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 .
Election/Restrictions
Applicant’s election without traverse of Group I with the species of (A) everolimus; (B) medium chain fatty acid triglyceride; (C) gelatin; and reduced sugar syrup (D), in the reply filed on 9/10/24 has been acknowledged.
Claim Status
Claims 6, 7 and 10-12 are cancelled.
Claims 8, 9, 13, 15 and 17 are withdrawn.
Claims 1-5, 14, 16 and 18 are presented for examination.
Withdrawn rejections
Applicant's Declaration under 37 CFR 1.132, amendments and arguments filed 1/15/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-5, 14, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Coulter et al. (US20150132374) and Coulter et al. (US20140234418; hereinafter Coulter2014) and Coulter (US8911777; hereinafter Coulter777) and Kobayashi et al. (US20140328991) and Steinberg et al. (Clinical Therapeutics 2003;25(7):2037-2051) and Daniels, BA (US20130273096) and Mennella et al. (Clin Ther. 2013 August ; 35(8): 1225–1246).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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The claims are being examined with regard to the election of the species (A) everolimus; (B) medium chain fatty acid triglyceride; (C) gelatin; and reduced sugar syrup (D).
Claim interpretation: Because the most common way of describing the amount of an ingredient in a composition of matter is by weight percentage, to facilitate examination the Examiner has determined that the least number of parts is 151.1 and the greatest number of parts is 520. That allows for the conversion of the “parts by mass” to percentage. For example, 100 parts of water-soluble polymer substance (C) for the least number of parts 151.1 converted to a percentage is: (100/151.1) X 100 = 66.2% and the greatest number of parts 520 converted to a percentage is: (100/520) X 100 = 19.2% substance (C). That establishes a range of 19.2-66.2%. Applying that conversion respectively to the rest of the values, the Examiner has determined that the claim reads on 0.066-3.84% of active ingredient (A); 0.66-19.2% hydrophobic liquid (B); 19.2-66.2% water soluble polymer substance (C); and 49.7-57.7% of an excipient (D). Regarding the range of 1 to 50 parts of (B) in claim 16, that is expressed as 0.66-10.6%.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical formulation techniques, components and delivery systems, physiology, disease etiology and treatments and pharmaceutical chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
With regard to instant claim 1-5, 12, 14 and 16 Coulter et al. teach cyclosporine A active ingredient, which is not elected but claimed by applicant as a TDM drug, compositions comprising a matrix (claims 1 and 47-49) with a hydrogel forming polymer matrix of a continuous phase and a disperse phase (claims 66 and 68) where the hydrogel forming matrix is gelatin and agar (claim 96) and can further comprise a polyol excipient such as sorbitol (claim 97) and the disperse phase is medium chain fatty acid triglyceride (caprylic/capric) hydrophobic liquid (claim 100; [0253-0255, 0260-0263, 0272]). Coulter et al. teach that the cyclosporin may be dissolved in the disperse phase or suspended in the disperse phase [0059, 0146, 0149]. Coulter et al. teach that the cyclosporin is dissolved in a hydrophobic material [0355, 0513] or dispersed phase (Claim 82). Coulter et al. teach that the disperse phase is made by mixing a solution of cyclosporine in an oil and mixing the disperse phase into an aqueous phase with the hydrogel forming polymer (claim 101; [0277, 0355]), thus incorporating the active ingredient into the hydrophobic liquid and dispersing the hydrophobic liquid in the water-soluble polymer substance and excipient without any surfactant. Indeed Coulter et al. teach that the hydrogel forming matrix may further comprise a surfactant [0242] and that the oil phase my further comprise a surfactant [0265, 0279] where the permissive language “may” means that the surfactants are optional and not required. In fact, Coulter et al. even teach embodiments without surfactant and mention embodiments “when present” [0370]. Claim 83 states that the core further comprises a surfactant which indicates that surfactants are a new element introduced into the composition of claim 68. Thus, while claim 83 would be excluded from the instant claim language, the embodiment of at least claim 68, which is ultimately dependent upon claim 1, is not excluded and reads on the claimed subject matter.
With regard to instant claims 1 and 18, Coulter et al. provide guidance on the amounts of the components. Regarding the active ingredient cyclosporine, Coulter et al. teach that: “The composition may be formulated into a unit dosage form for oral administration comprising from 0.1 mg to 1000 mg, optionally from 1 mg to 500 mg, for example 10 mg to 300 mg, or 25 to 250 mg suitably about 25 mg, 35 mg, about 75 mg, about 180 mg, about 210 mg or about 250 mg cyclosporine A or from 60-150 mg/g [0079; 0356, 0416, 0421]. Regarding the gelling agent gelatin, Coulter et al. teach that the composition comprises at least 40%, for example 40-70% gelatin [0228] or 300-700 mg/g [0411]. Regarding the hydrophobic liquid medium chain triglycerides, Coulter teach 20-200 mg/g [0412], which is 2-20% and overlaps the claimed range of 1-100 parts by mass or 1-50 parts by mass or 10-100 parts by mass. Regarding the excipients, Coulter et al. teach adding other well-known excipients including taste-masking agents [0335-0341].
Regarding claims 1-3, Coulter2014 teaches that: “The identity of the immunosuppressant is not critical. It may be, or comprise, any one or more of:…cyclosporin A (ciclosporin);…sirolimus derivatives for example everolimus…” [0125].
Regarding claims 1-3, 5 and 14, Coulter777 teach oral compositions comprising tacrolimus (Claim 12) incorporated into a hydrophobic liquid without surfactant (Claims 1 and 9) and gelling agent gelatin (Claims 1 and 7-8) with at least one other active pharmaceutical ingredient such as everolimus and cyclosporins (Claim 23). Coulter777 teach embodiments without a surfactant (Example 8; Table 2). Thus, Coulter777 provide for the teachings of everolimus incorporated into a hydrophobic liquid without a surfactant with a gelatin gelling agent.
Regarding claim 1, Steinberg et al. report that: “patients taking cyclosporine complain about the undesirable odor of the capsule; its large size, making it difficult to swallow; its unpleasant taste” (Page 238, Introduction; Abstract Background; Page 2049 Discussion); and that cyclosporine has been associated with poorer compliance than other immunosuppressive agents primarily due to AEx and unpalatable taste (Page 2039, 1st paragraph). Indeed, Steinberg et al. report: “Many of the patients (39.1% [742/1898]) expressed a desire to stop taking the medication due to the capsule’s unpleasant taste.” (Page 2044, 1st paragraph).
Regarding claim 1, Mennella et al. teach that many active pharmaceutical ingredients taste bitter and are aversive to children and adults thus creating a problem with compliance (Abstract). Mennella et al. teach that to reduce the bitterness of drugs, “masking the bitter taste of medications is a major challenge in formulating liquid medications, drugs are often combined with more pleasant-tasting compounds, for example, sucrose, high-intensity sweeteners” (Page 3, 2nd paragraph). Mennella et al. also cites the old Mary Poppins adage “a spoonful of sugar helps the medicine go down” (Page 5, 2nd paragraph).
With regard to instant claim 1, Kobayashi et al. teach taste improving agents including sorbitol, maltitol, mannitol, and reduced sugar syrup, and reduced sugar syrup is preferred and can be present from about 200-800 parts by mass [0031], which overlaps the claimed range of 100-300 parts by mass of excipient D. MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With further regard to the amount of excipient(s) present, Daniels teaches that: “The amount of any individual excipient in the composition will vary depending on the nature and function of the excipient and particular needs of the composition. Typically, the optimal amount of any individual excipient is determined through routine experimentation, i.e., by preparing compositions containing varying amounts of the excipient (ranging from low to high), examining the stability and other parameters, and then determining the range at which optimal performance is attained with no significant adverse effects. Generally, however, the excipient(s) will be present in the composition in an amount of about 1% to about 99% by weight, preferably from about 5% to about 98% by weight, more preferably from about 15 to about 95% by weight” [0173].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Coulter et al. is that Coulter et al. do not expressly teach 0.1 to 20 parts by mass (0.066-3.84%) or 0.1 to 10 parts by mass of the active ingredient everolimus. This deficiency in Coulter et al. is cured by the teachings of Coulter et al., Coulter2014 and Coulter777.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to add 0.1 to 20 parts by mass (0.066-3.84%) or 0.1 to 10 parts by mass of the active ingredient everolimus, as suggested by Coulter2014 and Coulter777, to the composition of Coulter et al. and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Coulter2014, Coulter777 and Coulter et al. have the same inventor of Coulter and Coulter not only considers cyclosporin and everolimus as immunosuppressant functional equivalents, thus making their substitution and/or combination obvious to the ordinary artisan, but also Coulter777 provide for the teachings of everolimus incorporated into a hydrophobic liquid without a surfactant and with a gelatin gelling agent. Thus, this concept is already in the prior art. “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982). See also MPEP 2144.06(I) COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” In re Susi, 58 CCPA 1074, 1079--80, 440 F.2d 442,445 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77 (1960). As explained in Crockett, the idea of combining them flows logically from their having been individually taught in the prior art. (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). Accordingly, it is obvious to add everolimus or substitute everolimus to the cyclosporine oral dosage form of Coulter et al. with a reasonable expectation of success. With regard to the amounts to add, Coulter et al. teach lower amounts of the active ingredient cyclosporine A [0079] such as from 0.1 mg to 1000 mg or from 1 mg to 500 mg. Therefore, it is merely routine optimization of the surfactant free embodiments of Coulter et al. to have 0.1 to 20 parts by mass (0.066-3.84%) or 0.1 to 10 parts by mass of the active ingredient everolimus in combination with or substituted for the cyclosporine of Coulter et al. dissolved or dispersed in the hydrophobic liquid with a reasonable expectation of success. Pharmaceutical dose has been recognized as a result-effective parameter susceptible to routine optimization. See, e.g., Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989).
Additionally, the amounts of the other components would be adjusted accordingly to the lower amount of active ingredient and it would appear to be nothing more than conventional optimization by the ordinary artisan to add enough of each component to achieve the desired result within the parts by mass instantly claimed especially when Coulter et al. provide a starting point for optimization as discussed above.
2. The difference between the instant application and Coulter et al. is that Coulter et al. do not expressly teach adding 100 to 300 parts by mass (49.7-57.7% by weight) reduced sugar syrup excipient to the composition. This deficiency in Coulter et al. is cured by the teachings of Kobayashi et al., Steinberger et al., Mennella et al. and Daniels.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to add 100 to 300 parts by mass reduced sugar syrup to the composition of Coulter et al., as suggested by Kobayashi et al., Steinberger et al., Mennella et al. and Daniels, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationale.
First, the active ingredient cyclosporin of Coulter et al. has an unpleasant taste which creates patient compliance issues as taught by Steinberg et al. Coulter et al. also suggests adding well-known taste masking agents.
Secondly, adding sugars/sweeteners to make unpleasant tasting pharmaceuticals more palatable is not only universal common sense but also taught by Mennella et al.
Thirdly, Kobayashi et al. direct the artisan to reduced sugar syrup as a preferred taste-improving agent in an amount of about 200-800 parts by mass. Thus, reduced sugar syrup is well-known taste improving agent.
Fourthly, optimizing the amount of any excipient, which would include sweeteners, is routine for the pharmaceutical artisan as taught by Daniels.
Accordingly, the ordinary artisan in view of the combined references would add the well-known taste improving agent reduced sugar syrup in the amounts claimed to the unpleasant tasting cyclosporin formulation of Coulter et al. to increase palatability and patient compliance with a reasonable expectation of success.
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.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Declaration and Arguments:
Applicant's Declaration under 37 CFR 1.132, amendments and arguments filed 1/15/26 are acknowledged and have been fully considered but are not persuasive.
First, the Examiner will simplify the backdrop of the rejection and then secondly address Applicant’s Declaration and arguments. The prior art of Coulter et al. serves as the primary references and teaches compositions of cyclosporin A active ingredient (A), medium chain triglycerides hydrophobic liquid (B), gelatin/agar water-soluble polymer substance (C) and excipients (D), which include taste masking agents. It is known in the art through the teachings of Steinberg et al. that cyclosporin A has an unpleasant taste. It is known in the art through the teachings of Kobayashi et al., Mennella et al. and Daniels to employ taste improving agents including sorbitol, maltitol, mannitol, and reduced sugar syrup, where reduced sugar syrup is preferred and can be present from about 200-800 parts by mass. Consequently, adding about 200-800 parts by mass of the reduced sugar syrup as a taste masking agent to make the unpleasant tasting active agent of Coulter et al. more palatable is obvious to do for the ordinary artisan with a reasonable expectation of success. This is merely applying known techniques in a predictable way where success is expected by the ordinary artisan.
The Declaration under 37 CFR § 1.132 by Shunsuke Sei has been carefully considered but is not persuasive.
In paragraph 6 of the Declaration, the Declarant asserts that Coulter teaches softeners or plasticizers (component D) that if utilized are ideally incorporated in a proportion rising to 30%, i.e., 50 parts by mass of excipient (D) which is outside the claimed range of 100-300 parts by mass. Respectfully, the Examiner is not relying upon Coulter et al. teaching plasticizers or softeners for excipient (D). Rather, the Examiner has pointed out the excipient section of Coulter et al. teaching taste-masking agents and the Examiner has brought in secondary references teaching not only the elected species but also the amount of about 200-800 parts by mass which overlaps the claimed range.
In paragraph 7 of the Declaration, the Declarant presents data that allegedly shows the criticality of the excipient (D) in relation to the other components in forming the composition. The Declarant reproduced Example 1 of Coulter [0432] and the measured the roundness of the resulting particles where the close the roundness value approaches zero, the closer the shape of the particulate is to a perfect sphere. The data shows average roundness values of 0.094 to 0.469 for experiments #1-5 and 0.622 for the Coulter example. Experiments #2-5 are within the claims 100-300 parts by mass of limitation and showed excellent formability whereas formability was “not sufficiently good” in experiment #1 and the Coulter example showed inferior formability. The Examiner has carefully considered the Declaration data and has this response. Initially, the Examiner notes that the Declaration data is not commensurate is scope with the claims. There is no adequate basis for reasonably concluding that the great number and variety of compositions included by the claims would behave in the same manner as the single tested composition. In other words, Applicant has not shown that based on this single example, it is reasonable to expect that other embodiments falling within the scope of the claims will behave similarly. Thus, even if the results were unexpected, they are not commensurate with the scope of the claims. "The evidence presented to rebut a prima facie case of obviousness must be commensurate in scope with the claims to which it pertains." In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). See MPEP 716.02(d). Thus, the Declaration fails on this point. Secondly, the Examiner notes that the independent claim does not require any particular roundness or sphericity but rather are directed to an oral pharmaceutical composition. Lastly, the Declaration does not demonstrate that the composition of Coulter is unfit for its intended purpose. So, while the Declaration shows one embodiment of Coulter has a less spherical particle than some of the Declarant’s tested examples, it does not show that the composition of Coulter would not function as an oral pharmaceutical composition. In fact, the Declaration shows that the Coulter example has an average diameter (3.54, 3.80 and 4.20) of the same scale as Applicant’s tested examples. For at least these reasons the Declaration is not probative.
On pages 6-7 of remarks, Applicant asserts that the Examiner has failed to make a prima facie case of obviousness because: “A mere conclusion that a claimed invention is obvious because claimed limitations can be found in the prior art and that the person of ordinary skill has good reasons to pursue the known options within his or her technical grasp is not sufficient. Rather, the Examiner fails to provide sufficient grounds explaining why the skilled person would be motivated to modify the teachings of Coulter based on his own teachings or that of Kusuda and arrive at the instantly claimed invention with a reasonable expectation of success.” The Examiner notes for the clarity of the record that “Kusuda” was inadvertently substituted for Kobayashi. It is clear that the rejection is over the combination of reference with Kobayashi. On page 7 of remarks, Applicant argues hindsight by the Examiner. However, the Examiner has shown only through the teachings of the prior art not only convey or suggest how each and every limitation is met but also provide a reason to combine the references. In this case, to provide a taste masking agent to make an unpleasant tasting active agent more palatable. So, the Examiner has properly met his burden without hindsight.
On pages 7-10 of remarks, Applicant argues that the cited references fail to teach or suggest the elements of claim 1 as claimed. Applicant discusses the Coulter references and calculates the percentage amount of components in various formulations showing a normalized (D) of around 11.5-11.7 parts per 100 parts (C) for Coulter ‘374. Similar calculations were performed for Coulter ‘418 and Coulter ‘777. Applicant stresses on the bottom of page 9 that Coulter ‘374 teaches softeners or plasticizers rising to 30% and preferably 1.5-3% sorbitol. On page 10, Applicant asserts that: “None of the Coulter references exemplify or suggest increasing (D) to the claimed levels; instead, (D) is used sparingly as a plasticizer to aid processing, not as a major component for dispersion stability or taste masking.” Respectfully, the Examiner cannot agree because while Coulter et al. do teach softeners or plasticizers like sorbitol, if utilized, can be ideally incorporated in a proportion rising to 30%, Coulter et al. also separately teach and suggest adding taste-masking agents under an entirely different heading (See page 29, [0335 and 0341] “Other Excipients”). Coulter et al. is silent on the amount of taste-masking agent to add and leaves that to the ordinary artisan to figure out. The Examiner has shown through the secondary references that the amount of taste-masking agent excipient is routinely optimized and can be from about 200-800 parts by mass. Consequently, this is simply application of conventionally known pharmaceutical taste-masking excipients by the ordinary artisan with a predictable expectation of success.
On pages 10-11, Applicant argues that the artisan would have to completely reformulate the Coulter composition to include more (B) than (A) and more (D) than (C) with no teachings by Coulter to make those changes and no reasonable expectation of success. Respectfully, the Examiner does not agree because as described above, Coulter et al. provide guidance on the amounts of the components. Regarding the active ingredient cyclosporine, Coulter et al. teach that: “The composition may be formulated into a unit dosage form for oral administration comprising from 0.1 mg to 1000 mg, optionally from 1 mg to 500 mg, for example 10 mg to 300 mg, or 25 to 250 mg suitably about 25 mg, 35 mg, about 75 mg, about 180 mg, about 210 mg or about 250 mg cyclosporine A or from 60-150 mg/g [0079; 0356, 0416, 0421]. Regarding the gelling agent gelatin, Coulter et al. teach that the composition comprises at least 40%, for example 40-70% gelatin [0228] or 300-700 mg/g [0411]. Regarding the hydrophobic liquid medium chain triglycerides, Coulter teach 20-200 mg/g [0412], which is 2-20% and overlaps the claimed range of 1-100 parts by mass or 1-50 parts by mass or 10-100 parts by mass. Consequently, there is room for optimization which is well within the pharmaceutical artisan’s purview.
On pages 11-14 of remarks, Applicant discusses the secondary references and argues hindsight. The Examiner has addressed the hindsight arguments above. With regard to the secondary references, Applicant asserts that the secondary references provide no specific formulations, key ratios, relevant structures and are irrelevant as non-analagous art. It is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). The secondary references are relied upon as presented in the rejection and not as characterized by Applicant. The secondary references constitute analogous pharmaceutical art as relied upon by the Examiner. Applicant argues that: “One skilled in the art would not disrupt the Coulter balance by massively increasing (D), especially without evidence of improved stability or efficacy. However, it is the Examiner’s position that Coulter teaches from 0.1 mg to 1000 mg of cyclosporin A active agent (Claim 110) where the lower amount of 0.1 mg leaves a generous amount for other components to make the dosage form. So, it is not a stretch to increase the amount of excipients in the formulation of Coulter. As argued previously, the presence of a surfactant in the composition of Coulter is a separate embodiment and not required.
On pages 14-15 of remarks, Applicant discusses the Sei Declaration. The Examiner has carefully considered the Sei Declaration and found it no probative for the reasons explained in detail above. Applicant’s arguments did not change the Examiner’s position.
On pages 15-16 of remarks, Applicant argues claims 2-5, 14, 16 and 18 separately. With regard to claims 2-5, the claims are being examined as they read upon the elected subject matter. With regard to claim 14 that requires no surfactant, Coulter teach embodiments with no surfactant. With regard to claim 16 and 18, the ranges were addressed in the rejection.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613