DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, 13 and 21 are pending.
Priority
This application is filed 11/03/2023, and claims the benefit of domestic priority as below:
PNG
media_image1.png
232
682
media_image1.png
Greyscale
Information Disclosure Statements
No IDS(s) received.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellorini et al. (WO 2013/072304 A1, pub’d 05/23/2013), in view of Parikh et al. (US 9345772 B1, pub'd 05/24/2016).
With respect to independent claim 1, the claim recites that a pharmaceutical preparation of T4 thyroid hormone, in ready-to-use packaging, consisting of a container pre-filled with an alcohol-free water-glycerol solution of hormone T4, said container being selected from (a) a one-component LDPE plastic container, placed in a sealed sachet consisting of laminated films made of a plurality of different materials; or (b) a multi-component laminated plastic container, said container comprising multiple layers of plastic materials.
Bellorini teaches a single-dose pharmaceutical preparation of T3 and T4 thyroid hormones suitable for oral administration, in ready-to-use packaging consisting of a container pre-filled with a water-alcohol solution of hormone T3 and/or T4, said container being selected from (a) a one-component LDPE plastic container; and (b) a multi-component laminated plastic container (claim 1). Bellorini further teaches a sealed sachet consisting of a laminated film made of materials selected from the following: polyethylene, aluminium, polyethylene, terephthalate, ionomer resins, ethylene vinyl alcohol copolymer resins, polypropylene, and fluorinated-chlorinated resins, and multiple layers of plastic materials selected from polyethylene, ethylene vinyl alcohol copolymer resins, polyvinyl chloride, polyvinylidene chloride, polyvinyl acetate, fluorinated-chlorinated resins, ionomer resins, cyclic olefin copolymers, polyamide, polystyrene, polycarbonate and laminated metals (claim 1). Thus, Bellorini teaches 1) a pharmaceutical preparation of T4 thyroid hormone, 2) ready-to-use packaging, 3) pre-filled solution of hormone T3 and/or T4, 4) a LDPE plastic container, and its sealed sachet materials, and 5) a multi-component laminated plastic container with its materials.
Bellorini fails to teach an alcohol-free water glycerol T4 solution.
Parikh teaches that storage stable pharmaceutical solution comprising levothyroxine, glycerol, and water (claims 1 and 8). Parikh further teaches claimed levothyroxine solutions have the advantageous property of being stable while having reduced ingredient complexity and specifically states that “In contrast to prior levothyroxine solutions, certain embodiments of levothyroxine solutions according to the present invention are stable without the need for storage under nitrogen, despite: (i) comprising significant amounts of glycerol and no, or low amounts, of ethanol. “ (column 4, lines 53-59). In addition, the Example 3-6 describes solution containing 80-95g glycerol, water, EDTA, and levothyroxine sodium, without ethanol. Although, certain examples of Parikh include a base and/or EDTA, such exemplary embodiments do not teach away from Parikh’s broader disclosure of stable levothyroxine formulations comprising glycerol and water with no or low amount of ethanol. See MPEP 2123; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971); and In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
It would have been obvious to a PHOSITA at the time of the invention to use the storage stable, glycerol/water levothyroxine formulation having no or low amounts of ethanol taught by Parikh for the ethanol containing T4 solution of Bellorini and to package that solution in the known barrier packing taught by Bellorini. The instant specification itself further recognizes that the packaging arrangements recited in the claim are already described in Bellorini. A person of ordinary skill in the art would have been motivated to use of a known stable T4 formulation in a known T4 packaging system because such solvent system would provide storage stable package. Thus, a person of ordinary skill in the art would have expected the combination to provide a stable, ready to use packaged T4 pharmaceutical preparation while avoiding or reducing the use of ethanol.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Consistently, applying KSR example rationale (A) in the independent claim 1, it would have been prima facie obvious to combine the alcohol free glycerol/water levothyroxine formulation of the Parikh with the barrier packaging of Bellorini because such a combination represents the predictable use of known elements according to their established functions including a stability and ready to use packaged T4 formulation, yielding predictable results. (see MPEP 2141)
With respect to claim 13, the claim recites that a method of treating a disease associated with T3 and/or T4 hormone deficiency, the method comprising administering a pharmaceutical preparation according to claim 1 to a patient in need thereof.
Bellorini teaches a pharmaceutical preparation for use in the treatment of diseases associated with T3 and/or T4 hormone deficiency. (claim 7) Bellorini further teaches that the alcohol is used as a solvent in the formulation rather than as the therapeutic active component (page 3 lines 19-24).
Therefore, claim 13 would have been obvious for the reason stated above with respect claim 1.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellorini et al. (WO 2013/072304 A1, pub’d 05/23/2013) and Parikh et al. (US 9345772 B1, pub'd 05/24/2016) as applied to claim 1 above, and further in view of Vita et al. (Switching levothyroxine from the tablet to the oral solution formulation corrects the impaired absorption of levothyroxine induced by proton-pump inhibitors, J. Clin. Endocrinol. Metab., 99(12), 4481-6, pub’d 9/26/2014).
With respect to claim 21, the claim recites that a method of treating patients who undergo bariatric surgery, patients whose gastric pH is altered and have absorption problems, or patients having absorption problems caused by intake of food, the method comprising administering the composition of the pharmaceutical preparation to a patient in need thereof.
The combination teachings of Bellorini and Parikh are discussed above in claims 1 and 13.
The combination fails to teach administering the claimed pharmaceutical preparation to patients who undergo bariatric surgery, patients whose gastric pH is altered and have absorption problems, or patients having absorption problems caused by intake of food.
Vita teaches that 1) proton pump inhibitors impair the intestinal absorption of tablet levothyroxine by increasing gastric pH and decreasing dissolution of levothyroxine in the stomach (abstract); 2) treating such patients with an oral liquid levothyroxine formulation and reports that switching patients from tablet levothyroxine to liquid levothyroxine at the same daily dose corrected the impaired absorption caused by proton pump inhibitors (abstract); and 3) patients who underwent bariatric surgery dramatically normalize serum TSH after the switch from the tablet to the oral solution LT4 (discussion section). Thus, Vita concludes that liquid levothyroxine continued to be absorbed despite the increased gastric pH.
It would have been obvious to a PHOSITA at the time of the invention to administer the alcohol free liquid levothyroxine preparation resulting from the combination of Bellorini and Parikh to patients having levothyroxine absorption problems associated with increased gastric pH, as taught by Vita, because Vita teaches that a liquid levothyroxine formulation overcomes or correct the impaired absorption caused by increased gastric pH. A person skilled in the art would have been motivated by the benefit of maintaining effective levothyroxine absorption in patients who exhibit reduced absorption of conventional levothyroxine due to elevated gastric pH. Thus, a person skilled in the art would have used Bellorini’s stable, ready-to-use liquid T4 formulation, modified into Parikh’s alcohol-free glycerol/water formulation, for the patient population identified by Vita, expecting the liquid formulation to alleviate absorption issues associated with elevated gastric pH.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10537538 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 1 is obvious in view of claims 1 of ‘538.
Regarding instant claim 1, claim 1 of ’538 teaches the scope of the instant claim 1. Specially, a ready- to-use pharmaceutical preparation of T4 thyroid hormone, package, container, pre-filled with a liquid pharmaceutical composition, alcohol-free water glycerol solution, one component LDPE plastic container placed in a sealed laminated sachet, a plurality of different materials, and material list recited in ‘538 would have been an obvious to a pharmaceutical preparation of T4 thyroid hormone of the instant claim 1.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 10537538 B2 in view of WO 2013/072304 A1.
‘533 teaches a pharmaceutical preparation of T4 thyroid hormone as discussed above. ‘304 teaches that a pharmaceutical preparation for use in the treatment of diseases associated with T3 and/or T4 hormone deficiency. (claim 7) Although, the preparation of ‘304 contains alcohol, the alcohol is used as a solvent in the formulation rather than as the therapeutic active component (page 3 lines 19-24). It would have been obvious to one of ordinary skill in the art to administer the alcohol free T4 pharmaceutical preparation of ‘538 to a patient suffering from a disease associated with T3 and/or T4 hormone deficiency, because ‘304 teaches the administration of T3 and/or T4 containing pharmaceutical preparations for treating diseases associated with T3 and/or T4 hormone deficiency. One of ordinary skill in the art would have had a reasonable expectation that the T4 containing preparation of ‘538 would be effective for such treatment because T4 is the same thyroid hormone used for treating the hormone deficiency conditions disclosed in ‘304.
Claims 1and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11096913 B2 in view of WO 2013/072304 A1.
Regarding claim 1, claim 1 of ’913 teaches the scope of the instant claim 1. Specially, a pharmaceutical preparation of T4 thyroid hormone, container, pre-filled with a liquid pharmaceutical composition, alcohol-free water glycerol solution, a single dose plastic container, and one component LDPE plastic container.
‘304 teaches that a pharmaceutical preparation for use in the treatment of diseases associated with T3 and/or T4 hormone deficiency. (claim 7) Moreover, ‘304 teaches one component LDPE plastic container placed in a sealed laminated sachet, a plurality of different materials, and material list as the instant limitations (page 4 lines 20 - page 5 line 5). Although, the preparation of ‘304 contains alcohol, the alcohol is used as a solvent in the formulation rather than as the therapeutic active component (page 3 lines 19-24). It would have been obvious to one of ordinary skill in the art to use one-component LDPE plastic container that is suitable for storing and dispensing T3 and/or T4 containing pharmaceutical, and administer the alcohol free T4 pharmaceutical preparation of ‘538 to a patient suffering from a disease associated with T3 and/or T4 hormone deficiency, because ‘304 teaches the suitable container and the administration of T3 and/or T4 containing pharmaceutical preparations for treating diseases associated with T3 and/or T4 hormone deficiency. One of ordinary skill in the art would have had a reasonable expectation that suitable one-component LDPE plastic container and the T4 containing preparation of ‘538 would be effective for such treatment because T4 is the same thyroid hormone used for treating the hormone deficiency conditions disclosed in ‘304.
Conclusion
Claims 1, 13 and 21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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, Clinton A. Brooks can be reached at 571-270-7682. 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.
/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights