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 .
Status of the Claims
Claims 1-27 as filed 7/23/2026 are pending in the application. Claims 18-27 are withdrawn with traverse. Claims 1-17, 23, and 24 are pending and under current examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/13/24 has been considered by the examiner.
Election/Restrictions, Response to Arguments
Applicant has correctly noted that the instant application is a continuation application subject to U.S. restriction practices. Accordingly, the previously issued requirement for restriction is withdrawn and newly presented as detailed below. Applicant’s election with traverse as in the reply dated 7/23/2026 is noted, however the requirement for restriction is not yet FINAL since it is newly presented herein. In the interest of compact prosecution, the claims elected with traverse are examined below.
Corrected Restriction Requirement
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a product which is a prednisone enteric-coated preparation comprising a prednisone micro-enteric-coated preparation unit as an active ingredient and a pharmaceutical adjuvant as an inactive ingredient, classifiable in A61K9/00.
II. Claims 18-22, drawn to a preparation method of making comprising steps of preparing, mixing, adding, subjecting, and adding as further specified in the claims, classifiable in A61K9/28.
III. Claims 25-28, drawn to a method of using a prednisone enteric-coating preparation for a certain use or population, classifiable in A61P11/06.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed can be used in a materially different process such as a process of making an anti-inflammatory agent product.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using the product such as in the synthesis of an alternative medicament product.
Inventions II and III are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions have different effects wherein the effect of the method of Group II results in a preparation of a product, opposed to the effect of the method of Group III, which results in the administration of a prednisone enteric-coated product to the particular use or population.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Multiple burdensome search queries spanning multiple classes and subclasses would be necessary to search all claimed inventions.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Election, Provisional
Regarding the reply as detailed above, the reply filed 7/23/2026 is considered a provisional election made with traverse to prosecute the invention of Group I, claims 1-17, 23, and 24. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-22 and 25-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 includes nonstandard abbreviations that do not constitute correct words or terms (see “a 2 h dissolution rate” and “a 30 min dissolution rate”, for instance). 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.
Claims 1-17, 23, and 24 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.
Claim 1 is drawn to “a prednisone enteric-coated preparation”, which is considered a “whole”, which comprises “prednisone micro-enteric-coated preparation unit as an active ingredient and a pharmaceutical adjuvant as an inactive ingredient”, which is considered a “part”. The structural and/or required relationship between the “preparation” of claim 1, line 1 and the “preparation” of claim 1, line 2 is unclear. Further, the preparation unit is subsequently said to comprise a specific range of prednisone and enteric polymer material (see claim 2). However, the relationship between the claimed preparation “whole” and preparation “part” is unclear since it is subject to variable subjective different interpretations. Are these the same or are these a part and a whole? How is the coating structured into the whole preparation vs. the part preparation? Limitations are not imported from the specification into the claim, and appropriate clarification is required. All claims depending from and/or otherwise requiring all limitations of claim 1 are rejected here.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 6, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN107106504A (Hanefeld et al; hereafter “Hanefeld”).
The instant claims are drawn to a preparation comprising a prednisone micro-enteric coated preparation unit as an active ingredient and a pharmaceutical adjuvant as an inactive ingredient, as further specified in dependent claims. The claims are interpreted as detailed in the specification as filed particularly at paragraph [0006] such that “micro” as recited in “micro-enteric-coated” as in claim 1 is considered to modify an active ingredient unit, for instance which is in the form of microspheres, and not a micro-scale enteric coating thereof.
Regarding claim 1, Hanefeld teaches preparations of enteric-coated microparticles comprising matrices of nanoparticles and an active ingredient (see abstract, in particular). Hanefeld’s active ingredient may be prednisone for instance (see last line of page 3 of translation).Hanefeld’s microparticles are contained in a colloidal dispersion coating material (see page 2, paragraph starting “The term “enteric coating”…”). Hanefeld’s formulations may be in the form of a suspension having a liquid component wherein water or an organic solvent may be included; said solvent is considered an adjuvant as an inactive ingredient (limitation of claims 1 and 6). Alternately, Hanefeld’s particles may include a cellulosic component which may be considered a filler and therefore an adjuvant inactive ingredient as claimed (see page 7 of translation, paragraph 6 for instance). Further regarding claims 23 and 24, Hanefeld’s products may be orally administered (see third paragraph of “Description” section of translation) and are considered capable of performing the intended uses further recited in these claims.
Accordingly, Hanefeld teaches each and every limitation of claims 1, 6, 23, and 24.
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.
Claims 1-6, 11, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over CN107106504A (Hanefeld et al; hereafter “Hanefeld”) in view of GB2502402 (Hiep et al.; “Hiep”).
The instant claims are drawn to a preparation comprising a prednisone micro-enteric coated preparation unit as an active ingredient and a pharmaceutical adjuvant as an inactive ingredient, as further specified in dependent claims. The claims are interpreted as detailed in the specification as filed particularly at paragraph [0006] such that “micro” as recited in “micro-enteric-coated” as in claim 1 is considered to modify an active ingredient unit, for instance which is in the form of microspheres, and not a micro-scale enteric coating thereof.
Regarding claim 1, Hanefeld teaches preparations of enteric-coated microparticles comprising matrices of nanoparticles and an active ingredient (see abstract, in particular). Hanefeld’s active ingredient may be prednisone for instance (see last line of page 3 of translation).Hanefeld’s microparticles are contained in a colloidal dispersion coating material (see page 2, paragraph starting “The term “enteric coating”…”). Hanefeld’s formulations may be in the form of a suspension having a liquid component wherein water or an organic solvent may be included; said solvent is considered an adjuvant as an inactive ingredient (limitation of claims 1 and 6). Alternately, Hanefeld’s particles may include a cellulosic component which may be considered a filler and therefore an adjuvant inactive ingredient as claimed (see page 7 of translation, paragraph 6 for instance). Further regarding claims 23 and 24, Hanefeld’s products may be orally administered (see third paragraph of “Description” section of translation) and are considered capable of performing the intended uses further recited in these claims.
Accordingly, Hanefeld teaches each and every limitation of claims 1, 6, 23, and 24. It is established that when a reference anticipates an invention, it necessarily renders such invention obvious as well. Anticipation is the “epitome of Obviousness”, In re Kalm, 378 F.2d 959, 962 (CCPA 1967).
Regarding claim 2, Hanefeld’s microparticles demonstrate an average size of 1 to 200 micrometers (see Hanefeld claim 12)(“microsphere” as in claim 2); the enteric polymer may be methacrylic acid copolymers (see page 7, paragraph 8)(limitation of claim 2); however, Hanefeld does not specify mass percentages of prednisone and enteric polymer material as in claims 2-4. It is noted that Hanefeld establishes hydrocortisone and prednisone alike as examples of active ingredients which may be used (see last line on page 3/11 of translation).
Hiep teaches pharmaceutical compositions adapted for oral administration comprising a core comprising hydrocortisone and a carrier and contacting the core a layer comprising a delayed release polymer which is a single or blend of enteric polymer providing delayed release of the active agent (see abstract, in particular). The enteric polymer is selected from acrylic acid and/or poly[methyl]acrylic polymers, cellulose acetate succinate, or polyvinyl acetate phthalate. Hiep specifies that in a preferred embodiment the hydrocortisone is provided at a final concentration of between 2-10% by weight of the composition (page 15, lines 11-14), a range overlapping the instantly claimed range of 10 to 50%. The enteric polymer is provided in an amount of 5-10% which appears to correspond to an enteric polymer as a coating layer on top of a prednisone-containing material. Please refer to the rejection above under 35 U.S.C. 112(b) regarding the metes and bounds of the preparation and preparation unit as in instant claims 1 and 2.
Neither Hanefeld nor Hiep teach the particular amount of prednisone and enteric polymer material ranges as recited in claims 2-4, however it is the examiner’s position that these amounts are result-effective variables that one would have been motivated to adjust to achieve the desired end result. For instance, one may be motivated to increase the amount of prednisone to increase the dosage and presence in a formulation and similarly may be motivated to increase the mass percentage of enteric coating polymer. One would have been motivated to do so in order to provide controlled and greater control over the release properties of the preparation product.
Further regarding claim 5, MPEP 2113 states that even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production, if the product in the product by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Moreover, “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).” Thus, it is applicant’s burden to provide evidence demonstrating the unobvious difference. It appears that Hanefeld and Hiep teach a preparation as claimed, and absent evidence to the contrary reasonably would be expected to have particle size, encapsulation rate, dissolution rate, and dissolution properties as claimed since a product and its properties are inseparable. Nevertheless, Hanefeld appears to teach solvent evaporation method of making in the middle of page 4/11 of translation in the paragraph starting (“In a typical spray drying machine…”).
Claims 7-10, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over CN107106504A (Hanefeld et al; hereafter “Hanefeld”) in view of GB2502402 (Hiep et al.; “Hiep”) as applied to claims 1-6, 11, 23, and 24 above, and further in view of US 2021/0236629A1 (“Nandi”).
The teachings of Hanefeld and Hiep have been delineated above. Neither of these teaches the list of adjuvant type components further detailed in claims 7, 11, and 14 and subsequent claims.
Nandi cures this deficiency. Nandi teaches dosage forms of allergenic extracts in oral pharmaceutical formulations for treatment of allergies for instance (see abstract, in particular). Nandi’s formulations may include enteric coating polymers, flavorants, preservatives, antioxidants, stabilizers, viscosity modifiers, gelling agents, sweeteners, vehicles, and similar formulation components (see [0021]) that represent the state of the art with regard to pharmaceutically acceptable excipients for controlled release capsule formulations for instance (see [0027] in particular).
Regarding the suspending agent component as in claims 7-9, Hanefeld teaches hydroxypropylmethylcellulose (hypromellose) may be used as an enteric coating material (see page 6/11 of translation, paragraph starting “The enteric coating material used…”), and Hiep teaches it may be included as a hydrophilic polymer in a preferred embodiment (see page 5, line 6) and demonstrates its functional equivalent in amounts between 1 and 6% (see Table 1). Nandi teaches xanthan gum and the hydroxymethyl cellulose to be equivalent as gelling agents which may be included in an amount of 40% or less (see [0133]). Nandi’s range includes the instantly recited ranges in claims 8-10.
Regarding the corrigent component, Nandi teaches sucralose and acesulfame K may be included as a sweetening agent in an amount of 30% or less or an amount of 3% or less for instance (see [0148]). Nandi embodies citric acid in an amount of 3% (see Table 5 on page 14 for instance).
Regarding the filler component, Hiep teaches fillers may be included (page 7, line 26) such as lactose (page 9, line 8). Hiep teaches microcrystalline cellulose to be included in an amount of 56.06% by weight (see Table 2)(limitation of claim 7, filler; limitation of claim 8, filler). Nandi teaches microcrystalline cellulose or lactose may be included as a filler type component (see [0142]) in an amount of 0.01-70% (see Table 4, page 13).
Regarding the fragrance component, Nandi teaches peach and peppermint among flavoring agents which may be used for example in an amount of 1% or less (see [0146]).
Further regarding claims 10, 12, and 13, Nandi demonstrates the active agent in Example 1 (see Table 1, [0155]) in an amount of 0.001-25% w/w with additional excipients further specified as in examples and ranges the same or substantially the same as outlined above.
Regarding the limitations of claim 14, the filler component is addressed above.
As to the disintegrant, Nandi teaches crospovidone to be included in an amount of 0.01-20% (see Table 4, item 4).
As to the binder which may be Hypromellose, this component is addressed above particularly regarding hypropmellose for instance and its amount.
As to the lubricant, Nandi teaches magnesium stearate in an amount of 0.01-3% (see Table 4, item 4).
Further regarding claim 16, Nandi teaches colloidal silicon dioxide may be included in an amount of 0.01-5%, croscarmellose sodium in an amount of 0.01-15% (see Table 4, items 4 and 5). As to the povidone K30, Nandi teaches polyvinylpyrrolidone (another name for the same thing) to be included as a gelling agent in an amount for instance 5% or less (see [0133]).
As to claim 17, all qualitative components have been addressed above, and the instantly claimed amounts are either anticipated by or obvious over the amounts suggested in the art as detailed above, since “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Hanefelt, Hiep, and Nandi are all directed to orally administered controlled release drug formulations comprising enteric polymer components. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to add the adjuvants including suspending agent, corrigent, filler, fragrance, disintegrant, binder, and/or lubricant as suggested qualitatively and quantitatively by Nandi to the formulations of Hanefeld and Hiep, with a reasonable expectation of success. One would have been motivated to do so to provide the functional benefits in the drug formulations including stability and controlled release parameters. Moreover, one would have found it prima facie obvious and been motivated to adjust the amounts of each respective functional component, with a reasonable expectation of success. One would have been motivated to do so to achieve the desired end result of both drug efficacy as well as formulation stability and controlled release optimization.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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