DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 01/07/2026, is acknowledged. Amendments to the specification have been entered.
Claims 1-5, 7-9, 11-12, 14-21, 23 are pending in this action. Claim 24 has been cancelled. Claims 6, 10, 13, 22 have been cancelled previously. Claims 1, 3-5, 7-9, 12, 14 have been amended. Claims 1-5, 7-9, 11-12, 14-21, 23 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application, filed October 17, 2023, is a 371 of PCT/CN2022/087994, filed Apryl 20, 2022, which claims benefit of foreign priority to CN202110423824.X, filed Apryl 20, 2021.
Claim Objections
Claims 5, 8-9, 19-21 are objected to because of the following informalities:
Claim 5 comprises the typographic error “he capsule according to claim 3” that needs to be corrected to “The capsule according to claim 3” or clarified.
The acronym “PVA” recited in claim 8 should be removed, because said acronym is not used in subsequent claims.
Claim 9 comprises the limitation “the film-forming agent” that needs to be corrected to “the second film-forming agent” for clarity.
Claim 19 comprises acronym “HIV”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed.
As stated previously, claim 20 comprises the limitation “the core is covered in the isolating layer” should be corrected to “the core is covered by the isolating layer” for clarity. Similar is applied to the limitation “layer is covered in the sustained release coating layer” as well as to claim 21.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3, 5, 12, 16 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 pre-AIA the applicant regards as the invention.
Newly amended claim 3 recites the limitation “the first film forming agent is selected from …. a polyvinyl polymer”. To this point, it is noted that neither the claims nor the instant specification teach/disclose the use of “polyvinyl polymer” in the disclosed capsules. As stated previously, the specification recites the term “polyvinyl-based polymer”, but does not provide the definition/clarification for said term, and further teaches the use of polyvinyl acetate phthalate as the 1st film-forming agent. Therefore, the scope of the claim is not reasonably clear. Clarification is required.
Newly amended claims 5 contains the limitation “methacrylic acid-methyl methacrylate copolymer (1:1)” that is unclear and indefinite. First, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). Second, the recited relative amounts, i.e., (1:1), are not clearly delineated, because they are shown without units of measurements (e.g., mol, wt, etc.). Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to other constituents recited in claim 5, as well as to claim 16. Clarification is required.
Newly amended claim 12 recites the limitation “a coating agent for the isolating layer” that is not reasonably clear. Is it an additional coating, OR a component of the isolating layer? This limitation was interpreted as best understood as “the isolating layer further comprises a coating agent comprising a mixture of”. Clarification is required.
Newly amended claim 12 recites the limitation “polyethylene glycol 3350” that is not reasonably, because the numerical index is not clearly delineated. Neither the claims nor the instant specification clarifies the structure of said polyethylene glycol to be used in the instant invention. This limitation was interpreted as best understood as “polyethylene glycol having an average molecular weight of 3350 g/mol”. Clarification is required.
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.
Claims 1-5, 7-9, 11-12, 14-21, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Fawzi et al., US 5,068,110A (cited in IDS; hereinafter referred to as Fawzi), in view OF Shimokawa et al., US 2019/0000768 A1 (cited in IDS; hereinafter referred to as Shimokawa), and further in view of Watts et al., CN 102088962A (cited in IDS; hereinafter referred to as Watts), and Zala et al., WO 2010/122574A2 (cited in IDS; hereinafter referred to as Zala).
Fawzi teaches stabilized enteric-coated pharmaceutical dosage forms that can be in a form of capsules comprising an active drug ingredient (e.g., antibiotics, steroids, procainamide), and wherein said capsules are sequentially coated with a precoat (i.e., an isolating layer) and an enteric coating (Col. 5, Lns. 23-32; Col. 6, Lns. 8-9; Col. 9, Ln. 30 -Col. 11, Ln. 10 as applied to claim 1, 2, 17-19).
Fawzi teaches that in said dosage forms the drug-containing substrates (that are sequentially coated) are preferably solid materials (Col. 5, Ln. 60 – Col. 6, Ln. 25 as applied to claim 1).
Fawzi teaches the use of: (i) a precoat comprising hydroxypropyl cellulose, or hydroxypropyl methylcellulose, and present in an amount of 4-6 mg/cm² (Abstract; Col. 5, Lns. 38-47; Table 5 as applied to claims 1, 8-9, 15); and (ii) an enteric coating layer that may include a combination of 24 g of Eudragit L30D, or cellulose acetate phthalate, or polyvinyl acetate phthalate, and 6 g of diethyl phthalate (Abstract; Col. 4, Lns. 36-68; Col. 6, Ln. 28- Col. 7, Ln. 12, Col. 9, Ln. 30 -Col. 11, Ln. 10 as applied to claims 1, 3-5).
Fawzi does not teach a precoat (i.e., an isolating layer) comprising at least one of sucrose, lactose, starch and mannitol (claim 1); does not teach the enteric coating layer comprising compounds as disclosed in claim 16; and/or the use of such active agents as budesonide or levodopa (claims 20, 21, 23).
Shimokawa teaches enteric capsules that are sequentially coated with a subcoating layer (i.e., an isolating layer) and an enteric coating layer (Abstract), wherein the subcoating layer includes 8.8 g of hydroxypropyl cellulose, and the enteric coating layer comprises 8.8 g of Eudragit L100, 0.9 g of triethyl citrate, and 4.4 g of talc (Para. 64-89, Table 3 as applied to claim 16). Shimokawa also teaches that the subcoating layer may include starch, sugar, e.g., sucrose, lactose, etc. (Para. 55 as applied to claim 1).
Watts teaches an enteric-coated capsule comprising budesonide, which can be used for treating Crohn's disease or ulcerative colitis and vascular glomerulonephritis (Para. 0038, 80-83; 0107-0111, Examples).
Zala teaches coated capsules comprising levodopa nucleus and a sustained-release coating layer tablet (Example 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try/use/include compounds as taught by Shimokawa into the enteric coating and/or isolated coating as taught by Fawzi, because it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. MPEP 2144.06. It also would have been obvious to try/use/include the active compounds as taught by Watts and Zala into the enteric coated capsules as taught by Fawzi. One would do so with expectation of beneficial results, because the cited prior art teaches enteric capsules sequentially coated with a subcoating layer (i.e., an isolating layer), having improved stability and/or providing the desired release and delivery of the incorporated active agent to a target location.
With regard to the concentrations as instantly claimed (claim 7), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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. Claims 11-12, 14 are rejected as being dependent on rejected independent claim.
Response to Arguments
Applicant's arguments, filed 01/07/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to applicant's arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In the present case,
All cited references are reasonably drawn to the same field of endeavor that is coated capsules comprising an active agent(s).
Fawzi and Shimokawa teach enteric-coated capsules comprising an active agent, wherein said capsules are coated with several layers, and wherein said layers may include compounds as instantly claimed.
Watts and Zala teach coated capsules that may include active agents as instantly claimed.
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been collectively taught by the combined teachings of the references. It is also noted that it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. MPEP 2144.06. One would do so with expectation of beneficial results, because the cited prior art teaches enteric capsules sequentially coated with a subcoating layer (i.e., an isolating layer), having improved stability and/or providing the desired release and delivery of the incorporated active agent to a target location.
To this point, it should be noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that: (i) The obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ; (ii) The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents; (iii) It is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed; (iv) It is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton); (v) It is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
In response to applicant’s argument that “not all combinations of the above components can achieve the advantageous technical effects”, i.e., the isolating layer containing Opadry II and the hydrophilic molecule sucrose can be used for providing fast dissolution of capsules and efficient drug absorbance in the intestinal tract, it is noted that the cited prior art teaches capsules that are substantially the same as the capsules recited by the instant claims, i.e., comprise components/compounds as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claimed language, the structure of the claimed capsules/layers and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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, Robert A. Wax can be reached at (571) 272-0623. 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.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights