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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/15/2026 has been entered.
Status of Application
The response filed 05/15/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 7-8, 12-13, 15-16, 19, 21 have been amended.
Claims 2-6, 14 are cancelled.
Applicant had previously elected Group I, claims 18-19 and 21 are withdrawn being drawn to a non-elected invention.
Claims 1, 7-13, 15-19 and 21 are pending.
Claims 1, 7-13, 15-17 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant had previously made the statement that the previously presented Luo (WO 2020/011254) which is also its national stage application of U.S. Pat. Pub. 2021/0323960 and was used as the translation of the WIPO document, along with the instant application were both subject to an obligation of assignment to Chia Tai Tianquing Pharmaceutical Group Co. Ltd. no later than the effective filing date of the claimed invention; wherein Luo does not qualify as prior art under 102(a)(2).
Applicant had submitted an English translation of the certified priority documents along with a statement that the translation of the certified copy is accurate wherein the effective filing date of the claimed invention is 01/15/2020 wherein Luo et al. does not qualify as prior art under 102(a)(1) and Yao et al. (WO 2021/143843) no longer qualifies as prior art under 102(a)(2).
The claims as amended recite specific excipients and formulations which no longer reads on claims from U.S. Patent No. 11993596 or copending Application No. 17792192 as a basis for double patenting, wherein the double patenting rejections are withdrawn as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
Priority
Applicant has submitted an English translation of the certified priority documents along with a statement that the translation of the certified copy is accurate wherein the effective filing date of the claimed invention is now 01/15/2020.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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 8-11 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.
The claims are unclear as they are dependent from cancelled claims.
Claim 8 depends from claim 3 which is cancelled.
Claim 9 depends from claim 4 which is cancelled.
Claim 10 depends from claim 2 which is cancelled.
Claim 11 depends from claim 5 which is cancelled.
It does not allow one to ascertain the metes and bounds of the claims as written.
For purposes of examination, it is treated to be from claim 1.
Claim 8 is 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.
The claim as written recites three different Markush groups for the buffer which have the same or genus/species groupings which are broad and narrow groupings (i.e. the first Markush group recites sodium citrate and a sodium tartrate and disodium hydrogen phosphate; while the second Markush grouping for the buffer recites a citrate, a tartrate, and a phosphate which are present in the first grouping; and the third Markush grouping recites a citrate and tartrate and a phosphate which is present in the other two grouping; wherein it is unclear what the metes and bounds are of the claims as written.
Additionally, the claim recites for the alternative or the buffering agent being used to control a pH of the pharmaceutical composition between about 3.0 and about 8.5, which is confusing as the nature of the buffer to control the pH at a particular range wherein it is unclear how it is an alternative verses a definitive i.e. wherein the buffer maintains a pH of about 3.0-about 8.5. For purposes of examination the claim is treated to be any combination of buffers to maintain the pH of the composition at about 3.0-about 8.5.
Claim 12 is 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 12 recites the limitation of "the buffering agent having a concentration of 0.1mg/mL to about 25 mg/mL" in claim 1 from which it depends. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites the buffer to have a concentration of 0.5 mg/mL to about 6 mg/mL wherein the amount of buffer recited in claim 12 is broader than the claim is depends from and does not have antecedent basis wherein it does not allow one to ascertain the metes and bounds of the claims as written.
Claim 13 is 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 13 recites the limitation of "the buffering agent having a concentration of 0.1mg/mL to about 25 mg/mL" in claim 1 from which it depends. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites the buffer to have a concentration of 0.5 mg/mL to about 6 mg/mL wherein the amount of buffer recited in claim 13 is broader than the claim is depends from and does not have antecedent basis wherein it does not allow one to ascertain the metes and bounds of the claims as written.
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.
Claim 12 is 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 12 recites the limitation of "the buffering agent having a concentration of 0.1mg/mL to about 25 mg/mL" and depends from claim 1 which recites the buffer to have a concentration of 0.5 mg/mL to about 6 mg/mL wherein the buffer range in claim 12 is broader than the claim is depends from and does not further limit the claim.
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 13 is 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 13 recites the limitation of "the buffering agent having a concentration of 0.1mg/mL to about 25 mg/mL" and depends from claim 1 which recites the buffer to have a concentration of 0.5 mg/mL to about 6 mg/mL wherein the buffer range in claim 12 is broader than the claim is depends from and does not further limit the claim.
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.
Status of Claims with Regards to Prior Art
The claims are free of the prior art but claims 8-13 are subject to the 112 rejections above.
Claims 1, 7, 15-17 are allowed
Conclusion
Claims 8-13 are rejected.
Claims 1, 7, 15-17 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/ Primary Examiner, Art Unit 1613
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