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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 8, 2026 has been entered.
Detailed Action
This office action is a response to applicant’s communication submitted September 8, 2026, wherein claim 1 is amended. This application is a continuation of US application 17/284071, now US patent 11752169, filed April 9, 2021, which is a national stage application of PCT/AU2019/051094, filed October 10, 2019, which claims priority to foreign applications AU2018903820, filed October 10, 2018, AU2019900326, filed February 4, 2019, and AU0219903556, filed September 24, 2019.
Claims 1, 23, 24, 26-28, and 37 are pending in this application.
Claims 1, 23, 24, 26-28, and 37 as amended are examined on the merits herein.
Priority
Applicant's claim for foreign priority to applications AU2018903820, AU2019900326, and AU2019903556 is acknowledged. However, the claims as currently pending do not find support in these priority documents. The presently pending claims are directed to a method of treating pain associated with multiple sclerosis in a mammal, comprising administering an effective amount of pentosan polysulfate to the mammal. While the priority documents generally describe the treatment of pain using pentosan polysulfate, none of the cited foreign priority applications describe methods of treating pain associated with multiple sclerosis. Therefore these documents fail to provide written description for the present claims under 35 USC 112(a). The effective filing date of all presently pending claims is seen to be the international filing date of PCT/AU2019/051094, filed October 10, 2019.
Withdrawn Rejections
Applicant’s arguments, submitted September 8, 2026, with respect to the rejection of claims 1, 23, 24, 26-28, and 37 under 35 USC 103 for being obvious over Parsons et al. in view of Frohbergh et al., has been fully considered and found to be persuasive to remove the rejection as it is unclear whether the prior art method described by Parsons functions by inhibiting NGF. Therefore the rejection is withdrawn.
The following new grounds of rejection are introduced:
Claim Rejections - 35 USC § 102
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.
Claims 1, 23, 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlo. (US pre-grant publication 2019/0358209, cited in PTO-892)
Independent claim 1 is directed to a method for treating pain associated with multiple sclerosis comprising administering to a mammal an effective amount of a pentosan polysulfate, by intramuscular, subcutaneous, intraventricular, intracisternal, intrathecal, intravenous, or topical administration. The claim further specifies that the treatment works by inhibiting or reducing nerve growth factor. (NGF)
Carlo discloses pharmaceutical compositions for treating pain in a mammal, wherein multiple sclerosis is specifically enumerated as one possible cause of the pain being treated. (p. 1 paragraphs 15-16) The therapeutic agent being administered is a composition comprising several ingredients, one of which is a heparin-lie compound. (p. 2 paragraph 21) In a preferred embodiment the heparin-like compound is pentosan polysulfate sodium. (p. 3 paragraphs 41-42) The composition can furthermore be formulated for local or systemic injection. Systemic injection would reasonably be one of intramuscular, subcutaneous, or intravenous administration as recited in present claim 1 and local injection (to the central nervous system) for treating multiple sclerosis would necessarily involve what could be considered topical, intraventricular, or intrathecal injection.
Furthermore while Carlo does not specifically describe a method wherein the pentosan polysulfate sodium acts by inhibiting nerve growth factor, it is reasonably expected that a method involving administering the same composition to the same subject by the same route (i.e. systemic or local injection of sodium PPS to a mammal suffering from multiple sclerosis) would result in the same outcome, namely reducing or inhibiting NGF activity in the subject. Therefore claims 1, 23, and 24 are anticipated by Carlo.
Claim Rejections - 35 USC § 103
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 1, 23, 24, 26-28, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Carlo. (US pre-grant publication 2019/0358209, cited in PTO-892) in view of Frohberg et al. (Reference of record in previous action)
The disclosure of Carlo is discussed above. While as discussed previously, it is concluded that local or systemic injection of sodium PPS for treating multiple sclerosis would necessarily require administration by one of the routes described in claim 1, even assuming for the sake of argument that this is not automatically the case, administration by one of the claimed routes would have been obvious further in view of Frohberg et al.
Frohbergh et al. discloses that while sodium PPS has been used as an oral therapy for interstitial cystitis, injectable forms have greater bioavailability. (p. 2 right column) Both oral and subcutaneous administration exerted anti-inflammatory effects. (p. 3 left column last paragraph, p. 8 right column last paragraph) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer NaPPS subcutaneously to subjects suffering from multiple sclerosis as described by Parsons et al. One of ordinary skill in the art would have recognized based on Frohbergh et al. that subcutaneous administration are methods of systemic injection of PPS that could be used to treat inflammatory diseases. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use subcutaneous injection as a form of systemic injection in the methods described by Carlo.
Regarding claims 26-28, Carlo discloses administering the heparin-like compound, such as pentosan polysulfate, in various doses between 50-200 mg. (p. 2 paragraph 33, p. 3 paragraph 45) Taken as a whole, an administration of 50-200 mg to a human would overlap substantially with the range of 1-2 mg/kg recited in claim 26. Carlo further discloses administering in between 1 and 6 times daily, (p. 3 paragraph 46) which includes once daily administration. Regarding claim 28, this claim appears to refer to the total dose of NaPPS administered across multiple doses over the whole duration of treatment. Based on this guidance one of ordinary skill in the art would have been able to reasonably determine the appropriate dosage of PPS to administer, treating the dose as a result effective variable.
For these reasons the invention taken as a whole is prima facie obvious.
Response to Arguments
Applicant’s arguments, submitted September 8, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejections. Applicant’s arguments depend on the assertion that the previously cited reference Parsons et al. WO2015/127416 only describes oral administration of sodium PPS, and furthermore that oral administration of sodium PPS does not inhibit NGF activity. However, as discussed in the body of the rejections, the reference Carlo does already describe systemic injection (e.g. subcutaneous) of sodium PPS. Therefore it is reasonable to conclude that it functions in the same manner as the claimed method and this feature does not differentiate the claimed invention from the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 10/14/2026
