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 .
Information Disclosure Statement
An information Disclosure Statement was filed 06/05/2024.
A preliminary amendment was filed 09/19/2024.
Election/Restrictions
After review of the election/restriction, and the amendment of the claims on 04/28/2026, the election of species is withdrawn.
Specification
The disclosure is objected to because of the following informalities: At page 26, between lines 14 and 15, Brief Description of the Figures, should be amended to Brief Description of the Drawings.
Appropriate correction is required.
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 32-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) determined that factors which enable an invention. These are:
(A) The breadth of the claims;
The instant claims set out a treatment for obesity through oral administration of orlistat and acarbose, without a rebound of weight .
(B) The nature of the invention;
The invention involves oral administration of orlistat and acarbose as a treatment of obesity,
(C) The state of the prior art;
The art of treating obesity teaches the combination of drugs through various routes.
(D) The level of one of ordinary skill;
The ordinary practitioner is either a PhD or medical practitioner
(E) The level of predictability in the art;
As with any infection, patient response to medication is not always predictable. This is especially the case for obesity and treating over weight patients. Rebound of weight gain is common.
(F) The amount of direction provided by the inventor:
Example 3 seems to show that a rebound effect is present after 6 month from the end of treatment with both EMP16-120/40 and EMP16 150/50, wherein the subjects regained all their lost weight (see Tables 9 and 10).
(G) The existence of working examples;
There are working examples such as page 11, line 22 et seq, sets out a synergistic effect between oral administration of orlistat and acarbose as compared to administration of a single agent. However, enablement for these percentages is unclear as it does not appear to come from applicant’s data, and does not support a lack of rebound.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Because each patient response is unique in response to weight loss treatments, each one must be evaluated by carefully step by step as to dosage, frequency, weight loss, efficacy, and prrof of no rebound weight gain. This involves painstaking, undue experimentation to determine what is efficacious, and what if any side effects .
The claim for treatment of obesity without rebound is not enabled by the original specification.
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 34 and 49 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.
Regarding claim 34, a BMI of the subject is 27 kg/m2 or more. Obesity is measured at 30 or more. The claim does not refer to an obese subject. Clarification is requested.
Claim 49 is indefinite in setting out “cellulose, cellulose derivatives, hydroxypropyl methylcellulose”. Hydroxypropyl methylcellulose is a cellulose and a cellulose derivate. Therefore the metes and bounds of the claims are indefinite.
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.
Claim(s) 32-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/097170A (Empros Pharma).
Regarding claim 32, , Empros Pharma discloses an oral formulation for the treatment of obesity comprising orlistat and acarbose (see Abstract). With respect to claim 33 the percentage of parts G1 to G2A is 5% - 95% acarbose, and 10% -90% orlistat. Example 6 , specifically recites the amount of 90 mg of orlistat and 30 mg acarbose. Either falls within the claimed percentage of claim 33. Regarding claim 34 , the BMI of an obese patient is 30 or more. With regard to claim 38, Example 6 administers the formulation twice. Example 6 also discloses the dosage of claims 39 - 41. The treatment period lasts for 4-56 weeks (page 9, lines 25-28) and reads on claim 42. Regarding claim 43 , the composition is disclosed to comprise particles at page 9, line 12 , page 14, lines 24-26, page 29, lines 10-13 . Sizing of the API particle size can be modified as far as nanoscale ( page 37, lines 21-22), which would include “below 50 microns” of claim 44. Also see page 54, last line for a specific reference to micronizing. The device of Empros Pharma may have multiple compartments or parts with different release profiles (page 11, line – page 17, line 22), and reads on claims 45-47. Release to different parts of the GI tract is disclosed at page 14, lines 20 et seq to page 15, line 30. The contents are released in the stomach, duodenum and jejunum. At page 29 under “Formulation of the G1, G2,and G3 parts of the composition” various coating as proposed as possible embodiments are listed through page 39 , line 12, which includes, hydrophilic, hydrophobic, enteric and protective layers. Various cellulose derivates are specifically taught at page 31, lines 25-28, with microcrystalline cellulose specifically recited at page 29, lines 8-9. At page 5, line 19, orlistat alone causes a 10% weight loss, so that the combination of orlistat and acarbose would be expected to have a weight loss of at least 5% as set out in claim 58. As such , those of ordinary skill in the art would expected similar weight loss to that of the instant claims given the teachings of Empros Pharma. While Empros Pharma does not disclose prevention of rebound, applicant has claimed the same method using the same overlapping formulations. It is applicant’s burden to show that their formulations have an unexpected advantage over those of Empros Pharma in reducing rebound weight gain. There are no unexpected and/or unusual results which would rebut prima facie obviousness at this time. Therefore, the instantly claimed method would have been obvious to one of ordinary skill at the time of filing given the teachings of Empros Pharma.
Conclusion
No claims are allowed.
The article by Holback et al and US Patent No. 10,561,617 are cited for teaching oral combinations of orlistat and acarbose
Correspondence.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
Prosecution Insights