DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11 are currently pending in the application and under examination. An action on the merits follows. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2023/010178, filed 15 March 2023, which claims priority to JAPAN 2022-041536, filed 16 March 2022. Filing of a certified untranslated copy of the JAPAN 2022-041536, filed 16 March 2022, is acknowledged. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 16 March 2022.
Information Disclosure Statement
The information disclosure statements filed 26 November 2024 and 24 March 2026 have been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: the Brief Description of the Drawings does not include a description of each panel. Specifically, the descriptions of Figure 3, 4, and 5 do not include individual descriptions of panels 3A-B, 4A-B, and 5A-D. See MPEP 608.01(f), which states, “When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures, and to the different parts by use of reference letters or numerals”. Further, MPEP 608.01(f) instructs Examiners such that “If the drawings show Figures 1A, 1B, and 1C and the brief description of the refers only to Figure 1, the examiner should object to the brief description, and require applicant to provide a brief description of Figures 1A, 1B, and 1C.” Appropriate correction is required.
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 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. Claims 2-5, 7, and 9-11 are included in this rejection due to their dependence on and/or incorporation of independent claim 1.
Claim 1 recites, “a viscosity” in line 4, which is indefinite because it is unclear what solution has the viscosity recited. For example, it is unclear whether “a viscosity” is referring to the viscosity of the transplantation medium, the hyaluronic acid, or the pharmaceutically acceptable aqueous liquid. As such, the metes and bounds of the claim cannot be determined.
Claim 6 recites, “which is free of an antibacterial agent and a preservative”, which is indefinite because it is unclear whether the transplantation medium must be free of an antibacterial agent and free of a preservative or whether the transplantation medium must merely be free of having both an antibacterial agent and a preservative, such that having either an antibacterial agent or a preservative would satisfy the claim. As such, the metes and bounds of the claim cannot be determined.
Claim 8 recites, “wherein in the transplantation, the vitreous body is replaced with air after subretinal transplantation”, which is indefinite because it is unclear whether claim 8 is directed towards the composition of claim 1 or to a method of using the composition of claim 1. Claim 8 indicates that the method step recited is a step which would follow transplantation, wherein transplantation is the intended use of the transplantation medium of claim 1. Accordingly, claim 8 recites a method step which is a step that would follow a step of using the composition of claim 1, but does not recite any limitations which further limit the structure of the claimed transplantation medium per se. As such, the metes and bounds of the claim cannot be determined.
In the interest of compact prosecution, claim 8 has been interpreted to recite an intended use of the transplantation medium of claim 1 which adds structure to the invention only to the extent that the structure is required for the function and not merely desirable for the intended function.
Claim Rejections - 35 USC § 112(a)- Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 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.
The claims read broadly on a transplantation medium comprising hyaluronic acid (HA) and a pharmaceutically acceptable aqueous liquid, wherein a viscosity at a shear rate of 2 s-1 at 25 oC is 1.5-4 mPa*s without reciting a concentration range nor an average molecular weight (MW) range for the hyaluronic acid within the medium which would achieve the recited viscosity values. The hyaluronic acid-comprising medium is defined functionally by a single viscosity value range and not by the structure of the fluid itself. As such, the claims read broadly on any fluid comprising hyaluronic acid and a pharmaceutically acceptable aqueous liquid which have combined average HA MWs and HA concentrations so as to exhibit the inherent functions of viscosity at a shear rate of 2 s-1 at 25 oC is 1.5-4 mPa*s.
The specification generically teaches ranges of average MWs for HA of 500,000 to 3.9 million (preferably 1.5 million to 3.9 million) [0066, 0111] and concentrations of HA of 0.005 w/v% to 0.15 w/v% (e.g., 0.007 w/v% to 0.04 w/v%, 0.008 w/v% to 0.035 w/v%, 0.009 w/v% to 0.03 w/v%, approximately 0.01 w/v%) [0066]. The specification also teaches that a commercially available aqueous solution of hyaluronic acid or a salt thereof can be used, including commercial preparations such as VISCOAT® 0.5, PROVISC® 0.85, OPEGAN® 0.6, OPEGAN® 1.1, and Hyelein® Mini, along with their corresponding HA concentrations of 3%, 1%, 0.6%, 1.1%, and 0.3%, respectively [0053].
However, the specification specifically teaches viscosity values for only 1:20, 1:100, and 1:200 dilutions of each of VISCOAT® and PROVISC® formulations, wherein only the 1:100 dilutions of each exhibit viscosity values of 1.5-4 mPA*s at a shear rate of 2 s-1 at 25 oC [Table 4, 5]. The specification teaches HA concentrations for the VISCOAT® and PROVISC® formulations but does not teach the average HA molecular weights of each solution. Accordingly, the disclosure teaches that the full range of concentrations and average molecular weights generically taught does not provide the claimed functional viscosity properties.
The specification fails to provide any specific guidance as to the range of average MW-concentration combinations which would exhibit the claimed viscosity values of 1.5-4 mPA*s at a shear rate of 2 s-1 at 25 oC encompassed by the claims. The specification also fails to provide any guidance for an expected relationship among HA average MW, HA concentration, viscosity, and shear rates which would allow an ordinarily skilled artisan at the time of filing the instant application to immediately envisage the range of attribute combinations for solutions which would exhibit the claimed functional viscosity values.
Thus, of the large genus of HA average molecular weight and concentration combinations, the specification only discloses 6 combinations, wherein only 2 of the 6 disclosed combinations exhibit the claimed function. However, this description is not sufficient to adequately describe and demonstrate possession of the full scope of the claimed invention.
The following guidance provided in MPEP 2163 is informative. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. In other words, describing a composition by its function alone typically will not suffice to sufficiently describe the composition. See for example Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described."). Furthermore, written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996). While it has been held that what is conventional or well known to one of ordinary skill in the art need not be disclosed in detail, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
The specification, as described above, provides generic guidance for average molecular weights and concentrations of HA without providing guidance as to the ranges of average MWs and concentrations which would exhibit the claimed viscosity values. Therefore, the specification provides generic guidance for the instant claimed products without providing sufficient detailed descriptions of the genus of hyaluronic acid solutions which exhibit the claimed viscosity. At best, the working examples of the specification disclose only two HA solutions having the claimed viscosity, the 1:100 diluted VISCOAT® and PROVISC® formulations, but fail to provide any indication of the HA MW of each of these solutions nor the ranges of concentration and MW which would exhibit the claimed viscosity beyond four additional examples which do not exhibit the claimed viscosity values.
As such, the specification fails to provide a description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of any of the claimed genus of media comprising hyaluronic acid and having viscosity values of 1.5-4 mPA*s at a shear rate of 2 s-1 at 25 oC.
It is also noted that at the time of filing, it was well known that varying the concentration and/or the average molecular weight of an HA-comprising fluid will alter the shear rate-dependent viscosity of the fluid, wherein altering HA concentration or altering molecular weight will each independently alter the viscosity of the solution in a non-linear relationship [Kim et al. 2018, Archives of Oral Biology, 89, 55-64, Figure 1, 2]. Thus, it is clear that at the time of filing, the scope of hyaluronic acid solutions of various average molecular weights and concentrations which would exhibit a specific viscosity value at a specific shear rate and a temperature was not considered well-developed or predictable. As such, the full genus of HA solutions having viscosity values of 1.5-4 mPA*s at a shear rate of 2 s-1 at 25 oC was neither conventional nor predictable at the time of filing, and the knowledge and level of skill in the art at the time of filing would not have permitted the ordinary artisan to immediately envisage the claimed HA-comprising media products from the generic description provided by the specification. In view of these considerations, a skilled artisan would not have viewed the teachings of the specification as sufficient to show that the Applicant was in possession 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gay [US20190030168A1, IDS], as evidenced by Alcon [2014, DuoVisc Viscoelastic System, retrieved on 08 September 2026 from: www.medline.com/media/catalog/Docs/MKT/DUOVISC_.PDF, 1-4].
Gay discloses a clinical media/transplantation media for administering RPE cells to a subject in need thereof [abstract, 0029, 0031, 0044], wherein the media comprises hyaluronic acid and a pharmaceutically acceptable aqueous liquid [0020]. Gay further teaches wherein the solution comprises 0.01% w/v HA and wherein the HA is PROVISC® (Alcon) [0020].
Gay also teaches the use of a viscoelastic polymer at a concentration providing a viscosity of the solutions or preparation provided that corresponds to the viscosity of the same solution or preparation comprising 0.01-0.05% HA [0079].
Gay does not explicitly teach wherein the viscosity values at a shear rate of 2 s-1 at 25 oC is 1.5-4 mPA*s. Note, however, that viscosity at a particular shear rate and a particular temperature is an inherent property of a solution. Additionally, the instant claims are interpreted in light of the instant specification. The instant specification teaches that 1:100 dilutions of PROVISC® 0.85 ophthalmic viscoelastic substance 1% (Alcon) having 0.01% w/v HA exhibits a viscosity at a shear rate of 2 s-1 at 25 oC of 2.13 mPA*s, as well as viscosities of 3.13, 1.89, and 1.25 at 1, 10, and 1000 s-1 at 25 oC, respectively [Table 4, 5]. Therefore, any solution comprising a 0.01% dilution of PROVISC® HA solution will inherently possess the property of a viscosity at a shear rate of 2 s-1 at 25 oC of 2.13 mPA*s. “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent.” See MPEP 2112.01 or In re Best, 195 USPQ 430, 433 (CCPA 1997). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Therefore, by teaching wherein the solution comprises 0.01% w/v HA and wherein the HA is PROVISC® (Alcon) [0020], Gay is teaching a solution which inherently exhibits a viscosity at a shear rate of 2 s-1 at 25 oC of 2.13 mPA*s.
Regarding claims 2-3, note that the viscosities at other shear rates are similarly inherent properties of the claimed solution. Accordingly, the solution media taught by Gay comprising 0.01% w/v PROVISC® HA will likewise have the same inherent viscosities at 1, 2, 10, and 1000 s-1 at 25 oC as taught for the 1:100 dilution of PROVISC® in the instant specification Tables 4 and 5.
Regarding claim 4, Gay discloses wherein the pH of the solution is 7.4-7.5 [0016].
Regarding claim 5, Gay discloses wherein the HA is mixed with a balanced salt solution [0268, 0278].
Regarding claims 6-7, Gay discloses preparation of the clinical media without the addition of an antibacterial agent, a preservative, nor chondroitin sulfate, and so the clinical media of Gay is presumed to be free of antibacterial agents, preservatives, and chondroitin sulfate, absent evidence to the contrary [0266-0278]. Additionally, Alcon teaches wherein PROVISC® itself does not comprise any antibacterial agents, preservatives, nor chondroitin sulfate [page 1 ¶ 10].
Regarding claim 8, note that “wherein in the transplantation, the vitreous body is replaced with air after subretinal transplantation” has been interpreted to recite an intended use of the transplantation media according to claim 1 which adds structure to the invention only to the extent that the structure is required for the function and not merely desirable for the intended function. Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure (e.g., clinical media) is capable of performing the intended use (e.g., subretinal transplantation), then it meets the claim limitations. It is a general rule that merely discovering and claiming a new benefit to an old process cannot render the process again patentable. In re Woodruff, 919 F. 2d 1575, 1577-78, 16 USPQ2d 1934, 1936-37 (Fed.Cir. 1990); In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 229 (CCPA 1971); and Ex Parte Novitski, 26 USPQ2d 1389, 1391 (Bd. Pat. App. & Int. 1993).
Further, replacement of the vitreous body with air following subretinal transplantation of cells in the transplantation media is a method step which does not further limit the structure of the transplantation media used in the subretinal transplantation. Accordingly, claim 8 has been afforded its broadest reasonable interpretation such that the transplantation media merely needs to be capable of being transplanted subretinally to meet the limitations of claim 8. The intended use as claimed does not add further structural limitations to the transplantation medium as claimed in claim 1, and as such, the teachings in the prior art of a clinical/transplantation medium which meets the limitations of claim 1 necessarily meets the intended use limitations of claims 8.
Gay teaches sub-retinal injections/transplantations of RPE cells comprised within the clinical/transplantation media [0368, 0379, Example 12 Table 1], thereby teaching that the medium may be transplanted subretinally.
Regarding claim 9, note that “for transplantation” in line 2 represents an intended use which adds structure to the invention only to the extent that the structure is required for the function and not merely desirable for the intended function.
Gay discloses RPE cells for transplantation combined with the clinical/transplantation medium [0371].
Regarding claim 10, Gay discloses transplanting 1 x 105 RPE cells in 2 µl of solution (i.e., 5 x 107 cells/mL) [0089, 0101, Example 12 Table 1].
Regarding claim 11, note that claim 11 recites an intended use of the transplantation composition of claim 9, merely reciting a volume intended to be transplanted, which adds structure to the invention only to the extent that the structure is required for the function and not merely desirable for the intended function. Accordingly, claim 11 has been afforded its broadest reasonable interpretation such that the transplantation media merely needs to be capable of being transplanted with a volume of 10-100 µl to meet the limitation of claim 11. The intended use as claimed does not add further structural limitations to the transplantation medium as claimed in claim 1, and as such, the teachings in the prior art of a clinical/transplantation medium which meet the limitations of claim 1 necessarily meet the intended use limitations of claims 11. Gay discloses subretinally injecting volumes of 2 µl or 150 µl of cells within the clinical/transplant media [0341, 0349]. As such, the transplantation media of Gay is necessarily capable of being transplanted in volumes between 2 and 150 µl, including 10-100 µl.
Accordingly, by teaching all of the limitations of claims 1-11 as written, Gay anticipates the instant invention as claimed.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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