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
Claims 1-26 are pending. Claims 1-26 are examined on the merits.
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 25 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 25 and 26 is/are directed to a dosage form for topical application to the skin or mucosal membrane in the form of a serum, cream, lotion, conditioner or shampoo, wherein said dosage form comprises a composition as defined in claim 1, and wherein the concentration of Nigella sativa seed oil in said dosage form is in the range of 0.1% w/w to 100% w/w.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, an oil extract of Nigella sativa seed, because there is no indication that extraction has caused the components of Nigella sativa seed that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components Nigella sativa seed oil.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 25 and 26 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claims 25 and 26 require certain amount of components being present in the composition. However, there is no indication that the amounts claimed in the compositions result in a markedly different characteristic for the composition as compared to the components that occur in the nature.
Regarding claims 25 and 26, the presence of water in the claimed serum and beverage does not result in a markedly different characteristic for the claimed composition because plant materials already comprise water and thus have that same characteristic.
Regarding claims 25 and 26, dosage form could be either taking orally or topically, does not result in a markedly different characteristic because the thymoquinone and free fatty acids in Nigella sativa seed already have the characteristic of being in a form suitable for oral consumption. Regarding claim 25, the plant collection and plant extraction process already involve the contact of human skin with plant material and thus have the same characteristic.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 4-26 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zeilkha et al (WO 2020157748 A1).
Zeilkha et al teach in one preferred embodiment of this composition, the TQ concentration is about 3% (w/w) (thus at least 2.5%), the FFA concentration is 1.7% (thus 2.5% or less; 2.0% or less, thus claims 1 and 2 are met, thus claims 19, 20, and 25 are met; thus claim 5 is met) and the concentration of astaxanthin is about 15% (w/w) (page 8, 2nd paragraph).
Zeilkha et al teach the composition according to claim 18, wherein the weight ratio of FFA to TQ is equal to or less than 1: 1 (see claim 19) (thus claim 4 is met).
Zeilkha et al teach this oil had the following composition p-cymene and carvacrol (page 22, middle of the page) (thus claim 7 is met).
Zeilkha et al teach the composition according to claim 12, wherein the TQ is present in Nigel/a sativa (NS) oil (see claim 13).
Zeilkha et al teach the composition according to claim 13, wherein the NS oil is a cold-pressed oil (thus claim 6 is met).
Zeilkha et al teach a method for treating, inhibiting or preventing inflammatory diseases or disorders comprising administering to a mammalian subject in need of such treatment a composition according to any of the preceding claims (see claim 27).
Zeilkha et al teach the method according to claim 17, wherein the mammalian subject is a human (see claim 28).
Zeilkha et al teach in another embodiment the compositions may be formulated for topical administration, for example as creams, ointments or lotions for application to the skin or external mucous membranes, or as pessaries for rectal or vaginal administration (page 11, 2nd paragraph from the bottom) (thus claim 25 is met).
Zeilkha et al teach a typical daily dose for the method of treatment disclosed above would be a single capsule containing 500mg of the composition, of which 15mg would be TQ (page 10, last paragraph) (thus claim 26 is met).
Zeilkha et al teach many, but not all, of the pharmacologically active agents are present in the oil contained within the NS seed (page 1, 2nd paragraph from the bottom).
Applicant is noted that since “preventing” presents throughout the claims, it does not require the patient population has microbial overgrowth, as long as the claimed composition is being administered to a subject, it is inherent that the claim is going to perform the claimed designated function, which is to prevent skin mucosa, and systemic conditions resulting from microbial overgrowth, thus claims 1, 2, and 4-26 are met.
Therefore, the reference is deemed to anticipate the instant claim above.
Applicant could overcome this rejection by deleting the word “preventing” throughout the claims.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-5, 7-9, 12, 14-18, and 21-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thakur et al (Thakur et al, Nigella sativa (Kalonji): a black seed of miracle. International Journal of Research and Review (2021), 8(4), 342-357).
Thakur et al teach it is recommended by the World health organization (WHO) that most of the world's population depends on herbal medicine for their health care. Nigella sativa is commonly known as a Black seed, Black cumin or 'Habbatul Barakah' i.e. an annual herb possessing a wide range of medicinal uses apart from its com. significance as a spice yielding plant. It has long been used in the folk medicine system of the Arabian Gulf region, Far East Asia, and Europe. Seeds and oils of N. Sativa are the primary medicinal source from ancient times. It is one of the most common herbal plants used worldwide and possesses various chem. constituents such as thymoquinone (thus the claimed component), thymohydroquinone, dithymoquinone, thymol, nigellicine, carvacrol (thus claim 7 is met), nigellicine, nigllimine, nigellidine, and alpha-hederin. There are more than 100 constituents isolated from the plant. These chem. compds. have many pharmacol. activities such as antibacterial, antiviral, anti-inflammatory, wound healing effect and also for acne vulgaris, skin cancer, pigmentation and many other cosmeceutical properties. Much scientific research on N. sativa has been conducted over the last five decades to investigate chem. and pharmacol. properties. In this review, the phytochems., pharmacol. properties, Ayurvedic properties and folk uses of Nigella sativa are briefly explained (see Abstract).
Thakur et al teach many scientific studies have been done and observed that the effect of Nigella sativa oil against acne vulgaris (thus a method for treating skin mucosal and systemic conditions resulting from microbial overgrowth, imbalance or infection, thus claims 22-24 are met). Hadi and Ashok examined in their study that using 20% of N. sativa oil extract (thus claim 25 is met) in the lotion (thus claims 18 and 25 are met) (thus claim 17 is met) formulation has better efficacy. 62 patients (thus claim 24 is met) who has acne were selected for the study. Results showed Nigella sativa has less harmful than benzoyl peroxide lotion (page 349, 1st column, 3rd paragraph).
Thakur et al teach a few recent studies have been done on the antiviral effect of Nigella sativa. A study was held in 2013 which showed significant results about the effect of N. sativa oil against hepatitis C virus (HCV). A clinical study was done on 30 patients with HCV who were not eligible for IFN/ribavirin therapy. 450 mg of N. sativa oil in capsular dosage (thus claims 21 and 26 are met, thus systemic administration) form were administered orally 3 times daily. After 3 months, a reduction in overall viral counts and improved oxidative stress was noted (page 347, 1st column, third paragraph).
Thakur et al teach to evaluate the anti-fungal activity a micro well dilution assay was performed against three human pathogenic fungal strains that are Aspergillus flavus, Aspergillus niger, Candida albicans (thus claims 9 and 12 are met) and four bacteria i.e. Escherichia coli, Staphylococcus sp., Pseudomonas syringae and Bacillus subtilis. It was found that the methanolic extract of N. sativa shows maximum inhibitory potential against all the test fungi and bacteria (page 347, 2nd column, last paragraph).
Thakur et al teach many studies have been reported the antibacterial activity of N. sativa. Thymoquinone is the major chemical constituent isolated from this plant. It was found to have antibacterial activity against most bacteria especially in Gram-positive cocci type such as staphylococcus aureus (thus claim 15 is met) and staphylococcus epidermidis (page 347, 1st column, 2nd paragraph).
Thakur et al teach fixed oil isolated from the N. sativa species are linoleic acid (55.6%), oleic acid (23.4%) and palmitic acid (12.5%) (thus the claimed FFAs) (page 344, 2nd column, 2nd paragraph).
Thakur et al teach do not teach the claimed amount or ratio of thymoquinone or FFAs.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to vary the claimed amount or ratio of thymoquinone and FFAs since both of them are contained in the claimed Nigella sativa seed oil, and the amount or ratio may vary according to the collection season and extraction method. Determining an appropriate amount or ratio of the two components within the composition is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1-5, 7-9, 11, 12, 14-18, and 21-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thakur et al as applied to claims 1-5, 7-9, 12, 14-18, and 21-26 above, and further in view of Kandial (US 20030060508 A1).
The teachings of Thakur et al are set forth above and applied as before.
The teachings of Thakur et al do not specifically teach treating seborrheic dermatitis in claim 11.
Kandial teaches the present invention also provides novel methods for treating and preventing skin conditions by administering to a patient in need thereof an effective amount of a composition comprising the Nigella sativa L. polyunsaturated fatty acid fraction of the present invention or an effective amount of a composition comprising octadecadienoic acid and/or octadecenoic acid. "Skin conditions" includes any skin conditions known in the art, including, for example, psoriasis, eczema, dermatitis, dry skin, scaly skin, itchy skin, and flaky skin. The term "dermatitis" includes, but is not limited to, infantile seborrheic dermatitis, napkin dermatitis, contact dermatitis, atopic dermatitis, neurodermatitis, photodermatitis, urticaria, contact balanitis, hyperkeratosis, exfoliative dermatitis, and acne [0029].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed Nigella sativa to treat seborrheic dermatitis. Since both of the references teach using the claimed plant material Nigella sativa, one of ordinary skill in the art would have been motivated to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1-5, 7-9, 12, and 14-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thakur et al as applied to claims 1-5, 7-9, 12, 14-18, and 21-26 above, and further in view of Syahfitri et al (Syahfitri et al, Formulation and antibacterial activity tests of nanoemulsion gel black cumin (Nigella Sativa L.) ethanol extract. Asian Journal of Pharmaceutical Research and Development (2020), 8(4), 07-11).
The teachings of Thakur et al are set forth above and applied as before.
The teachings of Thakur et al do not specifically teach treating the claimed concentrations in claim 19 and 20.
Syahfitri et al teach black cumin (Nigella sativa L.) is an herbal plant that has the chem. content of essential oil and pharmacol. effect as a broadspectrum antibacterial namely thymoquinone (TQ). This research was carried out by making ethanol ext. of black cumin, formulating it into nanoemulsion gel and testing the antibacterial activity against pathogenic bacteria in the skin. Black cumin seeds macerated with 80% alc. and concd. with a rotary evaporator. Black cumin ethanol ext. is formulated into nanoemulsion gel using spontaneous emulsification with concns. of 3%, 5% and 7% (claims 19 and 20 are met). The prepn. is stored and evaluated for 12 wk at room temp. Evaluation of prepn. quality includes organoleptic, viscosity, particle size, centrifugation and cycling test. Antibacterial activity test of nanoemulsion gel of black cumin ethanol ext. was carried out by cup-plate technique using Staphylococcus aureus, Staphylococcus epidermidis dan Propionibacterium acne. The ext. yield was 18,37% wt./wt. All formulas were stable during 12 wk storage, viscosity 2850-3750 mPa.s, particle size around 45,85-419,78 nm, centrifugation results and cycling tests showed no sedimentation and phase sepns., so it were said to be phys. stable. The results of the antibacterial activity test showed the value of min. inhibitory concn. (MIC) of Staphylococcus aureus bacteria in F1, F2 and F3 resp. 7,83; 8,93 and 10,00 mm, Staphylococcus epidermidis bacteria 6,63; 7,67 and 8,43 mm, Propionibacterium acne bacteria 6,43; 7,47 and 7,83 mm. The results of the study concluded that nanoemulsion gel of black cumin ethanol ext. with a concn. of 7% is the best formula because it is stable during storage, has the greatest antibacterial activity against pathogenic bacteria in the skin (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed concentrations of 3%, 5% and 7% Nigella sativa to obtain the claimed antibacterial activity since Syahfitri et al teach to do so. Since both of the references teach using the claimed plant material Nigella sativa to obtain the claimed antibacterial activity, one of ordinary skill in the art would have been motivated to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1-5, 7-9, 12-18, and 21-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thakur et al as applied to claims 1-5, 7-9, 12, 14-18, and 21-26 above, and further in view of Khan et al (Khan et al, Liposomal thymoquinone effectively combats fluconazole-resistant Candida albicans in a murine model. International journal of biological macromolecules, (2015 May) Vol. 76, pp. 203-8).
The teachings of Thakur et al are set forth above and applied as before.
The teachings of Thakur et al do not specifically teach treating fluconazole-resistant strain of Candida albicans.
Khan et al teach the aim of the present study was to develop a novel liposomal formulation of thymoquinone (TQ) to treat fluconazole-susceptible and -resistant Candida albicans (C. albicans) infections. The liposomal preparation of TQ (Lip-TQ) was used against a fluconazole-susceptible or -resistant isolate of C. albicans. Various doses of fluconazole (0, 5, 10, 20 and 40 mg/kg) or free TQ or Lip-TQ (0, 1, 2 and 5mg/kg) were used to treat C. albicans infected mice. Mice were observed for 40 days post C. albicans infection, and their kidneys were assessed for the fungal load. Fluconazole showed anti-fungal activity against the drug-susceptible, but not against the -resistant isolate of C. albicans. Free TQ showed its activity against both fluconazole-susceptible or -resistant C. albicans, however, Lip-TQ was found to be the most effective and imparted ~ 100% and ~ 90% survival of mice infected with fluconazole-susceptible and -resistant isolates of C. albicans, respectively. Mice treated with Lip-TQ showed highly reduced severity of infection in their tissue homogenates. Therefore, Lip-TQ may effectively be used in the treatment of C. albicans infections, including those which are not responding to fluconazole (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed thyoquinone to treat fluconazole-resistant strain of Candida albicans since Khan et al teach to do so. Since both of the references teach using the claimed thymoquinone to treat Candida albicans, one of ordinary skill in the art would have been to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1-9, 12, 14-18, and 21-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thakur et al as applied to claims 1-5, 7-9, 12, 14-18, and 21-26 above, and further in view of Kiralan et al (Kiralan et al, Physicochemical properties and stability of black cumin (Nigella sativa) seed oil as affected by different extraction methods. Industrial Crops and Products (2014), Volume 57, pp. 52-58).
The teachings of Thakur et al are set forth above and applied as before.
The teachings of Thakur et al do not specifically teach cold-pressing seed oil.
Kiralan et al teach Black cumin (Nigella sativa) oil (BCO) was recovered using different extraction techniques including solvent free system (cold-pressing) and solvent extracted systems (Soxhlet and microwave assisted). Oils were analyzed for the composition of fatty acids and bioactive compounds (sterols, tocopherols, chlorophyll, carotenoid and phenolics profile) and for some physicochemical properties [free fatty acid, peroxide value (PV), refractive index, and ultraviolet (UV) absorption at K232 and K270]. Antiradical power (AP) of oils was also evaluated, wherein cold-pressed oil had stronger AP than solvent extracted oils. Phenolic profiles analyzed by HPLC revealed that thymoquinone was the main phenolic compound wherein high levels of benzoic and p-hydroxy benzoic acids were found in cold pressed-BCO. Oxidative stability (OS) of oils was evaluated during accelerated oxidation conditions (oven test at 60°C and Rancimat test at 110°C). The greatest induction period was 19.6 h for Soxhlet-extracted BCO, and the lowest induction period was 3.48 h for cold-pressed BCO. PV of cold-pressed BCO reached 85.3 meq O2/kg oil, while PV of the other extracted oils were under 27.0 meq O2/kg oil at the end of storage period (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed cold-pressing black cumin (Nigella sativa) seed oil since Kiralan et al teach to do so. Since both of the references teach the claimed Nigella sativa seed oil, one of ordinary skill in the art would have been to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached on 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655