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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 18, 2025, that includes a response to the Final Office Action mailed August 19, 2025, has been entered. Claims 1, 3, and 14 have been amended; and claims 2 and 5 have been canceled. Claims 7, 10, 11, 15, and 16 have been withdrawn. Claims 1, 3, 4, 6, 8, 9, and 12-14 are currently under examination in the application.
Withdrawal of Prior Claim Rejections - 35 USC § 103
Neither Van Meeteren et al. (U.S. Patent Application Pub. No. 2007/0270459), Bao et al. (Chinese Patent Application No. CN 106562968), Branco et al. (U.S. Patent No. 4,576,646), nor Anonymous (Ataman Chemicals [online]; 2015) disclose or reasonably suggest a composition in the form of particles acting as a separate dosage form, each of which comprises all of a modified-release layer comprising tamsulosin, diluents, and modified-release polymers; a first seal coat comprising Hypromellose 5 cps; a sustained-release coating comprising modified-release polymers; a second seal coat comprising Hypromellose 5 cps and antioxidants; an immediate-release outer layer comprising solifenacin, Hypromellose 5 cps, and antioxidants; and one or more protective layers comprising Hypromellose 5 cps and antioxidants. Therefore, the 35 USC 103 rejection presented in the Final Office Action mailed august 19, 2025 is hereby withdrawn.
Claim Objections
Claim 1 is objected to because of the following:
i). Claim 1 contains two c) elements, one after b), and another after f). Since the c) element after f) appears to be blank, Applicant is advised to delete the second c).
ii) In claim 1, a) and c), the term “modified release polymers” should have a hyphen between “modified” and “release”.
iii). In claim 1, c) and d), the term “sustained release coating” should have a hyphen between “sustained” and “release”.
iv) In claim 1, c), there is an extraneous “the” between “comprises” and “modified release”.
v) In claim 1, d), which is directed to the second seal coat, reference to “the first seal coat” in the wherein clause appears to be a typographical error for “the second seal coat”.
vi) In claim 1, f), there is an extraneous dash between “more” and “protective”. There is a missing “an” between “5 cps” and “antioxidant”.
vii) In claim 1, there should be an “and” between elements e) and f). Further, there should be a semicolon after element f) and before “wherein the composition is”. Currently, there is an extraneous “and” after element f) and before “wherein the composition is” that should be deleted.
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 1, 3, 4, 6, 8, 9, and 12-14 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 indefinite for the following reasons:
1. Claim 1, c), which addresses a sustained-release coating, makes reference to “the modified release polymers”. There is insufficient antecedent basis for any modified release polymers in the sustained-release coating. It is noted that in element a), the inner layer requires modified-release polymers, but one of ordinary skill in the art would not understand how the modified-release polymers contained in the inner layer would also simultaneously be present in the sustained-release coating. Moreover, one of ordinary skill in the art cannot definitively ascertain whether the modified-release polymers in the sustained-release coating are necessarily precisely the very same type of polymer that is also present in the inner layer.
2. Claim 1, d) introduces the second seal coat, but then stipulates in a wherein clause that “the first seal coat” comprises Hypromellose 5 cps and antioxidants. However, the first seal coat is addressed in b), and is said to contain merely Hypromellose 5 cps, but antioxidants are not mentioned. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
3. Claim 1, in e.g. d) and e), stipulates that the composition contains “antioxidants”, while for f) “an antioxidant” is specified. One of ordinary skill in the art cannot definitively ascertain if e.g. d) and e) require two or more antioxidants, while f) requires only one, or whether “an antioxidant” and “antioxidants” are interchangeablew to mean one or more antioxidants.
4. Claim 1 first specifies that the composition is “a plurality” of particles, but then in the wherein clause stipulates that the composition is “a single pellet”. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
5. Claim 1 stipulates in a wherein clause that “each” of the particles has “an average particle diameter ranging from 20 to 1200 µm”. One of ordinary skill in the art would generally understand that any one individual particle itself will have one specific diameter, not an “average diameter” that ranges between 20 to 1200 µm. One of ordinary skill in the art thus cannot definitively ascertain whether each individual particle has a dynamic variable diameter that fluctuates over time, such that there is an average diameter of 20 to 1200 µm, or what?
Claim 3, which depends from claim 1, stipulates in a wherein clause that the composition is in the form of a granule or an extrudate. However, claim 1 expressly stipulates that the composition is in the form of a pellet. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 6, 8, and 12 depend from claim 5, which is canceled. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 3, 4, 6, 8, 9, and 12-14 are (also) indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 112(d)
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 3 and 4 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.
Claim 3, which depends from claim 1, stipulates in a wherein clause that the composition is in the form of a granule or an extrudate. Claim 1, however, appears to require that the composition is in the form of a pellet. Claim 3, therefore, appears to be broader in scope than claim 1 from which it depends.
Claim 4, which depends from claim 1, stipulates in a wherein clause that the composition is in the form of a pellet. Claim 1, however, appears to already require that the composition is in the form of a pellet. Claim 4, therefore, does not appear to further limit claim 1 from which it depends.
Potential Future Rejoinder of Claims
While claims 10 and 11 remain withdrawn at this time, in the event claim 1 is put into condition for allowance, Applicant may want to rejoin claims 10 and 11. However, Applicant is first advised that claim 11, which depends from claim 1, suffers from issues under 35 USC 112, since the composition of claim 1 is a pellet that acts as a dosage form in itself. Moreover, in order to rejoin claim 10, this claim must depend from or include all the limitations of claim 1. Indeed, Applicant is advised to not only make claim 10 a process of making the composition of claim 1, but to include a complete set of active steps for producing the composition of claim 1, with elements a)-f).
Conclusion
No claims are allowed.
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/DAVID BROWE/Primary Examiner, Art Unit 1617