FINAL ACTION
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 .
Status of the Claims
This action is in response to papers filed 07/02/2025 in which claims 2-3 and 5-44 were canceled; claim 45 was amended; and claims 47-51 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1, 4, and 45-51 are under examination.
Withdrawn Rejection
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained Objection
Claim Objections
Claims 45 and 46 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 1 and 4, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). It is noted that claims 45 and 1 are both drawn to compositions containing the same structures of D-PDMP encapsulated in a polyethylene-sebacic acid polymer in a dosage amount of 1 mg to 10 mg D-PDMP per kg of subject body weight. It is noted that claims 46 and 4 are both drawn to the same structures of the composition further comprising a therapeutic compound known to treat cardiac hypertrophy.
Response to Arguments
Applicant's arguments filed 07/02/2025 have been fully considered but they are not persuasive.
Applicant argues that claims 45 and 46 differ in that “claims 45 and 46 recite “oral” and “a unit dosage” amount of 1 mg to 10 mg of D-PDMP per keg of subject bodyweight.” (Remarks, middle of page 6).
In response, the Examiner disagrees. As discussed in the standing objection, to the extent claims 45 and 46 recite “oral” and “a unit dosage,” said recitations do not structurally differentiate from claims 1 and 4, respectively. This is because as discussed above in the standing objection, claims 45 and 1 are both drawn to compositions containing the same structures of D-PDMP encapsulated in a polyethylene-sebacic acid polymer in a dosage amount of 1 mg to 10 mg D-PDMP per kg of subject body weight; and claims 46 and 4 are both drawn to the same structures of the composition further comprising a therapeutic compound known to treat cardiac hypertrophy.
Accordingly the objections to claims 45 and 46 are maintained for the reason of record.
Claim Interpretation
Claim 51 contains the transitional phrase “consists essentially”. The phrase “consists essentially” is interpreted as defined by the instant specification. The specification defines “consists essentially” as “open-ended, allowing for the presence of more than that which is recited so long as basic or novel characteristics of that which is recited are not change by the presence of more than that which is recited …” (Specification, page 8, lines 19-22). Accordingly, if an applicant contends that additional materials in the prior art are excluded by the recitation of “consists essentially” applicant has the burden of showing that the introduction of additional components would materially change the characteristics of applicant's invention. PPG Industries Inc. V Guardian Industries Corp. 48 USPQ2d 1351 (Fed. Cir. 1998) and In re De Lajarte 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See MPEP §2111.03.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 4, and 45-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chatterjee (13 August 2009; US 2009/0202439 A1) in view of Hanes et al (8 May 2003; US 2003/0086895 A1).
Claim interpretation for claim 51 applies here.
Regarding claims 1, 45 and 47, Chatterjee teaches a composition for oral administration comprising (1R,2R)-1-phenyl-2-decanylamino-3-morpholino-1-propanol (D-PDMP) as a therapeutic agent, and biodegradable polymers encapsulating the therapeutic agent ([0009]-[0015], [0040], [0041], [0154], [0198]-[0207], [0222], [0223]; and claim 49), wherein the D-PDMP is present in a dose range from about 1 mg/kg to about 20 mg/kg of body weight, particularly, in a dose amount of 10 mg/kg of body weight ([0154]]). Chatterjee teaches the composition can further contain another therapeutic to be used in combination with D-PDMP such as probucol ([0056] and [0126]). Chatterjee teaches the composition is used for treating diabetes and vascular diseases ([0010] and [0012]). Chatterjee teaches that the suitable biodegradable polymer for use in the encapsulating the D-PDMP is one that can provide a slow or controlled release of the active ingredient (Chatterjee: [0207] and [0222]).
However, Chatterjee does not teach the polyethylene glycol – sebacic acid polymer of claims 1, 45, and 47.
Regarding the polyethylene glycol – sebacic acid polymer of claims 1, 45, and 47, Hanes teaches a composition for oral administration comprising a therapeutic agent encapsulated by a biodegradable polymer such as polyethylene glycol – sebacic acid polymer (poly(PEG:SA)) ([0012], [0013], [0016], [0018], [0021], [0025], [0028], [0034], [0035], [0047], [0150], [0152], [0199], [0200], [0202], [0205], [0247], [0260], [0261] and [0265]; Table 2).
It would have been obvious to one of ordinary skill in the art to incorporate polyethylene glycol – sebacic acid polymer (poly(PEG:SA) as the biodegradable polymer in the composition of Chatterjee and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Hanes teaches that the use of biodegradable polymer such as poly(PEG:SA) for encapsulation of a therapeutic agent provides a desired sustained release profile of the therapeutic agent (Hanes: [0016], [0034]-[0036], [0065] and [0066]), and Chatterjee teaches that the suitable biodegradable polymer for use in the encapsulating the D-PDMP is one that can provide a slow or controlled release of the active ingredient (Chatterjee: [0207] and [0222]). Thus, it would have been merely simple substitution of one known biodegradable polymer for another to obtained predictable results of a controlled/sustained release profile of the therapeutic agent from the composition, thereby achieving applicant's claimed invention with reasonable expectation of success.
It is noted that the limitations of "treating or reducing a symptom of atherosclerosis or cardiac hypertrophy” in claim 1, is a recitation of intended use. Thus, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the present case, the structures of the composition of claim 1 has been taught by Chatterjee in view of Hanes, and thus, the composition of Chatterjee in view of Hanes would be capable of performing the intended use of “treating or reducing a symptom of atherosclerosis or cardiac hypertrophy,” of the claimed invention.
Regarding claims 4, 46, and 48, Chatterjee teaches the composition can further contain another therapeutic to be used in combination with D-PDMP such as probucol ([0056] and [0126]).
Regarding claims 49-51, as discussed above, Chatterjee teaches the D-PDMP is present in a dose range from about 1 mg/kg to about 20 mg/kg of body weight ([0154]]). Thus, it would have been obvious for one of ordinary skill in the art to optimize the dosage amount of D-PDMP to 1 mg/kg, as recited in claim 49, based on the guidance from Chatterjee supra, teaching the minimum dosage amount of D-PDMP suitable for use is 1 mg/kg. Absent some demonstration of unexpected results from the claimed parameters, the optimization of the dosage amount of D-PDMP would have been obvious before the effective filing date of applicant's invention. “Where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 07/02/2025 have been fully considered but they are not persuasive.
Applicant argues by presenting the previously filed 132 Declaration of Dr. Subroto Chatterjee, therein providing evidence of unexpected enhanced results of the composition and polymer as recited in claim 3. Applicant alleges that the Declaration showed that polyethylene glycol-sebacic acid polymer provided enhanced results relative to polyactide-polyglycolide, and that polymer-encapsulated D-PDMP was more effective in reducing aortic intima media thickening as compared to treatments with D-PDMP without polymer. (Remarks, pages 4-5).
In response, the Examiner disagrees. The “Subroto Chatterjee” Declaration under 37 CFR 1.132 filed 02/20/2024 was previously considered, and remain insufficient to overcome the 103 rejection as set forth in the office action.
As previously discussed, it is reiterated that the Declaration of Dr. Subroto Chatterjee and evidence provided therein is insufficient to obviate the 103 rejection based on the combined teachings of Chatterjee and Hanes because the claims under examination are composition claims (product claims), and the structural components of the claimed composition comprising D-PDMP encapsulated in a polyethylene glycol-sebacic polymer has been taught and rendered obvious by Chatterjee and Hanes, in that Chatterjee teaches the encapsulated of D-PDMP using anhydride biodegradable polymers and Hanes provided the guidance and motivation for using particularly polyethylene glycol-sebacic polymer as the suitable anhydride polymer over other biodegradable polymers including PLGA for encapsulating therapeutic agent such as D-PDMP so as to achieve the desired controlled/sustained release profile of the therapeutic agent. Furthermore, the problem with PLGA as not suitable polymer for sustained release due their faster release of drugs was already recognized in the prior art in view of Hanes. Hanes recognized PLGA has many limitations including delivering drugs for a shorter period of time and thus, Hanes resolved the this problem by using polyethylene glycol-sebacic polymer as the biodegradable polymers for encapsulating drugs including basic drugs so as to provide the desired sustained release profiles of the drug (Hanes: [0010] and [0034]).
It is further reiterated that Applicant’s evidence of unpredictability of the art showing PLGA as not suitable or inefficient biopolymer to deliver D-PDMP, was rendered insufficient evidence of nonobviousness because Applicant has failed to show a species of anhydride polymer that did not work to the same extent as the claimed polyethylene glycol-sebacic polymer when used as the polymer for encapsulation of D-PDMP. There was no persuasive evidence in the Declaration showing unpredictability of the art with respect to the genus of polyanhydride biodegradable polymer, showing that not all species encompassed by the genus of polyanhydride biodegradable polymer would be expected to behave in the same manner as the claimed polyethylene glycol-sebacic acid polymer to achieve X results. It is noted that Chatterjee indicated that poly(anhydrides) are suitable biodegradable polymers for use as the encapsulating polymer (Chatterjee: [0222]). Thus, it is reiterated that absence such evidence of unpredictability of the art with respect to anhydride biodegradable polymers, independent claims 1 and 45 remain obvious for the reasons of record because the benefit that Applicant has found and described in the Declaration with respect to using polyethylene glycol-sebacic polymer (a polyanhydride polymer) over other biodegradable polymers such as PLGA has been recognized and expected in the prior art. As such, it is noted that "[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
As a result, for at least the reasons discussed above, claims 1, 4, and 45-51 remain obvious and unpatentable over the combined teachings Chatterjee and Hanes in the standing 103 rejection as set forth in this office action.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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, 4, and 45-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18, 26 and 44-52 of copending Application No. 16972575 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘575 significantly overlap with subject matter of instant claims, i.e., claims in copending application ‘575 being method of using claims, but uses the same composition comprising an effective amount of a biopolymer-encapsulated glycosphingolipid synthesis inhibitor, wherein the glycosphingolipid synthesis inhibitor is D-threo-1-phenyl-2-decanyolamino-3-morpholino-1-propanol (D-PDMP), wherein the D-PDMP is encapsulated in a polyethylene glycol – sebacic acid polymer, and wherein the D-PDMP is present in a dose amount of 1 mg to 10 mg per kg of subject bodyweight.
Furthermore, it is noted that the "[n]onstatutory Double Patenting Rejection Based on Equitable Principles" discussed in paragraph II.B.3 below should be considered. Cf. Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003) (rejecting claims to methods of use over claims to compound based on unjustified timewise extension rationale).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 16972575 in view of Chatterjee.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 07/02/2025 have been fully considered but they are not persuasive.
Applicant argues “[t]he present claims differ from the cited claims. The present claims recite dosage amounts not recited in the cited claims. The present claims 45-51 also recite "oral"” (Remarks, bottom of page 6).
In response, the Examiner disagrees. As discussed above, the claims in the instant application and the claims in copending application ‘575 use the same composition, in which independent claims 18 and 26 in the methods of copending application ‘575 to uses the same composition comprising an effective amount of a biopolymer-encapsulated glycosphingolipid synthesis inhibitor, wherein the glycosphingolipid synthesis inhibitor is D-threo-1-phenyl-2-decanyolamino-3-morpholino-1-propanol (D-PDMP), wherein the D-PDMP is encapsulated in a polyethylene glycol – sebacic acid polymer, and wherein the D-PDMP is present in a dose amount of 1 mg to 10 mg per kg of subject bodyweight, as the instant claims. Contrary to Applicant’s allegation the claimed dosage amounts as recited in the instant claims (“amount of 1 mg to 10 mg per kg of subject bodyweight”) is also recited in independent claims 18 and 26 of the copending application ‘575.
Furthermore, as discussed in the double patenting rejection, for also the reason of unjustified timewise extension rationale, the provisional double patent rejection over copending Application No. 16972575 is maintained.
As a result, for at least the reasons discussed above, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 16972575.
New Rejection
Necessitated by Applicant Claim Amendments
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 45-46 and 48-51 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 45 and 46, the recitation of “An oral A pharmaceutical composition” in claim 45 and “The pharmaceutical composition of claim 45” in claim 46 render said claims 45 and 46 indefinite because it is unclear if claim 45 is claiming “an oral composition ” or “a pharmaceutical composition,” as claim 46 recites “The pharmaceutical composition of claim 45” but claim 45 also recited “An oral”. Thus, there is lack of antecedent basis in both claims 45 and 46. Clarification in said claims are required.
Regarding claims 48-51, the recitations of “the oral pharmaceutical composition” render said claims 48-51 indefinite because claim 47 to which claims 48-51 depend from is drawn to “An oral single dosage pharmaceutical composition” and not “an oral pharmaceutical composition.” Thus, there is lack of antecedent basis for “the oral pharmaceutical composition” in claim 47. Clarification in claims 48-51 are required.
As a result, claims 45-46 and 48-51 do not clearly set forth the metes and bounds of patent protection desired.
Conclusion
No claim is allowed.
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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613