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
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 3/5/2026.
As filed, claims 1,15, 19-21, 27, 29, 46, 50, and 91-96 are pending, wherein claims 92-96 are new; claims 51-57, 69, 72, and 73 are withdrawn; and claims 2-14, 16-18, 22-26, 28, 30-45, 47-49, 58-68, 70, 71, and 74-90 are cancelled.
Election/Restrictions
Regarding the newly added claims 92-96, these claims are drawn to the elected invention of Group I and read on the elected species. Accordingly, these claims will be examined herein.
Because the Markush-type claims are determined to be free of prior art, the election of species requirement is hereby withdrawn.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 3/5/2026, with respect to claims 1, 2, 5, 15, 19-21, 27, 29, 46, 50, 74, 87, 90, and 91, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The objection to the specification is withdrawn per amendments.
The § 112(b) indefinite rejection of claims 27, 29, 46, 74, 87, 90, and 91 is withdrawn per amendments and cancellation of claims 74, 87, and 90.
The § 103(a) rejection of claims 1, 2, 5, 27, 29, 46, 50, 74, 87, 90, and 91 by Bova, as evidenced by Miglyol is withdrawn per amendments and cancellation of claims 2, 5, 74, 87, and 90.
The claim objection of claims 15 and 19-21 is withdrawn per amendment and further consideration by the Examiner.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 15, 27, 29, 46, 50, and 91-95 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment with respect to amended claims 1 and 29 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “5% to 25% weight/weight (w/w) proton pump inhibitor” for the instant injectable pharmaceutical formulation, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 1/13/2022) only provide support for 15% to 25% weight/weight (w/w) proton pump inhibitor.
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(paragraph 0054 of the instant specification)
Accordingly, the w/w of the proton pump inhibitor outside of 15% to 25% is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claims 1 and 29 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “is stable for at least 6 months” for the instant injectable pharmaceutical formulation, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 1/13/2022) only provide support for the instant formulation to be stable after 6 months at either 25oC or 30oC or to be stable for 6-12 months at both 2-8oC and 25oC.
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(paragraph 00113 of the instant specification)
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(paragraph 00123 of the instant specification)
Accordingly, the stability of the instant injectable pharmaceutical formulation outside the temperature of either 25oC or 30oC or the stability of the instant injectable pharmaceutical formulation outside of 12 months and outside of either 2-8oC or 25oC is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claims 1 and 29 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “or a combination thereof” for the species of instant proton pump inhibitor, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 1/13/2022) only provide support for a combination of ingredients in the instant injectable pharmaceutical formulation, such as proton pump inhibitor, plant oils, caprylic/capric triglycerides, preservative, etc.
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(paragraph 0066 of the instant specification)
Accordingly, a combination of the species of the instant proton pump inhibitor (e.g. a combination of omeprazole, esomeprazole, etc.) in the instant injectable pharmaceutical formulation is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Regarding claims 15, 27, 50, 91, and 95, these claims are dependent of claim 1, and they failed to correct the defective issue in claim 1, which rendered these claims improper.
Regarding claim 46, this claim is dependent of claim 29, and it failed to correct the defective issue in claim 29, which rendered the claim improper.
Applicant’s amendment with respect to amended claims 92 and 94 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “a combination of two or more thereof” for the species of instant proton pump inhibitor, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 1/13/2022) only provide support for a combination of ingredients in the instant injectable pharmaceutical formulation, such as proton pump inhibitor, plant oils, caprylic/capric triglycerides, preservative, etc.
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(paragraph 0066 of the instant specification)
Accordingly, a combination of the species of the instant proton pump inhibitor (e.g. a combination of omeprazole, esomeprazole, etc.) in the instant injectable pharmaceutical formulation is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Regarding claim 93, the claim is dependent of claim 92, and it failed to correct the defective issue in claim 92, which rendered the claim improper.
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, 15, 27, 29, 46, 50, 91, and 95 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.
Regarding claims 1 and 29, it is unclear to the Examiner what constitute as “stable” for the instant injectable pharmaceutical formulation. There is no indication what constitutes “stable” is recited or discussed in the specification. There could be chemical stability, etc. Accordingly, the claims are rendered indefinite.
Regarding claims 15, 27, 50, 91, and 95 these claims are dependent of claim 1, and they failed to correct the indefiniteness issue in claim 1, which rendered these claims improper.
Regarding claim 46, this claim is dependent of claim 29, and it failed to correct the indefiniteness issue in claim 29, which rendered the claim improper.
Claim Objections
Claims 15, 27, 46, and 92 are objected to because of the following informalities:
Regarding claim 15, the claim recites the phrase, “esomeprazole magnesium dihydrate, and a combination of two or more thereof”, which contains typographical error.
Such typographical error can be corrected by reciting – and esomeprazole magnesium dihydrate
Regarding claims 27 and 46, the claims recite the phrase “other livestock animal”, which contains typographical error.
Such typographical error can be corrected by reciting –
Regarding claims 46 and 92, the claims recite the phrase, “sodium bisulfite, and a mixture of two or more thereof”, which contains typographical error.
Such typographical error can be corrected by reciting – sodium bisulfite, and a mixture --.
Appropriate correction is required.
Allowable Subject Matter
Claims 19-21 and 96 are allowed.
Conclusion
Claims 1, 15, 27, 29, 46, 50, and 91-95 are rejected.
Claims 19-21 and 96 are allowed.
Claims 15, 27, 46, and 92 are objected.
Claims 51-57, 69, 72, and 73 are withdrawn.
Claims 2-14, 16-18, 22-26, 28, 30-45, 47-49, 58-68, 70, 71, and 74-90 are cancelled.
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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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