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
The preliminary amendment filed 01/06/2025, cancelled claims 2-5, 10, 14, 18-21, 24, 26-28, 30, 32, 34, 36, and 38.
Claims 1, 6-9, 11-13, 15-17, 22-23, 25, 29, 31, 33, 35, 37, and 39-40 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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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 6-7, 29, 31, 33 and 35 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.
In claims 6-7, 29, 31, 33, and 35, the phrase “Method III (Cone-and-Plate Rheometers) described in USP <912>” renders the claims indefinite. Since the United States Pharmacopeia National Formulary is continually revised, i.e., three times per year, it is not clear what standard of “Method III (Cone-and-Plate Rheometers) described in USP <912>” is being referenced and adhered to, in order to achieve the instantly claimed viscosity measurements.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 9, 11-13, 15-17, 22-23, 25, 37, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Translation of WO 2016/178,053 to Lozinsky (published 2016, TRANSLATION, PTO-892) in view of Drugs.com (Tranexamic Acid Dosage, published 2021, PTO-892), as evidenced by IMCD (Natrosol 250 HHX, published 2026, PTO-892).
Lozinsky teaches compositions for the treatment of epistaxis (title, pg. 4).
Lozinksy exemplifies a gel composition comprising about 10% tranexamic acid, about 0.6% hydroxyethylcellulose (Natrosol HHX), and water (pg. 21).
Lozinsky differs from instant claim 1 in that it does not teach the concentration of tranexamic acid.
Drugs teaches tranexamic acid dosages for use in bleeding (title; pg. 1).
Drugs teaches a range of dosages based on the age of the patient, the disorder being treated, and renal function, such as 10mg/kg infused at 1mL/minute and 3900mg/day (pgs. 2-3).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select about 250mg/mL to about 300mg/mL as the concentration of tranexamic acid in the compositions of Lozinsky, to arrive at the instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Lozinsky teaches its compositions for the treatment of a bleeding disorder (i.e., epistaxis),
-Drugs teaches that tranexamic acid can be administered in a range of dosages based on the age of the patient, the disorder being treated, and the patient’s renal function, to treat bleeding disorders, and
-"[W]here 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," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a an aqueous tranexamic acid composition that it optimized to stop or inhibit epistaxis.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 9, Lozinsky teaches 0.6% hydroxyethylcellulose.
Regarding claims 11-13, as evidenced by IMCD, Natrosol HHX has a viscosity range of 3400-5000cps, and "[W]here 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," MPEP 2144.05(II).
Regarding claim 15, Lozinsky teaches that its composition may further comprise a buffer (pg. 21).
Regarding claim 16, Lozinksky teaches that the pH buffer can be a citrate buffer (pg. 8).
Regarding claim 17, though Lozinsky does not teach the concentration of citrate buffer, an ordinary skilled artisan would have been motivated to modify the concentration to predictably arrive at a concentration that is effective to stabilize the composition and be safely administered to a patient with epistaxis; "[W]here 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," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 22-23 and 25, Lozinsky teaches its compositions as having a pH of about 3.5 to about 5; in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, MPEP 2144.05.
Regarding claim 37, Lozinsky teaches its compositions as sterile (pg. 24).
Regarding claim 39, Lozinsky teaches kits comprising a container (pg. 2, claim 18).
Regarding claim 40, while Lozinsky does not teach the volume of the composition of the kit, Lozinsky teaches its kits as single-use. As such, an ordinary skilled artisan would have been motivated to modify the volume of the kit to predictably arrive at a volume that is optimized for a single use application to treat epistaxis.
Claims 6-8, 29, 31, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/178,053 to Lozinsky (published 2016, TRANSLATION, PTO-892) in view of Drugs.com (Tranexamic Acid Dosage, published 2021, PTO-892), as evidenced by IMCD (Natrosol 250 HHX, published 2026, PTO-892), as applied to claims 1, 9, 11-13, 15-17, 22-23, 25, 37, and 39-40, and further in view of Hapgood (Hydroxyethyl Cellulose, published 2009, PTO-892).
Lozinsky and Drugs are applied as discussed above and incorporated herein.
Regarding claims 6-7, 29, 31, 33, and 35, the composition of Lozinsky and Drugs differs in that it does not teach the viscosity of the composition.
Hapgood teaches hydroxyethyl cellulose as a nonionic, water-soluble polymer widely used in topical cosmetic formulations (pg. 311, Cols. 1-2).
Hapgood teaches that hydroxyethyl cellulose is available in a wide range of viscosity types and grades, wherein the grades differ principally in their aqueous solution viscosities which range from 2-20,000mPa s for a 2% w/v aqueous solution. Aqueous solutions made using a rapidly dispersing material may be prepared by dispersing the hydroxethyl cellulose in mildly agitated water at 20-25 C. Complete dispersion may be achieved by controlling the temperature, pH, and rate of stirring (pg. 311, Col. 2). Increasing the temperature reduces the viscosity of aqueous hydroxyethyl cellulose solutions (pg. 312, Col. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the viscosity of the hydroxyethyl cellulose, to arrive at a composition with 1-50 cps, measured at 21 C using the rotational viscosity Method III (Cone-and-Plate Rheometers described in <912>. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because Hapgood teaches that it is known in the art to modify the viscosity of hydroxyethyl cellulose, and hence the viscosity of compositions comprising the hydroxyethyl cellulose, in pharmaceutical formulations.
As such, an ordinary skilled artisan would have been motivated to make such modifications to predictably arrive at a formulation that is optimized for viscosity and hence spreadability and ease of application.
Regarding claim 8, an ordinary skilled artisan would have been motivated to modify the concentration of the hydroxyethyl cellulose to about 1mg/mL to about 2 mg/mL, to predictably arrive at a concentration optimized to achieve a enhanced spreadability and ease of application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-9, 11-13, 15-17, 22-23, 25, 29, 31, 33, 35, 37, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,642,324 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 6-7, 8-11, 22-23, 25, 29, 31, 33, and 35, ‘234 claims:
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(claim 1).
Regarding claim 8, see claim 4 of ‘234.
Regarding claims 15-16, see claims 7-8 of ‘234.
Regarding claim 37, see claims 22-25.
Regarding claims 39-40, see claims 17-19 of ‘234.
Regarding claims 9 and 17, an ordinary skilled artisan would have been motivated to modify the % weight of the hydroxyethyl cellulose and/or the concentration of the citrate buffer, to predictably arrive at a formulation wherein the viscosity of the hydroxyethyl cellulose is 300-6500cps and the viscosity of the composition is 1-50 cps, and/or wherein the pH of the composition is about 3 to 5. "[W]here 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." MPEP 2144.05(II)
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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