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
Applicant’s response dated 18 August 2025 to the previous Office action dated 20 May 2025 is acknowledged. Pursuant to amendments therein, claims 44, 46, 50-54, 58-63, and 65-69 are pending.
The rejections under 35 U.S.C. 112 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but new rejections under 35 U.S.C. 112 are made herein in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 102 and 103 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but a new rejection is made herein under 35 U.S.C. 103 in view of applicant’s claim amendments.
The double patenting rejections made in the previous Office action are withdrawn in view of applicant’s claim amendments.
Election/Restrictions
Claims 62-63 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07 May 2025.
Claims 44, 46, 50-54, 58-61, and 65-69 are under current consideration.
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 66 and 69 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.
Claims 66 and 69 recite microcrystalline cellulose MCC with designation 101QD, but there is no indication in the specification and drawings as to what such designation means, nor does such designation appear to be well-known in the art, thus rendering the claims indefinite.
Claims 66 and 69 contain the trademark/trade name OPADRY 85F. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an isolation layer component and, accordingly, the identification/description is indefinite.
Claim 69 recites methacrylic acid-ethyl acrylate copolymer with designation L100-55, but there is no indication in the specification and drawings as to what such designation means, nor does such designation appear to be well-known in the art, thus rendering the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 50-54 and 60-61 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claims 50-54 and 60 do not contain a reference to a claim previously set forth, but rather contain a reference to a subsequent claim, claim 67. Claim 61 is rejected as depending upon rejected claim 60 without remedying such deficiency.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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) 44, 46, 50-54, 58-59, 65, and 67-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhargava et al. (US 2017/0119627 A1; published 04 May 2017).
Bhargava et al. discloses extended release suspension compositions (title) with immediate release coating of active ingredient (i.e., immediate-release layer, immediate-release part) over extended release coated cores (i.e., sustained-release part) (paragraph [0109]) wherein cores may comprise a release-controlling agent in the form of a matrix with the active ingredient, which can be coated with a coating layer (i.e., a controlled-release film) (paragraph [0086]) over the core comprising release-controlling agents (paragraph [0087]) wherein the active ingredient may be oseltamivir (claim 19; paragraph [0108]) wherein release-controlling agents (i.e., sustained release materials) may comprise a pH-dependent release-controlling agent and/or a pH-independent release-controlling agent (paragraphs [0091], [0110]) wherein pH-dependent release-controlling agents may be HPMC acetate succinate and/or methacrylic acid - ethyl acrylate copolymer (paragraph [0111]) wherein pH-independent release-controlling agents may be HPMC (paragraph [0112]) wherein 27% of the active ingredient is released after 1 hour, 83% of the active ingredient is released after 4 hours, and 93% of the active ingredient is released after 10 hours (Table 1).
Although Bhargava et al. does not disclose an exemplary composition containing oseltamivir having such structure and release characteristics as discussed above, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bhargava et al. as discussed above and to make a composition containing oseltamivir having such structure and release characteristics as discussed above, with a reasonable expectations of success.
Although Bhargava et al. does not disclose a concentration of oseltamivir as claimed, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize pharmaceutical effectiveness and once-daily dosage convenience of the composition of Bhargava et al. by varying the concentration of oseltamivir active ingredient in the core thereof through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success.
Although Bhargava et al. does not disclose a concentration of sustained-release material as claimed, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize release time of the active ingredient of the composition of Bhargava et al. by varying the concentration of release-controlling agents (i.e., sustained-release material) in the core thereof through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success.
Furthermore regarding the claimed recitation of “the formulation is effective at a once-daily dosage to a patient in need thereof”, such recitation is merely an intended use recitation and imposes no further structure/limitation on the claimed formulation.
Regarding claims 46 and 50-52, although Bhargava et al. does not disclose such dosages as claimed, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize active ingredient oseltamivir effectiveness and dosages of the composition of Bhargava et al. by varying the concentrations and amounts and dosages of oseltamivir active ingredient in the core and immediate-release coating thereof through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that drug concentration/amount/dosage is a well-known result-effective variable. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Regarding claims 51-54, and 58, although Bhargava et al. does not disclose such claimed properties, the composition of Bhargava et al. as discussed above is presumed to inherently exhibit such properties per MPEP 2112(V) and 2112.01(I) given that the composition of Bhargava et al. as discussed above is at least substantially identical to the claimed composition, and given that identical compositions necessarily have the same properties per MPEP 2112.01(II).
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 made in the previous Office action have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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