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 34-50 are currently pending and a preliminary amendment to the claims filed on 05/15/2025 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The three (3) information disclosure statements (IDS) submitted on 02/05/2025; 03/06/2025; 07/07/2025 were filed before the mailing date of the instant first action on the merits. The submissions thereof are following the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, signed and initialed copies thereof are enclosed herewith.
Specification
The abstract of the specification is objected to a minor informality.
Applicant is reminded of the proper content of an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc. See MPEP 608.01(b)
In the instant case, the abstract is simply written as follows:
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That is, the current abstract is not descriptive by not complying with the above guideline. Accordingly, appropriate correction is requested.
Claim Objections
Claims 35, 42, 45 and 50 are objected to a minor informality.
Claim 35 recites unnecessary opening bracket symbol “[ ” before “comprises” in line 2. Removal is respectfully requested.
Claim 43 recites “an mount”, but which typo should be corrected to “an amount”.
Each of claims 42, 45 and 50 reciting “one or more .., in the group of …”, but which is not written in a standard Markush-type claim format where the Markush-type claim should recite alternatives in a format such as "selected or chosen from the group consisting of A, B, and C." Alternatively, “selected or chosen from A, B or C” can be used. (see MPEP 2111.03 –II and 2117 and MPEP 2173.05(h)).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 35-37 and 50 are 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.
Each of claims 35-37 recites “the water soluble polymer” but which lacks sufficient antecedent basis because base claim 34 does not require “a water soluble polymer” but “a water insoluble polymer” instead. Appropriate correction is requested.
Claim 50 recites “autoimmune diseases, for example, type I diabetes, …” in line 5. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Specifically, claim 50 recites the broad recitation “autoimmune diseases”, and the claim also recites for example, type I diabetes, multiple sclerosis, rheumatoid arthritis …” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. Appropriate correction is requested.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 34-50 are rejected under 35 USC 103 as being obvious over Melnick et al. (WO2017/182237A1, IDS of 02/05/2025) in view of Chen et al., (US2008/0220079A1, IDS of 02/05/2025).
Applicant claims including the below claims 34, 42 and 47 filed on 05/15/2025:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a relevant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmacy, physiology and chemistry— without being told to do so.
Indeed, MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). This is because “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” (MPEP 2141.03(1)) and an artisan must be presumed to know something about the art apart from what the references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07). In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(11)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Melnick teaches a formulation containing solid oral dosage form and methods for treating vitamin D inefficiency in patients having CKD comprising administering an extended release dosage form of 25-hydroxyvitamin D, EUDRAGIT RS/RL system as a controlling agent, an emulsifier, an absorption enhancer, an oily vehicle such as castor oils, etc. ([0013], [0066] and [0068]); specifically in the dosage form using EUDRAGIT RL/RS system as a controlling agent, the active 25-hydroxyvitamin D ingredient is formed into granules having a dimension of 25/30 mesh which corresponds to 0.841mm/0.595mm that overlaps the instant range of about 0.2 to about 2.8mm, and thus the granule of prior art reads on the claimed pellets and the granules are then uniformly coated with a thin polymeric lacquer Eudragit RL/RS, which is water-insoluble but slowly water-permeable, and the coated granules can be mixed with optional additives including one or more of antioxidants, emulsifiers, absorption enhancers, stabilizers, binders, lubricants, processing aids and the like, and the mixture may be compacted into a tablet which, prior to use, is hard and dry and can be further coated, or it may be poured into a capsule ([0013], [0066], [0071], and [0077]) which reads on the solid oral dosage form and also teaches/suggests non-coating for pellets containing the said polymers and 25-hydroxyvitamin D, wherein the Eudragit RS/RL system is comprised of high permeability lacquers (RL) and low permeability lacquers (RS), RS is a water-insoluble film former based on neutral swellable methacrylic acids esters with a small proportion of trimethylammonioethyl methacrylate chlorides; RL is also a water insoluble swellable film former based on neutral methacrylic acid esters with a small portion of trimethylammonioethyl methacrylate chloride ([0078]), and thus, the Eudragit RS/RL reads on the claimed water insoluble polymer and ammonioalkyl methacrylate copolymer, and the binders and processing aids of Melnick also read on the claimed spheronizing agent as supported by instant publication ([0071] and [0191]: A24 – biner is spheronizing agent); although Melnick does not have pictures or diagrams showing a spherical shape of particle, granule or pellets, the prior art diameter to describe particle size would mean to an “spheronized” shape otherwise the claimed invention does not recite length x width x length dimensions of a rectangle particles, and it would also be obvious to provide the claimed dosage in the form of spheronized pellets in order to make larger spheres to hold more active agent. In addition, spheronized shape pellet is a matter of choice which a person of ordinary skill in the art would have found obvious. See MPEP 2144.04 B. Changes in Shape: In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). Further Melnick teaches the oral composition includes a lipophilic agent having an HLB of less than 7 such as mixed fatty acid monoglycerides; mixed fatty acid diglycerides; mixtures of fatty acid mono- and diglycerides, fatty acids and their soaps including stearic acid, palmitic acid, and oleic acid; and mixtures thereof glyceryl monooleate, glyceryl dioleate, glyceryl monostearate, glyceryl distearate, glyceryl monopalmitate, etc. ([0069]) which reads on the claimed lipophilic agent, and the oral composition further comprises an absorption enhancers such as polyglycolized glycerides or PEGylated glycerides having HLB of 13-18 ([0071]) which reads on the claimed hydrophilic agent, and thus the combination of lipophilic agent, absorption enhancer and extended release agent in the composition may reads on the claimed mixture (instant claims 34-35, 42 and 44-46); Melnick further teaches other water insoluble polymers include polyvinyl esters, polyvinyl acetals, polyacrylic acid esters, butadiene styrene copolymers and the like ([0079]); further Melnick teaches the dosage formulation comprises stabilizing agents to stabilize the dissolution release profile such as cellulosic compounds wherein the stabilizing agents include, but are not limited to, celluloronic acid, carboxy methyl cellulose, ethyl cellulose, hydroxyl ethyl cellulose, hydroxyl propyl cellulose, hydroxyl propyl methyl cellulose (hypromellose), methylcellulose, povidone (=polyvinylpyrrolidone), polyanionic cellulose, and combinations thereof in an amount of at least 5% or at least 10% ([0074]) in which when the cellulosic compound in the composition is used as the stabilizing agent, it would also act as an extended release polymer agent, in the absence of evidence to the contrary (instant claims 36 and 40); and although Melnick teaches PVP, PVP esters, PVP acetals as water insoluble polymers and PVP as noted above, Melnick does not expressly teach a blend of polyvinyl acetate and polyvinyl pyrrolidone of instant claim 37, and both ethyl cellulose and a blend of polyvinyl acetate of instant claim 40. However, it would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to modify the teachings of Melnick with a blend of polyvinyl acetate and polyvinyl pyrrolidine and/or ethyl cellulose. Since Melnick teaches ethyl cellulose as stabilizing agent and polyvinyl pyrrolidone, its ester and its acetal as a water insoluble polymer, replacing and/or modifying the ethyl cellulose or polyvinyl pyrrolidone, its ester or acetal of Melnick with either the blend of polyvinyl pyrrolidone and polyvinyl acetate, or with ethyl cellulose and the blend of polyvinyl pyrrolidone would be a matter of choice or design because those blended polymers would have had equivalent or additive functions in the absence of evidence to the contrary (instant claims 37 and 40). When the Eudragit polymer and/or cellulosic compound are used, the obtain granules or particles is free of hydrogen waxes (instant claim 38). Melnick further teaches method of treating vitamin D insufficiency in a patient having CKD or secondary hyperparathyroidism, cancer, type I diabetes, multiple sclerosis, rheumatoid arthritis, polymyositis, dermatomyositis, scleroderma, fibrosis, Grave’s disease, Hashimoto’s disease …acute chronic dermatitis comprising administering to the patient an oral extended release formulation of 25-hydroxyvitamin D ([0040] and claim 10 of prior art) and the treatment also comprises administering the formulation for supplementation of vitamin D ([0102]) (instant clams 47-50).
However, Melnick does not expressly teach extruded and spheronized pellets of instant claims 34, 42, and 47 and the amount of spheronizing agent instant claims 41 and 43. The deficiency is cured by Chen.
Chen discloses spherical pellet comprising an active agent, wax-like agent, and spheronizing agent wherein the spheronizing agent is microcrystalline cellulose in an amount of about 5 to about 40% (claims 1, 2, 4 of prior art) that overlaps the instant range of about 35 to about 60%. MPEP2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”, and the active agent includes vitamins A, B, C, D, E ([0098], [0315] and claim 13 of prior art), and wax-like agent is fatty alcohols, saturated and unsaturated fatty acid esters, saturated and unsaturated fatty acid glycerides, hydrogenated fats, hydrogenated vegetable oil, or cholesterol (claims 32-33 of prior art); the composition can be provided in the form of multiparticulates including powders, granules, pellets, microspheres, minispheres, beadlets, sachets etc., powders form oral suspension and sachets of an active ingredient ([0015] and [0152]); and the spherical pellets are made by mixing water, dry blend of the active ingredient, wax-like agent, spheronizing agent, and other optional ingredients and extruding the thus formed wet mass through a small orifice (typically approx. 1mm) and then extruded material is placed into a spheronizer to form round pellets ([0230]); and the pellets enables slow release of active ingredient due to relatively large sizes of pellets (e.g., at least about 0.5 mm or 1 mm in diameter for spherical pellets) ([0019]).
It would be obvious to modify the granules of Melnick with extruded and spheronized pellets of Chen and one of the ordinary artisans would have been motivated to do so because relatively large size of extruded pellets enables slow release of active ingredient, as taught by Chen.
In light of the foregoing, instant claims 34-50 are obvious over Melnick in view of Chen.
This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 34-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of patent no. 11,000,480B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require 25-hydroxylamin D compound, extended release agent including ethyl cellulose, spheronizing aid including microcrystalline cellulose, particle size of less than 1.0mm, and lipophilic agent including glyceryl behenate and polyglycolized. The difference between them is that patent ‘480 requires amounts of said ingredients, and however, the claimed invention uses “comprising”, which does not exclude the introduction of those amounts. Although patent ‘480 does not recite a method of treating as instantly claimed, since both instant claims and patent ‘480 require solid extended oral dosage forms noted above, thus, instantly claimed methods would be an obvious variation from patent ‘480.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘480 subject matter.
Claims 34-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of patent no. 12,433,842B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require 25-hydroxylamin D compound, extended release agent including ethyl cellulose and/or methyl cellulose, and spheronizing aid including microcrystalline cellulose, particle size of about 0.2 to about 2.8mm, lipophilic agent including glyceryl behenate and polyglycolized and a method treating a vitamin D responsive disease or condition. The difference between them is that patent ‘842 requires amounts of said ingredients, and however, the claimed invention uses “comprising”, which does not exclude the introduction of those amounts.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘842 subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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