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 .
Priority
The instant application claims priority to U.S. Provisional Application no. 63/239,696, filed September 1, 2021.
Election/Restrictions
3. Applicant’s election of the species, prostratin, in the reply filed on January 9, 2026 is acknowledged.
4. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
5. As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species does not make a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
6. Claims 1-14 are pending and under consideration in the instant application.
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.
7. Claims 5-14 are rejected under 35 U.S.C. 112, first paragraph.
While enabling for a method of treating diabetic disease, obesity, hypertension, hyperlipidemia, hypertriglyceridemia, hypercholesterolemia, arteriosclerosis, or fatty liver disease, diabetes, diabetic ketoacidosis, diabetic acidosis, diabetic xanthoma, diabetic amyotrophy, diabetic ketosis, diabetic coma, diabetic gastric disorder, diabetic gangrene, diabetic ulcer, diabetic complications, diabetic diarrhea, diabetic microangiopathy, diabetic uterine body sclerosis, diabetic cardiomyopathy, diabetic neuropathy, diabetic nephropathy,bullosis diabeticorum, diabetic cataract, diabetic dermopathy, diabetic scleredema, diabetic retinopathy, necrobiosis lipoidica diabeticorum, and diabetic blood circulation disorder, the specification does not reasonably provide enablement for preventing and preventing any metabolic disease, as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the claims is drawn to compositions for the treatment and prevention of metabolic diseases.
(b) Nature of the invention - The nature of the invention is therefore drawn to the pharmaceutical art. These claims cover diseases that are known to exist and those that may be discovered in the future, for which there is no enablement provided.
(c,e) State of the prior art and predictability in the art - The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic or preventative regimen on its face.
While a full discussion of each disease which is encompasses by Applicant’s claim language will not be given, the following examples teach that the state of the prior art with respect to the claimed diseases has not advanced to the point of being predictive of the treatment and prevention of the breadth of diseases instantly claimed.
Regarding the prevention of the aforementioned diseases or conditions - prophylaxis and/or prevention means to anticipate or counter in advanced, to keep from happening, etc. and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds and compositions can be administered in order to have the "preventive" effect. How would one show a correlation that the diseases of the instant claims are prevented by the compounds of the invention, or that the subject would not have contracted the disease without administration of the instantly claimed compounds? How is the initial onset of the full scope of the claimed diseases prevented?
For example: there are two main categories of diabetes: mellitus type I and type II. Treatment involves control of hyperglycemia to improve symptoms and prevent complications while minimizing hypoglycemic episodes. Oral antihyperglycemic drugs are the primary treatment for type II diabetes mellitus. However, there are no treatments that definitely prevent the onset or progression of type I diabetes. http://www.merck.com/mmpe/print/sec12/ch158/ch158b.html.
The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
(d) Level of one of ordinary skill in the art - The artisans using applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
(f-g) Amount of direction provided by the inventor and existence of working examples The only direction or guidance present in the instant specification is the listing of diseases applicant considers as treatable and preventable by the claimed compounds.
There are absolutely no working examples present for the prevention of any metabolic disease in the instant application.
Test assays and procedures are not provided in the specification and the disclosure does not provide how the in vitro data correlates to prevention of any disease, as claimed. The specification does not provide adequate correlation for the treatment and prevention of the broad scope of disorders claimed.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous diseases/disorders or conditions claimed herein. That a single compound or class of compounds can be used to treat all diseases/disorders and conditions embraced by the claim is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all of the diseases/disorders or conditions by administering the instant claimed compounds.
The direction provided is very limited. The applicants have not provided any chemical or biological data and/or testing results of any of the compounds or compositions to treat/prevent the entirety of conditions encompassed by this language. In addition, no definition within the specification to any extent as to what is encompassed by the claim language in the current application. An applicant must clearly identify these things.
The specification does not show any examples where compounds of the claims were used to treat and prevent the full scope of conditions as set forth in the claims. See MPEP 2164.02 (“Compliance with the enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed … Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”). There is a lack of “reasonable correlation” to the vast numbers of diseases encompassed by the full scope of disorders and the entirety of claimed compounds. See MPEP 2164.02 (“The issue of “correlation” is related to the issue of the presence or absence of working examples. “Correlation” as used herein refers to the relationship between in vitro … assays and a disclosed or a claimed method of use. An in vitro … example, in the specification, in effect, constitutes a “working example” if that example “correlates with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” … For a claimed genus [e.g., cardiovascular diseases], representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art … would expect the claimed genus could be used in the manner without undue experimentation”). While Applicants do indeed make various statements in the specification that their claimed compounds will effectively treat the genus of diseases associated encompassed by the claims, such is not supported by examples. That is, the limited testing set forth in the specification does not constitute a “working example” within the meaning of MPEP 2164.02 let alone a “representative” set of examples that would be required the describe this enormous genus.
While enabling for a method of treating the aforementioned conditions, the specification does not reasonably provide enablement for preventing said conditions, as claimed.
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases, disorders, or conditions out of all diseases, disorders, or conditions would be benefited and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment and prevention of the diseases.
A person having ordinary skill in the art at the time the invention was made would be faced with an undue amount of experimentation to use the pharmaceutical compositions for the full scope of the claimed intended uses.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 102
8. 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 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.
9. 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.
10. Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent no. 8,816,122.
U.S. Patent no. 8,816,122 teaches prostratin in col. 42.
Regarding the limitations “composition” “pharmaceutical” “for regulating glucose” “wherein the regulating the glucose comprises regulating glucose absorption in the small intestine or glucose excretion” for preventing or treating metabolic diseases” “wherein the metabolic disease is…” “wherein the diabetic disease is…” “functional food composition” – it is noted that these claims merely recite properties of the anticipated compounds. “Products of an identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990). Since the prior art teaches a product of identical chemical composition to that claimed, and the application discloses that all of the claimed compositions have the claimed properties, these limitations are also anticipated. Since the prior art teaches the identical chemical structure, the properties applicant claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990).
Since the prior art teaches a product of identical chemical compound to that claimed, prostratin, and the application discloses that all of the claimed compositions have the claimed properties and no additional components are claimed (such as an excipient, adjuvant, carrier, no additional components, etc.), these limitations are also anticipated. Therefore, the claims are anticipated by the aforementioned compounds, capable of being used with the claimed intended uses of ‘composition’ and ‘pharmaceutical’ and ‘functional food composition’ as described herein.
MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Since the compositions taught by the prior art do not have any structural difference from the claimed compounds and the prior art compositions are capable of the intended uses, those limitations are also anticipated, as discussed herein. As such, the claims are anticipated.
CONCLUSION
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The Examiner works a flexible schedule and can usually be reached Monday-Friday 9-5PM EST.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Admi Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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