid fast staining composition comprising basic fuchsin, alcohol, anionic surfactant, magnesium salt and preservative (page 239, left col., 1st line through right col, lines 1-5; components of claims 1, 15 and 17; magnesium salt and preservative are additives as in claim 15). Raoul teaches a composition that has 1g fuchsin in 10ml alcohol, 100ml water and 1ml Morning fresh (page 239, left col. 1st line through right col, lines 1-5). This equates to 0.90% w/v of fuchsin (as in claim 1 and claim 17, part (a)). Raoul’s composition is free of phenol. According to Raoul, due to the hazardous exposure of phenol with inherent danger to staff of histopathology that have to handle the concentrated solution, an alternative agent “Morning fresh” to ascertain faster and safer suitability is used (page 239, left col., first full para, lines 9-15). Even though Raoul teaches that phenol’s function is to increase lipophilia and acid passage of the dye through protective lipid wall, one of ordinary skill in the art will not include phenol as a component since Raoul teaches that its modified composition without phenol, stained bacilli with a similar intensity of color, and the background staining was clearer with its new staining solution than with the regular stain (page 239, right col., see under sub-title: Result and Discussion). This means that the modified composition of Raoul, which does not have phenol, is lipophilic enough for the passage of the dye through the protective lipid wall. Raoul teaches that its composition keeps well and can be used repeatedly (page 239, right col, lines 6-7). In view of this teaching, the artisan would have a reasonable expectation that the composition comprising the components recited in claim 1 will be stable for at least 420 days as in claim 14.
Raoul does not teach base as a component, and the percentage range of the surfactant as in claim 1, and the limitations of claims 2-13, 16-20, 23, and 76-78.
Polaske et al teaches a primary stain composition comprising a dye and a surfactant, wherein the dye can be fuchsin and the surfactant can be a non-ionic surfactant (para 0012, 0013; 00126; fuchsin and surfactant as in claims 1, 7 and 17). The surfactant can be present to about 0.5% (para 0016, lines 29-30; as in claim 11 and claim 17(c)). The primary stain composition can also contain Tris (para 00130-limitation of claim 6). The composition can be used on a biological sample including bacteria (para 0056). The staining composition can include non-ionic surfactants like ethers of fatty alcohols (para 00120, lines 14-18, a surfactant as in claim 1 and as in claims 7-9 and 18). According to Polaske the surfactant, when combined with the other reagent components, (i) allows for the desired surface tension to be achieved, (ii) does not denature proteins or other reagent components and/or (iii) provides low foam height (para 00111). In view of this teaching of Polaske, one of ordinary skill in the art can adjust the amount of the surfactant in terms of w/v% as in claims 1, 11, 17, 76 and 78 to get the desired surface tension and foam height.
Akiko et al teaches a composition comprising fuchsin, an alcohol and a base (Abstract; page 1, Claims, line 1; part of the limitations of claim 1 regarding the components fuchsin, base and alcohol and part of the limitations of claim 17 regarding fuchsin and base and limitation of claim 76 regarding fuchsin and an alcohol). The base used can be sodium hydroxide or tris(hydroxymethyl)aminomethane (page 2, para 13, lines 1 and 3; part of the limitation of claim 2, limitations of claims 3-6, 16 and 19 and a weak base as in claim 76). According to Akiko adding a base improves dyeability (page 3, para 6, lines 1-2). In view of this teaching one of ordinary skill in the art will include the bases as taught by Akiko in the composition of Raoul and Polaske as a component as in claims 1, 3-6, 19, and can adjust the amount of the base as in claim 2 and claim 17, part (b), and claims 20 and 77 to optimize the dyeability. Akiko teaches adjusting the pH in the range of 4.5-7. This improved the staining property of the solution (page 2, third para). Therefore, the artisan would make the composition as in claim13 and adjust its pH to be in the claimed range. Akiko suggests new fuchsin as a component (page 2, about middle of page, part (A), as in claim 12). Akiko’s composition is also free from phenol as in claims 1, 17 and 76. Even though Akiko teaches a composition comprising fuchsin and alcohol as a post-dyeing reagent, it can be seen from the teachings of Raoul and Polaske that a composition comprising fuchsin, surfactant and alcohol can be used as an acid-fast staining composition. Akiko also teaches inclusion of a base as a component and provides motivation for its inclusion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to arrive at the claimed composition since compositions comprising the recited ingredients are known to be used in staining as taught individually by the prior art. One of ordinary skill in the art would adjust the percentages of the ingredients in terms of w/v% as in claims 1-2, 11, 17, 20 and 76-78 using the amounts taught by the prior art in terms of w/w% as starting points using the appropriate conversion factors for the purpose of optimization. The artisan would look for a C8-C18 alcohol ethoxylate that comprises less than 12 moles of ethylene oxide as in claim 10, in order to obtain a composition which has optimal surfactant property. The artisan would also substitute new fuchsin as in claim 12 in the composition of Akiko and Raoul and would have a reasonable expectation of good staining, and would also make a container comprising the composition as in claim 23 so that it is ready for use when needed.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, compositions comprising the claimed ingredients are known in the art for staining. Therefore, it is obvious to combine the prior art teachings and arrive at the claimed composition.
Thus, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
Product improvement is the motivation. One of ordinary skill in the art would be motivated to make the claimed composition in order to look for acid fast staining compositions that are safer to handle and have faster and better staining ability.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 1-20 and 76-78 as it applies now under 35 USC 103 of record arguing that:
Polaske’s teachings of the amounts of surfactant present in its composition are recited in percentages by total weight of the composition, i.e., w/w% (para 0012). On the other hand, the claims of the present invention recite the amount of surfactant present in the compositions by percent of total volume (i.e., w/v%). Missing form the rejection is any clear articulation of how the disclosed surfactant ranges of Polaske would render obvious the ranges recited in the pending claims given that the two sets of ranges have different units and cannot be directly compared. The Patent Office has failed to present a prima facie case of obviousness at least over claims 11 and 78 as previously presented, and now by the way of amendment, claims 1 and 76.
None of the references disclose or suggest a staining composition including fuchsin and a surfactant, where the surfactant is present in an amount ranging from between about 1w/v% to about 3w/v% as in amended claims 1, 17 and 76.
A volume percentage may be converted to a weight percentage using the formula w/w% = (w/v%) ÷ density (g/mL). Applicant presents Table1 of the w/v% and the corresponding w/w% of the surfactant, Tergitol 15-S-9 in varying amounts, such as from 1% to 3% by total volume (page 11 in Remarks). Based on the above Table the claimed invention would utilize a w/w% of surfactant ranging from about 0.994w/w% to about 2.982w/w%. The claimed invention has a minimum of 0.994w/w% minimum whereas Polaske’s formulation has a maximum of 0.5w/w%, and its antibody formulation maximum is 0.5w/w%. Polaske provides no disclosure or suggestion that the amount of surfactant may be increased above 0.5w/w%, or the amount greater than 0.5w/w% would provide any benefits to stabilizing the composition or increasing the efficacy of staining. The combination of references would not teach all of the elements of the claimed invention, namely a staining composition including fuchsin and a surfactant, where the surfactant is present in an amount range from about 1w/v% to about 3w/v%.
Akiko teaches that its compositions are free from precipitates for a period of four months. To achieve this, Akiko describes that a pH range of 4.5 to 7.5 is essential to permit sufficient “dyeability” and prevent precipitation. Akiko further describes that a chelator agent is added for the purpose of improving long-term storage stability, such as for four months. Consistent with preventing precipitation Akiko describes that the amount of fuchsin included within any solution is relatively low, such as being present in an amount of 0.005 to 0.2% by mass, such as 0.005 to 0.1% by mass, or such as 0.02 to 0.04% by mass. By controlling the pH, adding a chelator, and maintaining a low concentration of fuchsin, Akiko is able to provide a composition that is free from precipitates for a time period of four months.
From the teachings of Akiko the skilled artisan would appreciate that compositions including fuchsin precipitate unless methods are implemented to prevent or mitigate such precipitation. Raoul teaches that its staining solution keeps well but does not teach any time period and never describes whether its solutions are free form precipitates. Raoul does not teach any reagents or methods that prevent precipitate formation. This notable since Raoul uses a fuchsin concentration that 4.5 times greater that the highest concentration specified by Akiko. The artisan would not have been motivated to look to the teachings of Raoul to increase the concentration of fuchsin with a reasonable expectation of success in maintaining a solution free from precipitates. Accordingly, the obviousness rejection should be withdrawn. (Remarks-pages 10-13).
Applicant’s arguments have been considered but are not found to be persuasive.
The references may not teach a staining composition including fuchsin and a surfactant, where the surfactant is present in an amount ranging from between about 1w/v% to about 3w/v% as in amended claims 1, 17 and 76. However, one of ordinary skill in the art, wanting to use amounts in terms of w/v% can use the conversion formula suggested by the applicant for such a conversion. The formula given by applicant for the conversion will be known to the artisan.
Akiko teaches the use of a broad range for the concentration of the chelating agent to prevent precipitation for 4 months or longer (page 2, see para after the teachings of base for adjusting pH). This means that the concentration of the chelating agent can be adjusted (increased) if higher concentration of fuchsin is used in order to prevent precipitation for a longer period. Raoul teaches that its stock solution keeps well and can be used repeatedly for staining till it is exhausted. This teaching tells the artisan that the composition of Raoul, which has higher concentration of fuchsin, is stable even without the chelating agent. Therefore, if chelating agent in an appropriate amount is included in the composition which has a higher concentration of fuchsin, it should be stable even longer than 4 months since the chelating agent stabilizes (no fuchsin precipitation) according to Akiko. Therefore, the artisan would be motivated to look to the teachings of Akiko to add the base (chelating agent) that is missing in Raoul, and there is reasonable expectation of success in maintaining a solution free from precipitates in the presence of the chelating agent. Raoul need not necessarily teach a reagent to use that prevents formation of precipitate since Akiko teaches it.
Polaske teaches that the surfactant is used keep nonpolar compounds in the solution to remain mixed within the solution and may be used to produce uniform spreading of the reagents across tissue section as well as decrease background staining (para 0067). In addition, the surfactant, which may be an anionic, a cationic or non-ionic surfactant can be selected and when combined with the other components, allows or the desired surface tension to be achieved; does not denature proteins or other reagent components and it provides a low foam height (para 00111). In view of this teaching of Polaske one of ordinary skill in the art can adjust the concentration in terms w/v% to obtain a staining composition that has optimal properties.
The combined teachings of the prior art render the instant claims obvious. The rejection is maintained.
Conclusion
Elected claims 1-20, 23, 76-78 are rejected.
Claims 21-27, 46-47, and 64-75 have been canceled.
Group II Claims 28-45 and 48-63 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693