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 .
Status of the Claims
Claims 1, 3-12 and 17-18 are currently pending. Claims 2 and 13-16 are canceled. Claims 1, 6, 8 and 11 are amended. This is the first Office Action on the merits.
Information Disclosure Statement
No Information Disclosure Statement has been filed. Applicant is reminded of their duty to disclose.
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 6-8 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 8 is rejected under 35 USC 112(b) for reciting “undesirably dark skin”.
The phrase “undesirably dark skin” in claim 8 is a relative term which renders the claim indefinite. The phrase “undesirably dark skin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One skilled in the art, therefore, would not be reasonably apprised of the metes and bounds of the claims.
For the purposes of this office action claim 8 will be interpreted to mean dark skin.
Claims 6 recite an improper Markush group “selected from”. See MPEP 2173.05(h). The group is listed using the alternative “or” and it is unclear whether the group is open ended or closed. This ambiguity has rendered the claim indefinite.
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Claim 6 recites an improper Markush group in the recitation of the phrase “selected from” and the use of the alternative conjunction “or” in listing the group. See MPEP 2173.05(h). The use of this language makes it unclear whether the group is open ended or closed. This ambiguity has rendered the claim indefinite.
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Claim 7 recites an improper Markush group in the recitation of the phrase “selected from” and the use of the alternative conjunction “or” in listing the group. See MPEP 2173.05(h). The use of this language makes it unclear whether the group is open ended or closed. This ambiguity has rendered the claim indefinite.
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Claim 8 recites an improper Markush group in the recitation of the phrase “selected from” and the use of the alternative conjunction “or” in listing the group. See MPEP 2173.05(h). The use of this language makes it unclear whether the group is open ended or closed. This ambiguity has rendered the claim indefinite.
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C 102(b)(2)(C) for any potential 35 U.S.C 102(a)(2) prior art against the later invention.
Claims 1, 5-12 and 17-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Farwick et al. US 2010/0311668 (10/22/2009) in view of Sun et al. Bisacurone Inhibits Adhesion of Inflammatory Monocytes or Cancer Cells to Endothelial Cells Through Down-Regulation of VCAM-1 Expression, International Immunopharmacology 8, 1272-1281 (2008) and Megumi et al. Preventive Activity of ar-Turmerone and Bisacurone Isolated From Turmeric Extract Against Ethanol Induced Hepatocyte Injury, Food Science and Technology Research, 23 (2), 175-281, 2017 as evidenced by Mae et al. US 2004/0028751 (2/12/2004).
Farwick et al. (Farwick) teaches a method of reducing the visible signs of aging in human skin and hair that comprises applying to skin in need of such treatment a topical composition comprising a safe and effective amount of a tetrapeptide and a safe and effective amount of at least one additional active ingredient that includes a skin lightening agent, an anti-inflammatory active and a dermatologically acceptable carrier. (See Abstract and Farwick claim 9). Farwick teaches kojic acid as a skin lightening agent. (See [0039]). Kojic acid is called for in instant claim 7. Farwick also teaches that the topical composition can comprise ascorbic acid (called for in instant claim 11) which is a skin rejuvenation agent as called for in instant claim 10. Topical application is called for in instant claim 5. With respect to the method of whitening the skin in claim 1, kojic acid will lighten skin since Farwick teaches that it is a known skin lightening agent. (See [0039]).
Farwick teaches that the skin that is treated may be undesirably dark skin such as dark circles. (See [0108]). Undesirably dark skin is called for in instant claim 8. A human patient is called for in instant claim 9. The composition may be a solution as called for in instant claim 6.
Farwick also teaches that the topical composition can also comprise turmeric extract. (See [0070]). Turmeric extract is turmeric rhizome extract as called for in instant claim 12 as evidenced by Mae et al. which teaches at [0038] that turmeric is the raw material of the turmeric extract and it is the root or the rhizome of Curcuma longa. (See Mae [0038]).
Farwick does not teach an effective amount of bisacurone or bisacurone that is extracted from a turmeric rhizome. These deficiencies are made up for in the teachings of Sun et al. and Megumi et al.
Sun et al. (Sun) teaches that bisacurone, one of the active compounds of the traditionally used indigenous herb Curcuma longa, has anti-oxidant, anti-inflammatory and anti-metastatic activities. (See Abstract). Sun teaches an isolated and purified bisacurone. (See page 1273). The amount of isolated and purified bisacurone is 220 mg which is an effective amount as called for in instant claim 1. It is an effective amount because concentrations of bisacurone that are much less (specifically 1, 5, 10 and 50 microMolar concentrations, see Sec. 3.1) were effective in inhibiting VCAM-1 luc promoter activity dose dependently. (See Sec. 3.1 and Figure 2). An effective amount of bisacurone is called for in instant claim 1.
Sun teaches that the bisacurone is obtained through solvent extraction, specifically using methanol solvent. (See Section 2.1 Extraction and isolation). Sun thus teaches that the bisacurone is obtained by solvent extraction as called for in instant claim 17. Methanol extraction is also alcohol extraction as called for in instant claim 18.
Megumi et al. (Megumi) describes a study using bisacurone extracted from a turmeric rhizome. (See Abstract, page 276 and 279). The study describes the demonstrable cytoprotective activities of isolated bisacurone against ethanol-induced hepatocyte injury. (See Figure 5). Cells were treated with purified bisacurone and then exposed to 1.5% ethanol for 24 hours. (See Figure 5). A biscurone that is an extract of a turmeric rhizome is called for in instant claim 12.
It would be prima facie obvious to one of ordinary skill in the art before the earliest effective filing date following the Farwick method to use 220 mg purified bisacurone to the composition as an additional anti-inflammatory in order to give the composition anti-oxidant and anti-inflammatory activities as taught by Sun. There would be a reasonable expectation of success because Farwick teaches the acceptability of the inclusion of additional antioxidants from botanical sources.
It would be prima facie obvious to one of ordinary skill in the art before the earliest effective filing date following the Farwick method to use methanol solvent extraction of turmeric to obtain bisacurone as taught by Sun in order to have a simple alcohol solvent extraction method that is effective at obtaining bisacurone as taught by Sun.
It would be prima facie obvious to one of ordinary skill in the art before the earliest effective filing date following the Farwick method to use obtain bisacurone from turmeric rhizome as taught by Megumi in order to have a bisacurone that is able to protect cells from ethanol damage as taught by Megumi.
Claims 3-4 are rejected under 35 U.S.C. 103(a) as being unpatentable over Farwick et al. US 2010/0311668 (10/22/2009) in view of Sun et al. Bisacurone Inhibits Adhesion of Inflammatory Monocytes or Cancer Cells to Endothelial Cells Through Down-Regulation of VCAM-1 Expression, International Immunopharmacology 8, 1272-1281 (2008) and Megumi et al. Preventive Activity of ar-Turmerone and Bisacurone Isolated From Turmeric Extract Against Ethanol Induced Hepatocyte Injury, Food Science and Technology Research, 23 (2), 175-281, 2017 as evidenced by Mae et al. US 2004/0028751 (2/12/2004) as applied to claims 1, 5-12 and 17-18 and further in view of KR 20180121412 (11/7/2018)(“KR”).
The teachings of Farwick in view of Sun and Megumi are described supra. Farwick in view of Sun and Megumi do not teach oral or systemic administration. These deficiencies are made up with the teachings of KR.
KR teaches a whitening cosmetic composition and beauty functional food containing demothoxycurcumin isolated from a Curcuma aromatic extract which has melanin synthesis inhibitor activity. (See Abstract). While KR does not teach bisacurone, it does teach that extracts of Curcuma can be administered topically, orally and systemically and can aid in whitening skin or inhibiting melanin synthesis. In addition to demethoxycurcumin, the cosmetic composition may contain conventional adjuvants and carriers such as antioxidants. (See pages 9 and 12). Thus, the inclusion of additional antioxidants is expressly taught.
KR teaches that oral administration is preferred. (See page 12). Oral administration is called for in instant claim 3 and systemic administration is called for in instant claim 4.
It would be prima facie obvious to one of ordinary skill in the art before the earliest effective filing date following the Farwick in view of Sun and Megumi to administer the composition orally and systemically as taught by KR in light of its teaching that its whitening composition can contain additional antioxidants and its preferred mode of administration is oral administration.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-12 and 17-18 are rejected on the ground of nonstautory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12246079 in view of Sun et al. Bisacurone Inhibits Adhesion of Inflammatory Monocytes or Cancer Cells to Endothelial Cells Through Down-Regulation of VCAM-1 Expression, International Immunopharmacology 8, 1272-1281 (2008).
Specifically, although the claims at issue are not identical, they are not patentably distinct from each other because in the instant case the claims are drawn to a method of whitening the skin comprising administering to a patient in need thereof an effective amount of a composition comprising bisacurone; wherein administering said composition whitens the skin of the patient.
Claims 1-12 of US Patent No. 17/980169 are drawn to a method of whitening the skin comprising administering to a patient in need thereof an effective amount of a composition comprising bisacurone; wherein administering said composition whitens the skin of the patient.
Claims 1-12 of US Patent No. 17/980169 differ from those of the instant application in that they do not teach an effective amount of a composition comprising bisacurone and they do not teach an alcohol solvent extraction to obtain the extract of turmeric rhizome. These deficiencies are made up for with the teachings of Sun.
The teachings of Sun are described supra. It would be prima facie obvious for a skilled artisan before the earliest effective filing date following the method of US Patent No. 12246079 to use 220 mg purified bisacurone in the method as the amount of purified bisacurone in order to be certain that an effective amount was used and to provide the composition with anti-oxidant and anti-inflammatory activities as taught by Sun.
It would be prima facie obvious to one of ordinary skill in the art before the earliest effective filing date following the method of US Patent No. 12246079 to use methanol solvent extraction of turmeric rhizome to obtain bisacurone as taught by Sun in order to have a simple alcohol solvent extraction method that is effective at obtaining bisacurone as taught by Sun.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH CHICKOS/
Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
