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 .
Detailed Action
This application is a national stage application of PCT/KR2020/017918, filed December 9, 2020, which claims benefit of foreign application KR10-2019-0177010, filed December 27, 2019. Claims 1-10 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted September 26, 2023 is acknowledged wherein claim 6 is amended and new claims 7-10 are introduced.
Claim Interpretation
Claims 2, 6, and 8 all refer to aucubin being present at a concentration of 1-500 mg/kg. For claims 2 and 6, these claims are directed to a pharmaceutical composition and therefore are interpreted as if “kg” referred to kilograms of the pharmaceutical composition. Claim 8 claims a method of treating a subject. Therefore in this claim the range can be interpreted as either referring to mg of aucubin per kg of composition or mg of aucubin per kg of subject body weight, and is considered to be infringed by either value.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. Independent claim 1 recites a pharmaceutical composition for the prevention or treatment of macular degeneration comprising aucubin, which is a natural product present in the leaves and stems of Aucuba japonica, for example. (See for example Kang et al., included with PTO-892, which describes extraction of aucubin as a natural product) This judicial exception is not integrated into a practical application because while the preamble to claim 1 describes an intended use for treating or preventing macular degeneration, as discussed in MPEP 2106.04(d)(2), the recitation of an intended use for a judicial exception without the recitation of any affirmative steps to carry out said intended use does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while the claim describes the invention as a “pharmaceutical composition” this is an extremely generic limitation that could encompass any composition and does not require the addition of any particular element that would amount to significantly more than the judicial exception.
Regarding claims 2 and 6, these claims require that the aucubin is present in a specific concentration in the composition at a particular concentration. However, there is no evidence that aucubin present in this form has markedly different characteristics than naturally occurring aucubin.
Regarding claims 3 and 5, these claims specify that the pharmaceutical composition is in a particular physical form, such as a solution, suspension, health food, or the like. Claim 4 requires that the composition be suitable for particular modes of administration. However, these claims are extremely generic and fail to describe additional elements with enough specificity to provide significantly more than the natural product or to integrate it into a judicial exception.
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.
Claim 8 is 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 8 claims a method of treating a subject with the active agent aucubin, wherein the aucubin is present at a concentration of 1-500 mg/kg. This claim does not specify whether the kg in “mg/kg” refers to the mass of the pharmaceutical composition or to the subject’s body weight. Therefore it is impossible for one skilled in the art to accurately determine the appropriate amount of active agent, rendering the claim indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al. (Reference included with PTO-892)
Independent claim 1 is directed to a pharmaceutical composition comprising the compound aucubin. While the claim refers to an intended use for treating or preventing macular degeneration, this recitation of an intended use does not serve to apply any meaningful further limitation to the pharmaceutical composition beyond the presence of the compound itself. Kang et al. discloses extraction of Aucuba japonica with ethanol, and determination of the presence of aucubin in said extract. (p. 2 section 2.1, p. 7 section 4.1) Aucubin was then prepared as solutions of various concentrations of 1-100 µg/mL (equivalent to 1-100 mg per kg of solvent) for cell culture experiments (p. 7 section 4.2) or prepared as a solution for ocular administration at concentrations of 75, 100, or 250 mg/kg to experimental animals. (p. 8 paragraph 4.5) Any of these compositions described by Kang et al. are reasonably considered to be pharmaceutical compositions comprising aucubin and falling within the scope of independent claim 1, as well as dependent claim 2, which merely recites a concentration range encompassing the amounts described by Kang et al.
Regarding claims 3 and 4, the compositions prepared by Kang are seen at the very least to be solutions and suitable for topical (e.g. ocular) administration. Regarding claims 5 and 6, these claims include a preamble describing the composition as a “health functional food.” However the claims do not further describe what a health functional food actually is or what sort of structural features of the composition would be necessary to infringe this limitation. Still further, p. 7 of the present specification, which describes “heath functional foods,” does not provide a limiting definition that would exclude, for example, a solution that could theoretically be consumed orally. Furthermore note that claims 5-6 are directed to a composition and do not require actively performing any process steps such as orally administering the composition to a subject. Therefore the solutions produced by Kang still fall within the broadest reasonable interpretation of “health functional food,” and anticipate the present claims.
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.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. as applied to claims 1-6 above, and further in view of Theodossiadis et al. (Reference included with PTO-892)
The disclosure of Kang et al. is discussed above. Kang et al. does not disclose a method of treating a subject suffering from age-related macular degeneration (AMD). However, Kang et al. does disclose that aucubin has the effect of reducing expression of inflammatory cytokines in corneal epithelial cells, including TNF-α. (p. 3 section 2.4, p. 4 figure 4)
Theodossiadis et al. discloses that tumor necrosis factor (TNF) is involved in the pathogenesis of AMD, and an agent that interferes with TNF signaling would be a promising therapeutic agent. (p. 825 fight column first and second paragraphs) Theodossiadis et al. further discloses intravitreal administration of the anti-TNF antibody infliximab to patients having neovascular AMD. (cases 1-3, pp. 826-828) This treatment improved visual acuity and reduced central foveal thickness in all three patients.
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the tubacin-containing eyedrops described by Theodossiadis et al. to a patient suffering from neovascular AMD. One of ordinary skill in the art would have found this to be obvious based on the disclosure by Theodossiadis et al. that targeting TNF-alpha is effective at treating this condition, suggesting that ocular administration of an agent that reduces TNF expression would also be useful.
Therefore the invention taken as a whole is prima facie obvious.
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 and 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 11938162. (Cited in PTO-892, herein referred to as ‘162) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘162 anticipate the present claims.
Specifically, claim 1 of ‘162 claims a process comprising administering an herbal extract comprising aucubin to a subject for treating dry eye. This herbal extract is therefore reasonably considered to be a pharmaceutical composition comprising aucubin according to present claim 1. Regarding present claims 3 and 4, claim 2 of ‘162 describe the extract as being produced by extraction with ethanol or hot water. Both of these solvents are pharmaceutically acceptable excipients, and the process of making the extract would necessarily have involved a solution of aucubin in these solutions, which would be a solution according to claims 3 and 4. Regarding present claim 5, claim 5 of ‘162 claims a method wherein the extract is administered orally. An orally administered composition is reasonably considered to be a functional food according to present claim 5, anticipating this claim.
Claims 2 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 11938162 as cited above in view of Kang et al. (Reference included with PTO-892)
Claims 1, 2, and 5 of ‘162 are discussed above. While the claims of ‘162 do not specifically describe the concentration of aucubin in the extract, Kang et al. as discussed previously under 35 USC 103 discloses the administration of therapeutic compositions having concentrations of aucubin falling within the claimed ranges. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to prepare aucubin therapeutic compositions in the claimed concentrations, in view of the suggesting by Kang et al. that this is a useful concentration to use for the therapy of dry eye.
Claims 1, 3-5, 7, 9, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-7 of copending Application No. 18/936180 (reference application, US pre-grant publication 2025/0057904, cited in PTO-892, herein referred to as ‘180) as evidenced by Kang et al. (Reference included with PTO-892) Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 7 claim a method of treating macular degeneration using a composition that inherently comprises aucubin. Specifically, Kang et al. discloses producing an extract of the leaves and stems of Aucuba japonica using 30% ethanol. (p. 7 section 4.1) This extract contained aucubin. (p. 2 section 2.1) Similarly, dependent claims 3-5 of ‘180 describe the extract used in the claimed method as having been produced in the same manner, using the same botanical starting material and extraction solvent. Therefore the extract used would inherently contain aucubin, and thereby anticipate the composition of claim 1 and the method of claim 7. Still further an extract produced by a liquid solvent from a plant material would be a solution as recited in present claims 3, 4, and 9. Finally, claim 7 of ’180 claims a method wherein the composition is a functional health food composition, thereby anticipating claim 5, as well as inherently requiring oral administration as recited in present claim 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 2/5/2026