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 . 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.
Priority
The instant application is a 371 of PCT/US2021/030447 filed 05/03/2021 and claims domestic benefit to US provisional application no. 63/018,920 filed on 05/01/2020.
Status of the Claims
The claim amendments and remarks filed on 11/10/2025 is acknowledged. Claims 1, 6, 8-17, and 21 are amended. Claims 2-5, 7, and 22-23 are canceled, claims 24-26 are newly added.
Accordingly, claims 1, 6, 8-21, and 24-26 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 102 rejections over Beech for claims 1-3, 8-13, and 15 and over Kusakabe for claims 1-3, 9-13, and 16 are withdrawn in view of claim 1 now requiring the formulation to be a nasal spray and also including a thickening agent, wherein the ratio of the cyclodextrin to the thickening agent is a new ratio range of 10:1 to about 15:1, which has changed the scope of the instant claims. Additionally, the scope of the cyclodextrin derivative has been narrowed to be a concentration of 2.5%-10% as well as being one or more of hydroxypropyl-beta-cyclodextrin or 2-hydroxypropyl-gamma-cyclodextrin.
The 35 USC 103 rejections over Beech for claims 1-6, 8, and 15, over Beech in view of Carrouel for claims 16-20, and over Beech in view of Namburi for claim 14, and over Kusakabe in view of Kundoor and Inthavong for claims 1 and 16-21 are withdrawn in view claim 1 now requiring the formulation to be a nasal spray and also including a thickening agent, wherein the ratio of the cyclodextrin to the thickening agent is a new ratio range of 10:1 to about 15:1, which has changed the scope of the instant claims. Additionally, the scope of the cyclodextrin derivative has been narrowed to be a concentration of 2.5%-10% as well as being one or more of hydroxypropyl-beta-cyclodextrin or 2-hydroxypropyl-gamma-cyclodextrin.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “wherein the cyclodextrin derivative is one or more selected from the group consisting of hydroxypropyl-beta-cyclodextrin or 2-hydroxypropyl-gamma-cyclodextrin, ; a thickening agent … “.
The comma before the semicolon should be removed.
Appropriate correction is required.
The following grounds of rejections are new as necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 10, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “The nasal spray formulation of claim 5 …”.
Claim 6 is indefinite because claim 5 is now cancelled, making it unclear what the metes and bounds of the claim are.
For purposes of examination, claim 6 is being interpreted as being dependent upon claim 1.
Claim 10 recites “The nasal spray formulation … wherein the mucocutaneous lining is a surface of one or more of a nasal cavity, an oropharyngeal cavity, a gastrointestinal cavity, a bronchial cavity, a pulmonary cavity, an oral cavity, a rectal cavity, a vaginal cavity, or an ocular cavity”, and claim 18 recites “The method of claim 17 wherein the coating is formed on a mucocutaneous lining of a surface of one or more cavities selected from a nasal cavity, an oropharyngeal cavity, a gastrointestinal cavity, a bronchial cavity, a pulmonary cavity, an oral cavity, a rectal cavity, a vaginal cavity, or an ocular cavity”.
Claims 10 and 18 are indefinite because these claims now require a “nasal spray formulation”, and while it is clear the nasal spray formulation forms a coating on the nasal cavity, it is unclear how the nasal spray formulation is able to coat any of the other recited cavities.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 recites “The nasal spray formulation of claim 1 comprises an aerosol, inhalant, intranasal spray, eyedrop, gel, ointment, wash, lozenges, powder, tablets, capsules, pessaries, aqueous, spray, or suppository”.
Instant claim 1 (claim 15 depends from claim 1) now requires a “nasal spray formulation”. Here, the nasal spray formulation can be further limited to comprise an aerosol, inhalant, intranasal spray, or aqueous spray. However, the nasal spray formulation is unable to be limited to comprise an eyedrop, gel, ointment, wash, lozenges, powder, tablets, capsules, pessaries, or suppository, unless the structural form of the formulation is changed from a nasal spray formulation and therefore would fail to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 6, 8-12, 14-20, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023) in view of Namburi et al. (US20060120967A1 in IDS filed 08/11/2023).
Vitins discloses various formulations comprising one or more cyclodextrins, said formulations being particularly useful for treating or preventing viral infections. In specific embodiments, the formulations comprise non-water based gels, throat and nose sprays, nose gels, lip balms, and emulsions (see Abstract). Vitins discloses that their compositions can be used to treat viral infections such as hepatitis virus (HBV or HCV) (paragraph 0007). Vitins discloses that cyclodextrins, while not falling into the traditional antiviral categories, have been found effective at treating and preventing diseases caused by infectious viral agents (paragraph 0005). Therefore, Vitins discloses that it would be useful to have antiviral compositions provided in specific formulations that specifically target the areas associated with “breakouts” of various viral conditions and that are also convenient and discrete (paragraph 0005). Vitins discloses that their compositions can reduce duration of an active break associated with a viral infection or prevent recurrent viral breakouts, which meets the limitation of a method of reducing a risk of a microbial infection as recited in instant claim 16.
Vitins discloses a nasal spray composition comprising 2.5% - 7.5% by weight of one or more cyclodextrins, one or more polyols, and water (claims 9-10 and 14). Vitins further discloses that this composition does not include any additional active agents (claim 16). Vitins discloses that the cyclodextrin is preferably hydroxypropyl-beta-cyclodextrin (paragraph 0025)
Vitins also discloses a nose gel composition comprising 2.5% - 7.5% by weight of one or more cyclodextrins, a carrier, and a thickener (claims 17-18). Vitins discloses that this composition does not include any additional active agents (claim 22). Vitin discloses that their hydrogel formulations comprise carriers or solvents in combination with one or more thickeners or gel forming agents (paragraph 0082). Vitins discloses that the gel forming agent can include methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, and others (paragraph 0082).
The difference between Vitins and the claimed invention is that while Vitins discloses a nasal spray composition comprising the cyclodextrin, Vitins does not necessarily disclose a nasal spray composition that further includes a thickening agent and also does not disclose a thickening agent in the recited wt ratios.
Namburi discloses a method for treating diseases or conditions of the oral cavity, throat, or nose comprising administering a spray composition that includes cyclodextrin in an amount of from about 0.1% w/v to about 20% w/v; at least one essential oil in an amount of from about 0.001% w/v to about 5.0% w/v; an effective amount of an antimicrobial preservative composition; and water (see Abstract). Namburi discloses that the composition is suitable for either oral or intranasal spray administration and can further comprise a mucoadhesive polymer thickening agent in an amount from 0.2% to 2.0% w/v (claim 1 and paragraph 0017). Namburi discloses the mucoadhesive polymer thickening agent can be cellulose derivatives such as hydroxylmethyl cellulose and others (paragraph 0017). Namburi teaches that the mucoadhesive polymer thickening agent is added to achieve a longer residence time in the nose and to avoid dripping of spray liquid in the nose (paragraph 0017). Namburi discloses that a useful pH range for a nasal formulation is from about 4.5 to about 7.0 (paragraph 0031). Namburi discloses their finished formulation can be filtered through filtered through appropriate filter and the compositions are filled into commercially available bottles and fit with metered dose pumps for oral or nasal delivery of the drug products, which meets the limitation of a specialized device recited in instant claim 17.
Namburi et al. also discloses that their composition may optionally comprise an astringent and that useful astringents include zinc gluconate, zinc chloride, zinc acetate, and others (paragraph 0023), which meets the limitation of a zinc containing compound. Namburi also discloses that the astringent may be present in amounts of 0.1% to 10% w/v. Namburi et al. provides an exemplary sore throat spray composition that includes 0.05% zinc acetate (see Example 3 in paragraph 0038).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the nose gel composition of Vitin to be a nasal spray composition as disclosed in Namburi and further optimize the weight ratio of cyclodextrin to gel forming agent such as hydroxyethyl cellulose based on the amounts disclosed in Vitin and Namburi to arrive at the claimed invention. One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because both Vitin and Namburi disclose similar nasal spray compositions comprising cyclodextrins that are useful for treating diseases and conditions of the nasal cavity, and Namburi provides further guidance of nasal spray compositions that include thickeners. Therefore, an ordinary skilled artisan could have predictably modified the nose gel composition of Vitin to be a nasal spray composition with a reasonable expectation of success. Furthermore, an ordinary skilled artisan could have performed routine optimization to arrive at the recited weight ratios of cyclodextrin to thickening agent based on Vitin disclosing a cyclodextrin amount of 2.5% - 7.5% by weight and Namburi discloses a thickening agent amount of 0.2% - 2.0% by weight. See MPEP 2144.05 II.
In regards to instant claims 9-12, the claimed functional feature of “forms a coating over a mucocutaneous lining, thereby preventing entry of a microbe or of a gaseous agent into the cell” would flow naturally from the combined teachings of Vitin and Namburi because the combined teachings provide guidance of administering the claimed nasal spray formulation in the same amounts as described above to the same nasal cavity of a subject suffering from a viral infection such as HCV or HBV.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 14, it would have also been prima facie obvious before the effective filing date of the claimed invention to combine the nasal spray composition as disclosed by the combined teachings of Vitin and Namburi described above with the composition comprising 0.05% zinc acetate of Namburi et al. because Namburi teaches that their nasal spray compositions can include an astringent such as zinc acetate, and both Vitin and Namburi disclose compositions that comprise cyclodextrins that are useful for the same purpose of treating diseases and conditions of the nasal cavity. See In re Kerkhoven, MPEP 2144.06 section I.
In regards to instant claims 16-20, it would have also been prima facie obvious before the effective filing date of the claimed invention to have administered the nasal spray composition product as disclosed by the combined teachings of Vitin and Namburi described above to reduce duration of an active break associated with a viral infection such as HCV or HBV or prevent recurrent breakouts of these viruses as disclosed in Vitin to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vitin provides guidance of nasal spray compositions comprising cyclodextrin as the active agent to treat or prevent viral infections.
Furthermore, the limitations “forms a coating over a mucocutaneous lining, thereby preventing entry of a microbe or of a gaseous agent into the cell” and “contact the cells susceptible to infection” would flow naturally from the combined teachings of Vitin and Namburi because the combined teachings provide guidance of administering the claimed nasal spray formulation in the same amounts as described above to the same nasal cavity of a subject suffering from a viral infection such as HCV or HBV.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 24, even though the combined teachings of Vitin and Namburi described above do not exemplify a nasal spray formulation “consisting of” the cyclodextrin and carrier, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the nasal spray composition as disclosed by the combined teachings of Vitin and Namburi described by excluding out other ingredients except for the cyclodextrin and carrier as suggested in Vitin to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vitin provides guidance that the cyclodextrin may be used as the active agent for treating a viral infection and explicitly discloses that their compositions do not include any additional active agents.
In regards to instant claim 25, even though the combined teachings of Vitin and Namburi described above do not exemplify a nasal spray formulation “consisting of” the cyclodextrin, a cellulose derivative, and carrier, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the nasal spray composition as disclosed by the combined teachings of Vitin and Namburi described above by selecting only the cyclodextrin, cellulose derivative, and carrier to be in the nasal spray formulation as suggested in Vitin and Namburi and further prepare the cellulose derivative in amounts disclosed in Namburi to arrive at the claimed invention. One of ordinary skill in the art would have made this modification of only selecting a cyclodextrin derivative and carrier with a reasonable expectation of success because Vitin provides guidance that the cyclodextrin may be used as the active agent for treating a viral infection and explicitly discloses that their compositions do not include any additional active agents. Furthermore, one of ordinary skill in the art would have been motivated to add a cellulose derivative because Namburi provides guidance that the mucoadhesive polymer thickening agent such as a cellulose derivative is added to achieve a longer residence time in the nose and to avoid dripping of spray liquid in the nose. One of ordinary skill in the art would have a reasonable expectation of success because Namburi discloses similar nasal spray compositions that include the same cyclodextrin derivative. Lastly, Namburi provides guidance of an overlapping range of 0.2% - 2.0% by weight for the cellulose derivatives. See MPEP 2144.05 I.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023) in view of Namburi et al. (US20060120967A1 in IDS filed 08/11/2023), as applied to claims 1, 9, and 11-12 above, and further in view of Carrouel et al. (Journal of Clinical Medicine, published 04/15/2020 in PTO-892 dated 07/14/2025).
The combined teachings of Vitins and Namburi are as described above and teach the nasal spray formulation recited in instant claims 1, 9, and 11-12 as discussed above.
The combined references, however, do not disclose wherein the virus is SARS-CoV-2 virus and variants thereof.
Carrouel discloses the use of mouthrinses and/or nasal applications containing beta-cyclodextrin and Citrox for preventing infection and progression of COVID-19 (see Abstract). Carrouel discloses that mouth rinses containing oxidative agents such as amphiphilic cyclodextrins, appear indicative for the purpose of reducing the salivary load of oral microbes (see page 5 second paragraph). Carrouel discloses that cyclodextrins attract viruses before irreversibly inactivating them and that by disrupting the outer shell of a virus, they can destroy infectious particles by simple contact, rather than just blocking viral growth (see page 5 second paragraph). Carrouel discloses that this property of beta-cyclodextrins can potentially be exploited for the reduction of viral load in the oral cavity with the use of disinfectant solutions (see page 5 second paragraph). Carrouel discloses that in addition, the use of therapeutic oral biofilm rinses and/or nasal applications might be considered in preventing viral transmission via the oropharyngeal route (see page 5 second paragraph).
It would have been prima facie obvious before the effective filing date of the claimed invention to have applied the nasal spray composition as disclosed by the combined teachings of Vitin and Namburi described above for preventing infection and/or progression of COVID-19 as suggested in Carrouel to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vitin provides guidance that even though cyclodextrin are not known as traditional antiviral agents, they have been found effective at treating and preventing diseases caused by infectious viral agents, and Carrouel provides further guidance that cyclodextrins can be exploited for the reduction of viral load in the oral cavity and suggest its use for nasal applications to treat COVID-19 patients.
Furthermore, the claimed functional feature of “forms a coating over a mucocutaneous lining, thereby preventing entry of a microbe or of a gaseous agent into the cell” would flow naturally from the combined teachings of Vitin, Namburi, and Carrouel because the combined teachings provide guidance of administering the claimed nasal spray formulation in the same amounts as described above to the same nasal cavity of a subject suffering from SARS-CoV-2 virus.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023) in view of Namburi et al. (US20060120967A1 in IDS filed 08/11/2023), as applied to claims 1 and 16-17 above, and further in view of Kundoor et al. (Pharm Res, 2011 in PTO-892 dated 07/14/2025) and Inthavong et al. (Aerosol Science and Technology, 2006 in PTO-892 dated 07/14/2025).
The combined teachings of Vitins and Namburi are as described above and teach the nasal spray formulation recited in instant claims 1, 9, and 11-12 as discussed above.
The combined references, however, do not disclose wherein the formulation is an aerosolized particulate delivered to the cells with the recited parameters in claim 21.
Kundoor et al. discloses the effect of formulation and administration-related variables on nasal spray deposition using a nasal cast (see Abstract). Kundoor et al. discloses that there is a need to systemically evaluate parameters of nasal administration for efficient drug delivery into the nasal cavity (see page 1895 right column to page 1896 left column). Kundoor et al. demonstrates the effect of nasal spray insertion depths ranging from 0 mm – 15 mm (see paragraph 1902 right column and Fig. 11 on page 1901). Kundoor et al. shows that an insertion depth of 10 mm had the highest deposition area. Kundoor et al. discloses that nasal spray pumps delivering larger volumes (100 microliters) had significantly greater nasal deposition area compared to nasal spray pumps delivering 50 microliters (page 1902 right column and Fig 13 on page 1902).
Inthavong et al. discloses a numerical study of spray particle deposition in a human nasal cavity (see Abstract). Inthavong et al. discloses that particle depositional studies from nasal sprays are important for efficient drug delivery (see Abstract). Inthavong et al. demonstrates in Fig. 10 on page 1043 the deposition patterns for 15 micrometer and 20 micrometer particles released at 10 m/s with spray cone angles of 20 degrees and 80 degrees (note: the claimed spray cone angle recited in claim 21 of π/4 to π/2 corresponds to of 45 degrees to 90 degrees). Inthavong et al. discloses that when the spray cone angle was at 80 degrees for 20 micrometer particles, a wider area of deposition was observed in the frontal zones, whilst those particles projected favorably towards the nasal valve and was able to travel beyond the 90-degree bend (see page 1043, right column).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the nasal spray composition product as disclosed by the combined teachings of Vitin and Namburi described above to have a 10mm insertion depth, 100 microliter spray volume, 10 m/s spray velocity, and 80 degree spray cone angle as disclosed in Kundoor and Inthavong to arrive at the claimed invention. One of ordinary skill in the art would have been motivated make these modifications because both Kundoor and Inthavong express a need to optimize intranasal administration for more efficient drug delivery uptake. One of ordinary skill in the art would have a reasonable expectation of success because both Kundoor and Inthavong demonstrate that the described spray parameters result in increased deposition area in the nasal cavity for a nasal spray product.
Response to Arguments
Applicant’s arguments filed on 11/04/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant has presented several arguments against the rejections made in the previous Office Action. However, these rejections have been withdrawn in view of instant claim 1 now requiring the formulation to be a nasal spray and also including a thickening agent, wherein the ratio of the cyclodextrin to the thickening agent is a new ratio range of 10:1 to about 15:1, which has changed the scope of the instant claims. Additionally, the scope of the cyclodextrin derivative has been narrowed to be a concentration of 2.5%-10% as well as being one or more of hydroxypropyl-beta-cyclodextrin or 2-hydroxypropyl-gamma-cyclodextrin.
Furthermore, the new rejections use Vitins as the primary reference and not Beech or Kusakabe. Therefore, Applicant’s arguments are rendered moot.
Conclusion
No claim is found allowable.
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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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693