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 .
Election/Restrictions
Applicant’s election of rifamycin as the elected rifamycin compound and buffer salt as the elected pharmaceutically acceptable carrier in the reply filed on 04/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application is a U.S. National Phase Application under 35 U.S.C. §371 of
International Patent Application No. PCT/JP2021/047323 filed on December 21, 2021, which claims priority to Japanese Patent Application No. 2020-211571 filed on December 21, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/06/2024 and 01/13/2026 has been considered by the examiner.
Status of Claims
Claims 1-11 are pending and under examination.
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
The disclosure is objected to because it contains laudatory language which may be considered improper. For example, paragraph [0012] refers to “novel features.” Appropriate correction is required.
The disclosure is also objected to because the terms “Tween 80” and “Carbopol 934P or 974P” appearing in the specification, including paragraph [0069] and Tables 1 and 2, constitute trademark or trade name terminology. Use of trademarks or trade names in a patent application is improper because such terminology may not have a precise or permanent meaning and may therefore render the disclosure unclear. Applicant is required to replace all trademark or trade name terminologies with the appropriate generic terminology.
The abstract of the disclosure is objected to because it is not directed to a concise statement of the technical disclosure. The abstract contains unnecessary detail and claim style language, including extensive listing of ingredients and concentration ranges. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The abstract of the disclosure is further objected to because it contains incomplete and reductant sentence structure, for example: “Provided is an ophthalmic composition comprising a rifamycin compound. A topical eye drop composition…” A cleaner abstract should normally combine those into a single concise sentence. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 6 is objected to because of the following informalities: the phrase “which is used for” is awkward and unclear in the context of a composition claim. Appropriate correction is required. Applicant may wish to amend the claim to recite “where in the composition is used for.”
Claim 7 is objected to because of the following informalities: the term “a pH buffer agent” is unclear and lacks proper grammatical form. Appropriate correction is required. Applicant may wish to amend the claim to recite “a buffering agent” or “a pH-adjusting agent,” as appropriate.
Claim 10 is objected to because of the following informalities: the phrase “A medicament for treatment of an ocular disease” is grammatically awkward. Appropriate correction is required. Applicant may wish to amend the claim to recite “A medicament for treating an ocular disease.”
Claim Rejections - 35 USC § 112
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 1-11 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.
With respect to claim 1, the claim recites that the concentration (% by weight) of the nonionic surfactant and the concentration (% by weight) of the rifamycin compound “satisfy the equation represented by the following formula (2)”:
YNis = ax3 + bx2 +cx + d
Wherein YNis represents the concentration of the nonionic surfactant and x represents the concentration of the rifamycin compound. However, the claim fails to clearly define the relationship between the actual concentration of the nonionic surfactant in the claimed composition and the calculated YNis value. Specifically, it is unclear whether the concentration of the nonionic surfactant must be exactly equal to the calculated YNis value, greater than the calculated value, less than the calculated value, within a range of the calculated value, or otherwise mathematically related thereto. Accordingly, one of ordinary skill in the art would not reasonably be apprised of the metes and bounds of the claimed invention.
Furthermore, claim 1 fails to clearly define the meaning and role of variables “a,” “b,” “c.” and “d” in formula (2). Although the claim later recites numerical groupings identified as “(a, b, c, d) (pH),” the claim does not expressly define these variables as coefficients of formula (I), nor clearly explain how the recited numerical values correspond to the claimed equation. Accordingly, the scope and meaning of the claimed mathematical relationship are unclear.
Additionally, claim 1 recites under condition (i) at pH 8.0, the following coefficient set: “(-0.0364, 0.5336, 1.5747x, 0.2939) (pH8.0)” wherein the claim indicates that the recited values correspond to “(a, b, c, c)” in Formulate (2). However, the third value is recited as “1.5747x,” which improperly includes the variable “x” within the coefficient itself, thereby rendering the scope and meaning of Formula (2) unclear. It is therefore indefinite whether the coefficient “c” is intended to be “1.5747” or “1.5747x” and whether the formula is intended to include an additional multiplication by “x.”
Moreover, claim 1 recites that “the rifamycin compound or a pharmaceutically acceptable salt thereof is stably dissolved in the aqueous solution formulation.” The phrase “stably dissolved” is indefinite because the claim fails to provide an objective standard or boundary by which stability is measured. For example, the claim does not specify a duration, storage condition, precipitation threshold, assay retention value, or objective criterion by which one of ordinary skill in the art could determine whether a composition falls within the scope of the claim.
With respect to claim 1, the claim recites in conditions (iii) and (iv) that the composition “does not comprise such an ionic surfactant.” However, the phrase “such an ionic surfactant” lacks clear antecedent basis and renders the scope of the claim unclear because it is indefinite whether the limitation refers to any ionic surfactant, only specifically recited ionic surfactants, or merely intentionally added ionic surfactants. Additionally, the phrase “does not comprise” fails to clarify whether trace, residual, impurity-level, or incidental amounts of ionic surfactants are excluded from the scope of the claims. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention.
With respect to claim 2, the claim recites “0% (not comprise) to 0.0005% by weight” and “0% (not added) to 15% by weight.” The foregoing language renders the scope of the claim unclear because it is indefinite whether “not comprise” requires complete absence of the surfactant or merely absence of intentional addition thereof. Likewise, “not added” is unclear because the claim fails to specify whether incidental or impurity-level amounts are encompassed by the claim scope. Further, the phrase “0% (not comprise)” is grammatically unclear.
Claims 1-11 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.
Claim 1 broadly encompasses aqueous ophthalmic solution formulations comprising any rifamycin compound selected from rifamycin, rifaximin, rifabutin, rifapentine, or a pharmaceutically acceptable salt thereof, wherein the rifamycin compound is “stably dissolved” and wherein the concentrations of the rifamycin compound and anionic surfactant satisfy generalized polynomial relationships over broad formulation conditions including pH 2-12, multiple surfactant conditions, and multiple buffer systems.
Claim 2 also broadly covers aqueous ophthalmic solution formulations comprising any rifamycin compound selected from rifamycin, rifaximin, rifabutin, rifapentine, or a pharmaceutically acceptable salt thereof, wherein the rifamycin compound is “stably dissolved” and, wherein the concentrations of the rifamycin compound and anionic surfactant satisfy generalized relationships of (A1) and (A2) over broad formulation conditions including pH 2-12.
However, the specification primarily describes and exemplifies rifamycin formulations. In particular, paragraphs [0104]-0196] and Tables 1-2 describe formulation studies and mathematical relationships derived from rifamycin-containing formulations under selected conditions. The Examples likewise focus on rifamycin formulations utilizing selected surfactants (e.g., polysorbate 80 aka Tween 80) and selected buffer conditions (e.g., boric acid-borax or boric acid-NaOH), NaCl, EDTA, Benzalkonium chloride, L-ascorbic acid.
The specification does not provide representative, stability data, dissolution data, or mathematical modeling data for rifabutin, rifapentine, rifaximin, or pharmaceutically acceptable salts thereof. Nor does the specification reasonably demonstrate the generalized polynomial relationships recite in claim 1 and the generalized relationships for (A1) and (A2) recited in claim 2 apply across the full scope of the claimed rifamycin genus.
Although the claims encompass formulations having pH values from 2-12, the specification provides coefficient tables and experimental data only for selected pH values approximately between pH 3 and pH 8. The specification therefore does not reasonably demonstrate possession of formula that satisfy the claimed mathematical relationships and the claimed (A1) and (A2) throughout the entire claimed pH range, particularly at pH 2 and pH 9-12.
Furthermore, the claims broadly encompass multiple formulation permutations including formulation containing ionic surfactants, formulations lacking ionic surfactants, nonionic surfactants, boric acid buffer systems, non-boric acid buffer systems, and broad surfactant concentration ranges. However, the specification provides only limited representative examples utilizing selected conditions such as pH 3.32 to pH 8.7 and selected excipients such as benzalkonium chloride, boric acid-NaOH, boric acid-borax, EDTA, Tween 80, and NaCl at specific concentrations. The specification therefore fails to reasonably convey possession of the full breadth of the claimed formulation genus and the generalized mathematical and A1 and A2 relationships recited therein.
With respect to claims 6-11, the claims broadly recite treatment and medicament uses for numerous ocular diseases and conditions including age-related macular degeneration, diabetic retinopathy, retinal detachment, tissue fibrosis, neoplasm, brain damage, and glaucoma-related conditions. However, the specification primarily describes ocular delivery and selected retinal neovascularization-related findings. The specification does not p0rocide representative therapeutic examples, mechanistic data, or sufficient correlation demonstrating treatment of retinal detachment, neoplasm, tissue fibrosis, or the full breadth of the recited disease genus.
Accordingly, the specification fails to reasonably convey to one of ordinary skill in the art that Applicant had possession of the full scope of the claimed invention at the time of filing.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a topical eye drop formulation comprising rifamycin at an amount of 0.5% by weight, Tween 80 at an amount of 0.5% by weight, EDTA at an amount of 0.1% by weight, benzalkonium chloride at an amount of 0.01% by weight, NaCl at an amount of 0.9% by weight, Boric acid-borax at an amount of 50 mM or boric acid-NAOH at an amount of 100 mM at a pH of 3 to 8 for treating age-related macular degeneration in in rabbit, does not reasonably provide enablement for the full scope of the claimed formulation and the claimed ophthalmic diseases/conditions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In determining whether the experimentation required would be undue, the factors set forth in in re Wands, 858 F.2d 731, 737 (Fed. Circ. 1988), have been considered.
The breadth of the claims is extremely large. Claim 1 and 2 broadly encompass multiple rifamycin compounds and pharmaceutically acceptable salts thereof, pH values from 2 to 12, multiple ionic and nonionic surfactant systems, multiple buffer systems including boric acid and non-boric acid systems, broad surfactants and rifamycin concentration ranges, and generalized mathematical relationships and generalized relationships of A1 and A2 allegedly governing stable dissolution behavior.
However, the specification provides only limited working examples and limited experimental guidance directed primarily to rifamycin formulations under selected formulation conditions.
The nature of the invention is highly formulation-sensitive and unpredictable. The prior art teaches that rifamycin stability is strongly dependent upon pH, buffer composition, and concentration conditions. For example, Jindal et al. (Pharm Ind 57, No. 5, 1995) teach that rifamycin degradation was studied across multiple pH and buffer systems and expressly states that rifamycin was found to be unstable in highly acidic pH solution and maximum stable at pH 4.0. (See Abstract.) Moreover, Jindal et al. describe evaluation of multiple unbuffered system and buffered systems over different pH conditions and demonstrate that rifamycin degradation behavior changes under different formulations. (See Results Section.) Thus, the prior art demonstrates that rifamycin formulation stability is highly sensitive and unpredictable with respect to formulation parameters directly implicated by the instant claims.
Abelson et al (Review of Ophthalmology, published March 3, 2017) further teach that ophthalmic formulations require careful balancing of formulation excipients because formulation components materially affect drug stability, solubility, permeability, residence time, and tolerability. Specifically, Abelson et al teach that control of pH through the addition of buffers is necessary not only for comfort, but also for drug stability, and solubility and the ophthalmic formulations generally maintain at pH range of 1.75 to 7.40. (See second paragraph of page 2.) Abelson et al. additionally teach surfactants and other excipients materially affect corneal permeability and residence time, and the high surfactant concentrations may introduce toxicity concerns. (See third paragraph of page 2; second paragraph of page 3.) Thus, the prior art demonstrates that ophthalmic formulation behavior is highly dependent on multiple interacting formulation variables, further supporting that substantial experimentation would be required to determine operable formulations throughout the full scope of the claims.
Despite the broad scope of the claims, the specification does not provide sufficient guidance enabling the skilled artisan to determine, without undue experimentation, which combinations of rifamycin species, pH values, surfactant systems, surfactant concentrations, buffer systems, and formulation conditions will satisfy the mathematical relationships in claim 1 and the relation of A1 and A2 in claim 2, and maintain the rifamycin compound “stably dissolved” throughout the full scope of the claims.
With respect to claims 6 and 10-11, the claims broadly encompass topical ophthalmic treatment of numerous posterior ocular disease and conditions including age-related macular degeneration and retinal disorders.
However, Rodrigues et al. (Pharm Res (2018) 35: 245, pages 1-5) teach that topical delivery of therapeutics to the posterior segment of the eye remains the “holy grail” of ocular drug delivery. (See Abstract.) Rodrigues et al further teach that ocular anatomical barriers significantly limit posterior ocular delivery, multiple compounds demonstrating success in rodent models failed clinically, and translation from animal models to humans is highly uncertain and difficult. (See Abstract; Preclinical Evaluation; Animal models and translatability Section at page 2.) Accordingly, the relevant art is unpredictable.
Gil-Martinez et al. (Curr Med Chem. 2020;27(4):583-598) teach that AMD (age-related macular degeneration) treatment remains an evolving and challenging field, and that more clinical trials and safety studies are required in order to achieve an optimal treatment. No effective treatment for treating dry AMD. (See Abstract.) This further supports the unpredictability associated with achieving therapeutic efficacy across the broad scope of the claimed ocular disease treatments.
The state of the art is that the prior art demonstrates that formulation stability and posterior ocular delivery depend on numerous interacting variables including pH, buffer selection, surfactant composition, drug concentration, ocular penetration barriers, and formulation environment. The prior art therefore demonstrates that successful formulation optimization requires careful empirical evaluation and cannot reliably predicated across the broad formulation genera.
The quantity of experimentation required is high. Because the claims encompass numerous interacting formulation variables in an unpredictable art, one skilled in the art would be required to engage in extensive empirical screening and optimization to determine which rifamycin compounds, which pH conditions, which surfactant systems, which rifamycin and surfactant concentrations, which buffer systems, and which formulation conditions satisfy the claimed mathematical relationships and the claimed A1 and A2 relationships and maintain stable dissolution throughout the full scope of the claims. Similar extensive experimentation would be required to determine whether topical ophthalmic administration achieves therapeutic efficacy across the full breadth of the claimed ocular diseases and conditions.
Therefore, the specification fails to enable the full scope of the claimed invention.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serizawa (US2017/0202850 A1).
Serizawa teaches an ophthalmic composition comprising an effective amount of rifamycin compound selected from the group consisting of rifampicin, rifabutin, rifapentine and rifaximin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier., wherein the pharmaceutically acceptable carrier comprises a tonicity adjusting agent, wherein the tonicity adjusting agent is saline, dextrose, glycerin, aqueous potassium chloride, buffer salts, propylene glycol, or mannitol, and the ophthalmic composition of claim 10 in the form of a topical eye drop. (See claims 9-12.) Moreover, Serizawa teaches the ophthalmic composition is for use in the manufacture of a medicament for treatment of an ocular disease, disorder or condition. 14, wherein the ocular disease, disorder or condition is selected from age related macular degeneration (AMD), ocular neovascularization, retinal ganglion cell injury and brain damage. (See claims 13-14.)
Particular preference is expressly given to the following formulations of the Tables 1, 2, and 3:
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422
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304
636
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146
618
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612
858
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.
Serizawa further expressly teaches rifamycin was completely dissolved at room temperature in the eye drop formulations of Example 1A and Examples 5A-8A in Tables 1 and 2, and in Examples 11A and 12A for weeks. Additionally, rifamycin was also completely dissolved at refrigerated temperature in the eye drop formulation of Examples 13A -16A for more than several weeks. (See paragraphs [0087] to [0089].)
The instant specification refers to nonionic surfactant to include Tween 80 and benzalkonium chloride (see specification at paragraph [0061]. The ionic surfactant disclosed in the specification at paragraph [0071] encompasses benzalkonium chloride.
Serizawa Tables 1-3 expressly disclose ophthalmic rifamycin formulations containing Tween 80 at 0.5%, which is considered by weight because paragraph [0062] of Serizawa teaches wt%, corresponds to the claimed nonionic surfactant concentration range of 0.00001% to 50% by weight and benzalkonium chloride at 0.01%.
Under one reasonable interpretation, benzalkonium chloride functions as a preservative component in the disclosed formulations. (See instant specification at paragraph [0071].) Under such interpretation, the Serizawa formulations satisfy claim condition (iv), which recite formulation comprising 0.00005% or less ionic surfactant or formulations not comprising such ionic surfactant as the benzalkonium chloride is a preservative, rendering the formulations of Serizawa free of ionic surfactant.
Alternatively, Applicant’s own specification identifies benzalkonium chloride as an ionic surfactant. (See specification at paragraph [0061].) Under Applicant’s own characterization, the Serizawa formulations comprise greater than 0.00005% ionic surfactant and therefore satisfies (ii) of claim 1.
The mathematical expression of previously disclosed concentration relationships does not render the claimed compositions patentably distinct from the prior art compositions expressly disclosed by Serizawa.
With respect to claim 2, Serizawa teaches formulations on Table 2 comprising 0.5% by weight rifamycin, 0.5% by weight Tween 80 (nonionic surfactant), 0.01% by weight benzalkonium chloride (an ionic surfactant according to the instant spec.), and pH 8.5 to 8.7, satisfying (A2) of claim 2.
Accordingly, Serizawa teaches each and every limitation of claims 1-11 and therefore, anticipates the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,850,213 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The U.S. patent claims teach a method of treating an ocular disease, disorder or condition which results from ocular neovascularization comprising topically administering to a patient in need thereof a stable ophthalmic composition comprising about 0.01 wt % to 10 wt % of a solubilized rifamycin compound selected from rifampicin, rifabutin, rifapentine, rifaximin, or a pharmaceutically acceptable salt thereof, about 0.1 wt % to 50 wt % of a non-ionic surfactant, and a pH of about 2 to 12, wherein the composition does not comprise 0.1 wt % rifampicin in combination with 2 wt % polysorbate 80 (Tween 80) wherein the pH is buffered with a citrate, a phosphate, a bicarbonate, a sodium salt, potassium, acetic acid, citric acid, lactic acid, phosphoric acid, hydrochloric acid, sodium hydroxide, sodium phosphate, sodium citrate, sodium acetate, sodium lactate, citrate/dextrose, sodium bicarbonate, ammonium chloride, or a combination thereof, wherein the composition is stable for at least one day, and wherein the ocular neovascularization comprises retinal or choroidal neovascularization. (See claims 1 and 2.) The U.S. patent claims further teach the composition is a topical eye drop and further comprising a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises a tonicity adjusting agent, wherein the tonicity adjusting agent is selected from the group consisting of saline, dextrose, glycerin, aqueous potassium chloride, buffer salts, propylene glycol, and mannitol. (See claims 12-14.
The fact that the U.S. patent claim does not recite ionic surfactant and buffer solution other than boric acid buffer, the composition taught by the U.S. patent claim satisfies (iii) and (A2) of claims 1 and2.
The mathematical expression of previously disclosed concentration relationships does not render the claimed compositions patentably distinct from the prior art compositions expressly disclosed by Serizawa.
Conclusion
Claims 1-11 are not allowed.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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