DETAILED ACTION
The receipt is acknowledged of applicant’s IDS and certified copy of foreign priority document, both filed 05/16/2023.
Claims 1-10 are pending and subject of this office 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 .
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. A judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims recite extract or fermented product of pyrus ussuriensis. This judicial exception is not integrated into a practical application because it is used in its natural form as present in nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
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.
Claims 1-10 are directed to “pharmaceutical composition for prevention or treatment of colitis including an extract of pyrus ussuriensis or a fermented product of pyrus ussuriensis as active ingredient.” Claimed 2 directed to extraction method. Claims 3-5 are directed to fermentation method. Claim 6 is directed to types of colitis. Claim 7 directed to inherent property of the extract. Claim 8 is directed to treatment method for colitis including administering the composition of claim 1. Claims 9-10 are directed to food composition, and health functional food, respectively, including the extract of pyrus ussuriensis.
Analysis of the flowchart:
Step 1, is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is drawn to a composition and process of its use.
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 drawn to a composition and process of using a product of nature, an extract or ferment of pyrus ussuriensis product used to treat colitis. There is no indication that extraction or fermentation has caused the components of pyrus ussuriensis to have any characteristics that are different from the naturally occurring components in pyrus ussuriensis.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. Claims of 1-10 do not include additional elements that are sufficient to alter the natural product to amount to significantly more than the judicial exception, as there is no indication that the extract or ferment has been altered by any way that caused active components to have any characteristics that are different from the naturally occurring components.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, in the instant case no additional elements are added to the extract or ferment.
Claim 2 recites water for extraction that reads on wet pyrus ussuriensis plant soaked on water from rain. Further, claims 3-5 recite fermenting medium using sugar that can be the sugar from the plant itself. Regarding claims 6 -8, eating the fruit or consuming any part of of the pyrus ussuriensis plant would reach the colon and exerts its inherent effect of treating colitis, if present. Regarding claims 9-10, inclusion of the natural extract or ferment of pyrus ussuriensis into food or functional food still does not alter the nature of the judicial exception.
There is no indication that any component or any manipulation of the claimed pyrus ussuriensis results in a different characteristic of the pyrus ussuriensis as compared to components of the extract that occur in the nature.
Therefore, the claimed composition and method of its is not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions. Consuming the plant by eating it reads on the claims including the composition and method of its administration.
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 extract or ferment. Further, the method of use claims recite no method steps, other than administration, and 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 § 112
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 1-10 are 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 treating colitis, does not reasonably provide enablement for preventing colitis before it even happens. 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 factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). 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 amount of direction or guidance presented; the (6) relative skill of those in the art; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner's position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention: The invention provides a composition and method of preventing, treating or improving colitis, including administering extract or ferment of pyrus ussuriensis.
(2) The breadth of the claims: The claims are broader in scope than the enabling disclosure. Applicant is purporting treatment, improving and prevention of all colitis types as claimed by claim 6. However, only treatment and not prevention nor cure, of any of the types of colitis as claimed by claim 6 by administering the claimed composition is provided. Applicant provided treatment of diarrhea induced in mice, and not actual treating of any of the claimed conditions claimed by claim 6. The specification discloses treating diarrhea caused by dextran sulfate sodium salt (DSS) in mice. The claim encompasses prevention of disorders that may have potential causes other than those disclosed in the specification, e.g. irritable bowel disease can be autoimmune that may require immunosuppressives. Infection colitis caused by micro-organisms may require antimicrobial agents. Radiation colitis may require only to eliminate radiation, etc. Further colitis is not always accompanied by diarrhea. Prevention and treating colitis may or may not be addressed by the administration of the claimed composition. Moreover, the specification is directed to treating DSS induced diarrheas, and the claims encompass prevention of all kinds of colitis in susceptible patients, and the burden of enabling prevention of colitis would be greater than that of enabling a treatment due to the need of additional testing and screening to those humans and animals susceptible to conditions that may or may not happen. Prevention of colitis may not be addressed by the administration of the instantly claimed composition. Colitis cannot be prevented before it even happens.
(3) The state of the prior art: The prior art does not recognize prevention of colitis or their cure, only treatment. The article Ilhan (“Efficacy of subsp. Elaeagnifolia in acetic acid-induced colitis model”, IDS reference) indicated that colitis can be treated, and not prevented, only treated when it happens.
(4) The predictability or unpredictability of the art: The unpredictability of the prevention of colitis before it happens is very high. The lack of significant guidance from the specification or prior art with regard to completely preventing of the claimed conditions with the administration of the instant composition makes practicing the claimed invention unpredictable in terms of the prevention of colitis.
(5) The amount of direction or guidance presented: The specification has enabled treating colitis with the claimed composition, not prevention, not cure. The specification provides no guidance, in the way written description, that any of the claimed colitis conditions are prevented. This is because it is not obvious from the disclosure of treating a disorder with a composition if the same composition will work in preventing occurrence of the disorder. A disclosure should contain representative examples, which provide reasonable assurance to one skilled in the art that the compounds fall within the scope of a claim will possess the alleged activity. See In re Riat et al. (CCPA 1964) 327 F2d 685, 140 USPQ 471 ; In re Barr et al. (CCPA 1971) 444 F 2d 349, 151 USPQ 724.
(6) The relative skill of those in the art: The relative level of skill possessed by one of ordinary skill in the art of gastroenterology research is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess a Ph.D. or M.D. in a scientific discipline such as gastroenterology, medicinal chemistry, biochemistry, pharmacology, biology or the like.
(7) The presence or absence of working examples: As stated above, the specification has enabled treating chemically induced colitis, but not the prevention of any type of colitis claimed by claim 6, or cure, using the claimed composition.
(8) The quantity of experimentation necessary: The art and the specification demonstrated treating chemically induced colitis in mice. Since the prevention of a disorder before it happens cannot be predicted, but must be determined in each individual from case to case by experimental study, and when the above factors are weighed together, one of ordinary skill in the art would be burdened with undue experimentation to determine susceptible patients and to make/use the instant compositions for preventing different types of colitis, whether responsive to the claimed extract, is entirely prevented without guidance from the specification or the prior art. One of ordinary skill in the art would have to conduct time-consuming and costly experimental methods comprising functional and non-functional assays representing both in vitro and in vivo experiments to determine which "type of colitis" of "a patient" will be effectively treated or prevented by the instantly claimed composition and method. Therefore, undue experimentation becomes the burden of the practitioner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of KR 2015-0096237 (IDS filed 05/15/2023, hereinafter KR ‘237), KR 20180049355 (currently cited in PTO 892 and copy of machine translation is provided, hereinafter KR ‘355), the article by Peng et al. (“Chemical composition and bioactivity evaluation of extracts from pear(Pyrus Ussuriensis Maxim) fruit”, abstract currently provided), the article by Ilhan et al. (“Efficacy of Pyrus elaeagnifolia subsp. Elaeagnifolia in acetic acid-induced colitis model”, IDS filed 05/16/2023), and the article by Dong et al. (“Evaluation of phenolic composition and content of pear varieties in leave from China”, currently provided).
Applicant Claims
Claim 1 is directed to a pharmaceutical composition for prevention or treatment of colitis including an extract of pyrus ussuriensis or a fermented product of pyrus ussuriensis as active ingredient.
Claim 9 is directed to a food composition for prevention or improvement of colitis including an extract of pyrus ussuriensis or a fermented product of pyrus ussuriensis as active ingredient.
Claim 10 is directed to a health functional food composition for prevention or improvement of colitis including an extract of pyrus ussuriensis or a fermented product of pyrus ussuriensis as active ingredient
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
KR ‘237 teaches pharmaceutical composition comprising fermented product of pear (abstract; ¶¶ 0008, 0018, 0026). The composition treats diseases caused by abnormality in the body immune system, e.g. inflammatory bowel disease and atopic dermatitis (¶¶ 0009, 0010, 0012, 0014, 0022, 0023). The composition provides superior immune enhancing properties (¶ 0046).The composition can be in the form of food or health functional food (¶¶ 0012, 0033, 0036-0038). The composition administered to mammals (¶ 0029). The pear is fermented using sugar, e.g. brown sugar, using 26.5 kg of pear and 23.5 kg of brown sugar (¶ 0050). According to Wikipedia, brown sugar is mainly a sucrose, and comprises glucose and fructose. The ratio of the pear to the brown sugar is calculated to be 1:0.8, e.g. 1.25:1.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While KR ‘237 teaches many species of pear, the reference does not explicitly teach the claimed species pyrus ussuriensis claimed by claim 1.
KR ‘355 teaches pyrus suriensis (which is pyrus ussuriensis) is known species of pears (¶ 0007). Pear extract is used to suppress the production of inflammatory factors in cells without toxicity and improve the immune system in animal models (¶¶ 0011, 0021, 0035, 0050, 0071). The pear extract is used in food product and health food products (¶¶ 0017, 0047, 0052-0053). Extraction can use any part of the plant. Water, alcohol, e.g. menthol and ethanol, can be used for solvent extraction (¶¶ 0031, 0032).
Peng teaches extracts from pyrus ussuriensis considered an important source of natural anti-inflammatory agents and are used as functional food (see the provided abstract).
Ilhan teaches treating colitis using pear extracts. Pear extracts comprise phenols that suppress the inflammatory factors and treat colitis, e.g. ulcerative colitis (see the entire document; and in particular abstract; pages 14, 16, 19-20).
Dong teaches pyrus ussuriensis is rich in phenolic compounds that are natural antioxidant source in functional food (see the entire document, and in particular abstract; Table 2; conclusion).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide food composition comprising ferment pear product to treat irritable bowel disease caused by abnormality in the immune system as taught by KR ‘237, and use extract from pyrus ussuriensis taught by KR ‘355 and Peng in the food product. One would have been motivated to do so because KR ‘355 teaches pyrus ussuriensis is known species of pears and pear extract is used to suppress the production of inflammatory factors in cells without toxicity and improve the immune system in animal models, and because Peng teaches extracts from pyrus ussuriensis considered an important source of natural anti-inflammatory agents and are used as functional food. One would reasonably expect formulating food composition comprising pear ferment or extract from pyrus ussuriensis that increases the immunity of the subject and suppresses inflammatory factors without toxicity and successfully treats irritable bowel disease that is caused by abnormality in the immune system.
Further, one having ordinary skill in the art would have used pyrus ussuriensis to treat colitis because colitis is treated by phenolic compounds from pyrus as taught by Ilhan and pyrus ussuriensis is rich in phenolic compounds as taught by Dong.
Regarding water or alcohol extraction wherein alcohol has 1-4 carbon atoms as claimed by claim 2, KR ‘355 teaches water extraction or extraction using methanol or ethanol, that are the claimed alcohols having 1-4 carbon atoms.
Regarding claim 3 that the composition comprises the fermented product is obtained by mixing and fermenting a pyrus ussuriensis and sugar, KR 355 teaches ferment product of pyrus plant and brown sugar.
Regarding claim 4 that the sugar comprises sucrose, maltose, glucose, fructose and refined sugar, KR ‘355 teaches brown sugar that is mainly sucrose and further comprises glucose and fructose.
Regarding claim 5 that the fermented product is a mixture of a pyrus and sugar in a weight ratio of 5:5 to 7:3, KR ‘355 teaches ratio of 1.25:1 that falls within the claimed ratio. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding colitis species claimed by claim 6, KR ‘237 teaches inflammatory bowel disease, and Ilhan teaches ulcerative colitis.
Regarding claim 7 that the composition provides an effect of reducing disease activity index (DAI), reducing diarrhea index, or reducing bloody stool index, the cited references in combination teaches the claimed composition, and it is expected to provide the claimed function of claim 7 since materials and their properties are inseparable.
Regarding the treatment method claimed by claim 8 comprising the step of administering to other than human, KR ‘237 teaches mammals that include other species than human, and KR ‘355 and Ilhan teaches administration to animals.
Regarding food composition claimed by claim 9 and functional food composition claimed by claim 10, KR ‘237, KR ‘355, Peng and Dong all teach food and functional food compositions.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/ Primary Examiner, Art Unit 1611 /I.G./