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 .
CONTINUING DATA
This application is a 371 of PCT/AU2023/050103 02/15/2023
FOREIGN APPLICATIONS
AUSTRALIA 2022900318 02/15/2022
Claims 1-21 are pending.
Claim Objections
Macular edema is misspelled in claim 12.
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 7, 9, 13-14, 16, 18, 20-21 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 7 recites that the glucocorticoid “may comprise” a list of compounds. The use of the word “may” calls into question whether the recited compounds are actually required or are optional.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 9 recites the broad recitation “fludrocortisone,” and the claim also recites “optionally” “one or mor of fludrocortisone acetate and fludrocortisone acetonide,” which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation “back of eye disease or condition,” and the claim also recites “optionally” “eye disease or condition involving the retina, macular and/or fovea in the posterior region of the eye.”
Claim 14 recites the broad recitation “dry AMD,” and the claim also recites “optionally early AMD and geographic atrophy (GA),” which is the narrower statement of the range/limitation.
Claim 16 recites the broad recitation “0.01 wt% to about 10 wt%,” and the claim also recites “optionally about 0.025 wt% to about 2.5 wt%,” which is the narrower statement of the range/limitation.
Claim 18 recites the broad recitation “pre-filled syringe,” and the claim also recites “optionally the pre-filled syringe comprises two barrels,” which is the narrower statement of the limitation.
Claim 20 recites the broad recitation “carrier,” and the claim also recites “optionally the carrier comprises hemp oil comprising about 80% to 90% balanced Omega fatty acids,” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 21 recites that the hemp or hemp oil “is for use or when used as a carrier or delivery vehicle for the one or more steroids.” The meaning of this limitation is unclear. The recitation of “when used” implies a conditional limitation, but the claim does not recite what is required when the hemp oil is used as a carrier.
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.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue' , not ‘experimentation' ” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
Claim 2 is 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 the use of a steroid, does not reasonably provide enablement for use of any compound capable of modulating an activity of a steroid receptor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claims are drawn to a method of treating a retinal eye condition using a compound capable of modulating an activity of a steroid receptor.
The specification does not provide any limiting definition or guidance regarding the compound capable of modulating an activity of a steroid receptor, so the claims are interpreted to encompass the use of any such compound.
Kumar (Endocr Rev. 2012 Mar 20;33(2):271–299) teaches that steroid hormones include progestins, corticosteroids, androgens, and estrogens. Page 272.
Buijsman (Current Medicinal Chemistry, 2005, 12, 1017-1075) teaches that non-steroidal ligands for steroidal nuclear receptors exist. See abstract. Compounds include tetrahydropyridazines (page 1017), tetrahydronaphthofuranones or tetrahydrobenzindolones (page 1020), 2-HYDROXY-3-[1-(3-TRIFLUOROMETHYL PHENYL)CYCLOPROPYL] PROPIONYLAMIDO (page 1022), benzimidazole-2-thiones (page 1023), 2,3,4,14B-TETRAHYDRO-1H-DIBENZO[b,f]PYRIDO [1,2-d][1,4] OXAZEPIN-1-AMINES (page 1024), dihydroquinolines (page 1025), bicyclo[2.2.2]octanes (page 1027), triphenyl(cyclo)propyl(sulfon)amides and triphenylmethanes (page 1029), 1H-benzo[F]indazoles (page 1031), octahydro-2H-naphto-[1,2-F]-indazoles (page 1032), and many more. Buijsman illustrates that each of these classes are characterized by different chemical structures, and even within a given class differences in activity occur. See the Tables under each chemical class in Buijsman. Thus, a great many compounds of widely differing chemical structures fall within the scope of claim 2.
The current specification provides evidence that not every compound which modulates the activity of a steroid receptor would be effective in the claimed invention. Paragraph [0088] states that RU486 was found to completely abrogate the FA-mediated suppression of Ccl2, Il-6, and Il-8 following IL-b simulation (P<0.05). However, incubation with RU28318, a mineralocorticoid receptor antagonist (B), did not significantly alter the expression of Cc12, Il-6, and Il-8.
Considering the state of the art as discussed by the references above, particularly with regards to the large number of compounds encompassed by the method of claim 2 and the high unpredictability in the art as evidenced by the current specification, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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) 1-2, 4-5, 7-8, 10-13, 15, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong (Japanese Journal of Ophthalmology (2020), vol. 64, pages 196-202, cited on IDS).
Hong teaches treated of diabetic macular edema refractory to VEGF therapy using intravitreal triamcinolone acetonide. IVTA is an alternative steroid treatment for DME refractory to anti-VEGF therapy. The injection solution comprised a preservative.
Claim(s) 1-4, 7, 11-13, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barikian (Retina 37(7): p 1337-1344, July 2017, abstract only).
Barikian teaches the administration of intravitreal dexamethasone followed by intravitreal ranibizumab for treatment of age-related macular degeneration resistant to bevacizumab and ranibizumab. Barikian does not explicitly state that an excipient or carrier was used, but because the steroid was in the form of an implant, an excipient or carrier was necessarily present.
Claim(s) 1-4, 7, 11-13, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallsh (Cells 2021, 10, 1049).
Wallsh teaches that anti-VEGF therapy is used for exudative age-related macular degeneration and diabetic retinopathy. A subset of 15-40% of eyes fail to respond or only partially respond. For these cases, steroid injections are employed. See abstract. Intravitreal triamcinolone acetonide combined with IVB and intravitreal dexamethasone implants have been employed. IVTA and DEX have been used for treatment of anti-VEGF-resistant DME. Page 9, Section 4.1. Intravitreal fluocinolone acetonide has been used to treat anti-VEGF-resistant DME and works best when supplemented with continued intravitreal anti-VEGF injections (page 10, Section 4.1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claim(s) 6, 9, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallsh (Cells 2021, 10, 1049) in view of Karmel (Anti-VEGF Treatment and Dry AMD: Finding the Balance, EyeNet Magazine, Clincal Update, May 1, 2013) and Penfold (WO 2019/161434 A1, August 29, 2019)
Wallsh teaches that anti-VEGF therapy is used for exudative age-related macular degeneration and diabetic retinopathy. A subset of 15-40% of eyes fail to respond or only partially respond. For these cases, steroid injections are employed. See abstract. Wallsh suggests that triple therapy (PDT, intravitreal anti-VEGF and intravitreal steroids) may offer an additional benefit. Page 6, first paragraph. In the case of anti-VEGF-resistant eAMD, an inflammatory component is partially to blame for resistance.
Wallsh does not teach that dry AMD is treated. Wallsh does not teach that fludrocortisone is used for treatment.
Karmel teaches that anti-VEGF treatment may accelerate dry AMD. Page 39, second column.
Penfold teaches a method of treating dry AMD by administering an anti-inflammatory agent such as fludrocortisone. See abstract. Additional steroids which may be used are recited in paragraphs [0025]-[0028].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer fluocinolone acetate to treat dry AMD in a subject which had been treated with an anti-VEGF agent because anti-VEGF agents exacerbate dry AMD and dry AMD may be treated with steroids. It would have been further obvious to treat using fludrocortisone because Penfold teaches that fludrocortisone is a preferred compound for treating dry AMD.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallsh or Hong in view of Gallemore (EyeNet Magazine, October 1, 2004, Intravitreal Kenalog Injections).
Wallsh and Hong teach injection of triamcinolone acetate as set forth above but are silent about the concentration.
Gallemore teaches that triamcinolone acetate is used to treat retinal diseases such as macular edema, and the concentration is 40 milligrams per milliliter. See page 1.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the process taught by Wallsh or Hong wherein the concentration of TA was 4% because a commercial TA product used for the same purpose has a concentration of 4%.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallsh or Hong in view of Cornelius (US4212863, 1980) and Penfold (WO 2019/191800 A1, October 10, 2019).
Wallsh and Hong teach injection of triamcinolone acetate as set forth above but do not teach that hemp oil is used as a carrier.
Cornelius teaches that injection preparations of steroids are known and usually consist of solutions of the steroid in oily carriers, such as sesame oil, olive oil, and similar carriers. See column 1, second paragraph.
Penfold teaches that hemp oil can be used to treat AMD. See abstract. The hemp oil may comprise 80-90% balanced omega fatty acids [0023]. The hemp seed oil may also function as a carrier [0036] for a steroid such as triamcinolone [0039].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out Wallsh’s or Hong’s treatment method wherein a carrier comprises hemp oil. Injection preparations of steroids usually include oily carriers. Hemp oil can be used as a carrier and has the added benefit of treating AMD, as taught by Penfold. Hemp oil is also taught to be effective as a carrier for steroids, as taught by Penfold. The skilled artisan would have employed hemp oil along with Wallsh’s or Hong’s steroid in order to both treat disease and to act as a carrier.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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