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 1-5 are pending and examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 4-5 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 or alleviating diabetes, does not reasonably provide enablement for preventing diabetes. 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.
Limited amount of guidance and limited number of working examples in the specification
Applicant teaches suppressing postprandial blood sugar to alleviate symptoms of diabetes (Specification [10]). However, the prevention of onset of diabetes Type 1 is not possible.
Nature of the invention
There are two types of diabetes. Type I diabetes results from physiological error due to the inability of beta cells of the islets of Langerhans to secrete insulin due to genetic disposition or viral infection. Type II diabetes is due to malabsorption of glucose or impaired utilization of peripheral insulin or due to abnormal erythrocyte receptors (see McPeak et al., US 6303586 B1, column 1, lines 42-55). Thus, it would be impossible to prevent someone from getting diabetes through genetic dispositive.
State of the prior art
There are many causes of diabetes. For those born with insulin deficiency, the prevention of diabetes onset is not preventable.
Predictability or unpredictability in the art
Diabetes.org teaches that Type I diabetes can occur in people who inherit risk factors from both parents and had early stage diet with solid foods (http://www.diabetes.org/diabetes-basics/genetics-of-diabetes.html, page 1, Type 1 Diabetes, paragraphs 1 and 3). Diabetes is common for American and Europeans who eat too much fat and too little carbohydrates and fiber and lack exercise (page 1, paragraph 2). Obesity is a strong risk factor for type 2 diabetes (page 1, Type 2 Diabetes, paragraph 4). Gestational diabetes is more common in women who have a family history of diabetes (page 2, lines 1-2).
The odds of a child getting diabetes from a father with type 1 diabetes is 1 in 17, while the odds from a mother with type 1 diabetes ranges from 1 in 25 to 1 in 100 (page 2, Type 1 Diabetes: Your Child’s Risk, paragraph 1). The odds change with immune disorders, thyroid disease and adrenal gland dysfunction in the parents (page 2, Type 1 Diabetes: Your Child’s Risk, paragraph 4). White people with type 1 diabetes have genes called HLA-DR3 or HLA-DR4 (page 2, Type 1 Diabetes: Your Child’s Risk, paragraph 5). Type 2 diabetes risk is higher when both parents have type 2 diabetes, 1 in 2 (page 2, Type 2 Diabetes: Your Child’s Risk, paragraph 3).
Because of the many causes of diabetes, the unpredictability in the art would be high.
The breadth of the claims
Applicant’s claim is drawn toward preventing onset of diabetes. While Applicant's Specification teaches using diet to control blood sugar diabetes, the practice of preventing diabetes in people born with diabetes is not possible (see http://www.diabetes.org/diabetes-basics/genetics-of-diabetes.html). Applicant is enabled for food product to address health needs of diabetic but not for preventing one from getting diabetes. Thus, the breadth of the claims is broad, particularly for preventing onset of diabetes.
Applicant’s claims are broadly drawn to a composition that is able to prevent diabetes. In order to be enabled for prevention of a condition, applicant must demonstrate that the invention is able to prevent the condition each and every instance of that condition. Applicant’s specification does not set forth any evidence that the claimed product is able to prevent diabetes for all potential causes of diabetes. In addition, the art teaches diabetes prevention is not accepted as possible because many risk factors such as age, race and family history cannot be controlled (see discussion above). Because applicant’s specification does not show prevention of diabetes and the art acknowledges that prevention is not currently possible, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually functions as claimed. Therefore, the claims are not considered enabled for the prevention of diabetes.
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 2 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.
The term “hot” in claim 2 is a relative term which renders the claim indefinite. The term “hot” 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. What is the temperature for the extract to be considered “hot”?
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 1-5 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. Claim(s) 1-5 are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims coffee extract, which are from coffee. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, in claim 3, the extraction of different temperatures of the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application.
The homogenized composition of the different temperature coffee extracts together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, there are no amounts. The mixing of homogenized coffee extracts are well understood, routine, and conventional method of making a product for supplementing nutrition (see below). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible 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.
Claim(s) 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tian et al.(CN 105494582 A).
Tian et al. teaches a health-care coffee is obtained by the following method: coffee bean into the furnace temperature is 195 to 205 ℃, the highest temperature of the furnace is not more than 230 ℃, controlling the heating speed to make the coffee into the furnace after 16 minutes, coffee colour and after discharging the colour Agtron plate of 65 # to 55 #, controlling heating speed is as follows: firstly baking test according to the calculated preset parameter, determining the initial parameters, and then corrects the obtained initial parameters, to obtain the best baking parameters the most, at last baking according to the best baking parameters (page 5, paragraph 2).
Products has strong antioxidant activity, not only can be drunk, but also can be used as other applications to bring benefit to the human body (Abstract), including diabetes ((page 2, paragraph 2).
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 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.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tian et al. (CN 105494582 A).
Tian et al. teaches a health-care coffee is obtained by the following method: coffee bean into the furnace temperature is 195 to 205 ℃, the highest temperature of the furnace is not more than 230 ℃, controlling the heating speed to make the coffee into the furnace after 16 minutes, coffee colour and after discharging the colour Agtron plate of 65 # to 55 #, controlling heating speed is as follows: firstly baking test according to the calculated preset parameter, determining the initial parameters, and then corrects the obtained initial parameters, to obtain the best baking parameters the most, at last baking according to the best baking parameters.
As the optimization, the invention health-care coffee is obtained according to the following steps:
1, the preheating to 195 to 205 ℃ degrees centigrade, then adding W0 g of coffee raw beans;
2, raw coffee bean heat lowering the baking temperature to drop to a certain temperature is not lowered and gradually raising the temperature is the inflection point, recording the coffee raw beans into roasting machine to that the time required for inflection point is T0 minutes, the inflection point temperature is C0 Cº degrees centigrade;
calculating the preset parameter to the target 3, the total baking time is 16 minutes, coffee coffee of 230 ℃ to realize the colour Agtron plate is 65 # to 55 # are:
residual baking time T1 = (16-T0) minutes.
raising the temperature interval C1 = (230-C0 degrees centigrade);
target temperature rise rate of =C1/T1 degrees centigrade per minute;
4 from the T0 minutes every 0.5 to 1.5 minutes of the same time recording the current coffee temperature, thereby calculating the current raising speed, and after comparing with the target heating speed adjusting fire to make the current of the temperature raising speed and target speed error is not greater than 2 ℃ degrees centigrade/min, the heating of the total heating temperature interval is not greater than C1 (page 5, paragraph 2, items 1-4). 0.5 minutes would be 30 seconds.
Products has strong antioxidant activity, not only can be drunk, but also can be used as other applications to bring benefit to the human body (Abstract), including diabetes (page 2, paragraph 2). The different time point coffee extracts can be combined to detect different anti-oxidant stages of the coffee extract.
However, Tian et al. does not teach 3-6 minutes.
The reference does not specifically teach performing the process in the time span and temperature range claimed by applicant. Tian et al. teaches a health-care coffee is obtained by the following method: coffee bean into the furnace temperature is 195 to 205 ℃, the highest temperature of the furnace is not more than 230 ℃. At different time segments a sample of coffee is taken out not to exceed 16 minutes. The process in the time span and temperature range is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal process in the time span and temperature range to use in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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