DETAILED ACTION
The Office Action is in response to the Applicant's reply filed March 24, 2026 to the non-final rejection made on September 24, 2025.
Claims 50-57are currently pending and are examined on the merits herein.
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 .
Priority
This Application filed on 07/27/2022 is a 371 of PCT/NZ2021/050012 filed on 01/29/2021 which claims foreign priority to NEW ZEALAND 761251 filed on 01/29/2020.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
The rejection of claims 50-54 under 35 U.S.C. 102(a)(1) as being unpatentable over Tan et al. (WO2017131534A1) is not persuasive. The rejection is herewith maintained. Applicant argues “Anticipation requires disclosure of the claimed invention as a whole, not a mosaic of isolated teachings. While the Office identifies individual disclosures in Tan corresponding to each claim limitation.” It is Examiners contention that the genus taught by claim 6 and 8 of Tan et al. has substituents that are so small in number that one could readily envisage the claimed species.
The rejection of claims 50-57, under 35 U.S.C. 103(a) as being unpatentable over Tan et al. (WO2017131534A1) is not persuasive. The rejection is herewith maintained. Applicant argues “The disclosures of Tan amount to an invitation to further research the relationship of vascular anomalies to the RAS pathway, various therapeutic agents relating to the RAS pathway, and possible routes of delivery of said therapeutic agents.” “Further, Tan expressly acknowledges technical obstacles left unresolved. Page 23” Lastly, Applicant states “Tan is not self-enabling with respect to the claimed invention and therefore cannot, standing alone, establish a prima facie case of obviousness under 35 U.S.C. § 103. Accordingly, Applicant respectfully requests withdrawal of the rejection of claims 50-57.”
In response, the Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdiqital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results."). In this case, given that the prior art genus taught by claim 6 and 8 of Tan et al. has the identical substituents claimed, the claims are rendered obvious.
The rejections are as below:
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 50-54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan et al. (WO2017131534A1).
Tan et al. teaches methods of treating vascular anomalies, including venous malformation, pyrogenic granuloma (lobular capillary hemangioma) and infantile hemangioma, comprising administering to the patient a therapeutic agent (abstract; pg. 16, Il. 21-33; claim 6). Tan et al. teaches that suitable therapeutic agents are those that target the Renin-Angiotensin System (RAS) and include ACEis, B-blockers and ARBs (pg. 20, Il. 1-9; claim 8). Tan et al. teaches that suitable ACEis include captopril, benazepril, cilazapril, ramipril, trandolapril, enalapril and quinapril (pg. 20, Il. 10-14); suitable B-blockers include propranolol and timolol (pg. 20, Il. 17-23); and suitable ARBs include the ATITR2 antagonist PD123319 (pg. 20, Il. 15-16). Tan et al. teaches that the therapeutic agent may be administered by various routes, including topical and intradermal routes (i.e. local administration; pg. 26, Il. 12-18), as well as oral administration (i.e. systemic administration; pg. 26, ll. 12-18).
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.
Claims 50-57 are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (WO2017131534A1).
Tan et al. teaches methods of treating vascular anomalies, including venous malformation, pyrogenic granuloma (lobular capillary hemangioma) and infantile hemangioma, comprising administering to the patient a therapeutic agent (abstract; pg. 16, Il. 21-33; claim 6). Tan et al. teaches that suitable therapeutic agents are those that target the Renin-Angiotensin System (RAS) and include ACEis, B-blockers and ARBs (pg. 20, Il. 1-9; claim 8). Tan et al. teaches that suitable ACEis include captopril, benazepril, cilazapril, ramipril, trandolapril, enalapril, fosinopril and quinapril (pg. 20, Il. 10-14); suitable B-blockers include propranolol and timolol (pg. 20, Il. 17-23); and suitable ARBs include the ATITR2 antagonist PD123319 (pg. 20, Il. 15-16). Tan et al. teaches that the therapeutic agent may be administered by various routes, including topical and intradermal routes (i.e. local administration; pg. 26, Il. 12-18), as well as oral administration (i.e. systemic administration; pg. 26, ll. 12-18).
While the reference teaches the use of ACEis, B-blockers, the reference fails to specify the fosinopril and propranolol combination as recited in the claims.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate specifically a combination of fosinopril and propranolol. The motivation to incorporate a combination of fosinopril and propranolol is because the reference teaches treatment with each demonstrated efficacy in treatment of vascular anomalies. The skilled artisan would have reasonably concluded, in light of the shared efficacy in treatment of vascular anomolies, that the concomitant administration of fosinopril and propranolol would have been reasonably expected to achieve, at minimum, additive, if not synergistic, effects when combined. lt is further noted that in the absence of evidence to the contrary, it is generally prima facie obvious to use in combination two or more agents that have previously been used separately for the same purpose. See In re Kerkhoven, 205 USPQ 1069 (CCPA).
Reference of relevance: Zaher et al. (Propranolol versus captopril in the treatment of infantile hemangioma (IH): A randomized controlled trial. Journal of the American Academy of Dermatology Volume 74, Issue 3, March 2016, Pages 499-505).
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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 LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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, James Henry 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
Prosecution Insights