DETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 10/24/25 has been entered.
Election/Restrictions and Claim Status
The Patent Trial and Appeal Board Oral Hearing Transcript was entered into the case file on 10/31/25.
Applicants’ arguments and amendments filed 10/24/25 are acknowledged. Further, an affidavit was filed on 12/1/25.
Previously the peptidomimetic as set forth in the reply of 12/23/23 and the disease of age-related macular degeneration were elected. Although applicants refer to salts (page 23 of reply of 4/12/24) the original species election (12/23/23) recited a specific structure and referred to section 0085 which recites a specific structure. No particular salt was identified.
Since applicant elected age-related macular degeneration, claims 20-21 and 121 are drawn to non-elected species. Since applicant elected the peptidomimetic as set forth in the reply of 12/23/23 (and not a specific salt), claims 17, 95, 100, 109, 113, 114 (which depends on claim 113) and 117 are drawn to a non-elected species.
Although the elected peptidomimetic is not a salt, claim 16 is included in the instant examination. Although claims 19, 99 and 120 do not necessarily read on the elected species, they are included in the instant examination.
Claims 17, 20-21, 95, 100, 109, 113-114, 117 and 121 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/23.
Claims 2-7, 14-15, 22-54, 56-60, 64-70, 72-76 and 78-89 have been canceled.
Newly submitted claims 122-133 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Invention 1 (new submitted claims 122-133) and Invention 2 (claims 1, 8-13, 16-21, 55, 61-63, 71, 77, 90-121) are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the peptidomimetic can be used in a different process where is it administered for a disease other than an ophthalmic disease.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 122-133 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1, 8-13, 16, 18-19, 55, 61-63, 71, 77, 90-94, 96-99, 101-108, 110-112, 115-116 and 118-120 are being examined.
Priority
The priority information is found in the filing receipt of 12/13/23.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/2/26 and 10/24/25 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The 112 rejections are new rejections necessitated by amendment.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 104 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 104 depends on claim 102. Claim 102 requires not merely any therapeutic agent but an agent that is selected from “an antioxidant, a metal complexer, an anti-inflammatory drug, an antibiotic, and an antihistamine”. The instant specification (page 51 section 0122) recites “In one embodiment, the formulation further comprises an active agent selected from the group consisting of:” and then recites agents as in claim 104. The language used in the specification for that statement is “active agent”. Not all active agents are “an antioxidant, a metal complexer, an anti-inflammatory drug, an antibiotic, and an antihistamine”. For example, instant claim 104 recites ganciclovir, trifluridine and vidarbine. AU 2015264908 (Gallem et al.) teach that ganciclovir, trifluridine and vidarbine are anti-viral agents (page 26, the 6th grouping). An anti-viral agent is not necessarily an antioxidant, a metal complexer, an anti-inflammatory drug, an antibiotic, or an antihistamine.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 103 is 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.
Claim 103 recites ‘wherein ophthalmic disease’. Claim 103 depends on claim 18 which depends on claim 1. Claim 18 recites ‘wherein the ophthalmic disease’. Since claim 103 generically refers to ‘ophthalmic disease’ (not to ‘the ophthalmic disease’) it is unclear if claim 103 is requiring the subject of claim 1 to have multiple diseases or if claim 103 is further describing the ophthalmic disease.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended and new claims added, the rejection is updated to correspond to the instant claims.
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.
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.
Claim(s) 1, 8-13, 16, 18-19, 55, 61-63, 71, 77, 90-94, 96-99, 101-108, 110-112, 115-116 and 118-120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (WO 2019/118878 as cited with IDS 12/23/23; ‘Zheng’) in view of Wilson et al. (US 2015/0018288; ‘Wilson’; previously cited).
Zheng teach mitochondrial targeting peptides compounds have shown therapeutic potential for treating diseases associated with mitochondrial dysfunction (page 1 ‘Background of Invention’). Zheng teach specific compounds including compound 7a and synthesis thereof (example 31 beginning on page 87). Zheng also shows a compound corresponding to compound 7a as the first compound in figure 1. Zheng teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 was displaced (page 187 for example). Zheng teach compound binding affinity results in table 1 (page 189 results) and specifically shows that the first compound had level ‘A’ binding (figure 1). Zheng refers to high affinity values (page 188 last paragraph). Zheng teach that the subject is human (page 24 3rd complete paragraph). Zheng teach subcutaneous, topical and intravenous administration (page 24 4th complete paragraph). Zheng specifically recognizes administration to the eye (page 27 2nd paragraph). Zheng teach daily doses (page 26 2nd complete paragraph). Zheng teach that the administration is for 12 weeks or more (page 43 lines 6-7). Zheng teach a trifluoroacetate salt of the peptidomimetic (page 23 6th complete paragraph, page 39 2nd paragraph).
Zheng does not specifically teach a subject with age-related macular degeneration.
Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 (abstract) which is also called SS-31 (section 0063) for treating ophthalmic conditions (abstract). Wilson teach administration of a peptide to treat age-related macular degeneration including dry macular degeneration (section 0178). Wilson teach a subject with drusen (section 0209). Wilson teach administration of an effective amount (abstract and section 0001). Wilson teach that the subject is human (section 0008). Wilson teach subcutaneous, intraocular and oral administration (section 0059). Wilson teach administration directly to the eye via eye drops (section 0194). Wilson teach daily dosages (section 0277). Wilson teach an additional therapeutic agent that can be administered simultaneously (section 0009). Wilson specifically recites an antioxidant or anti-inflammatory as a further component (section 0062). Wilson teach that the use of antioxidants have been shown to benefit patients with macular degenerations (section 0285). Wilson teach that macular degeneration is characterized by inflammation (section 0003). Wilson teach that suitable anti-inflammatories include cromolyn (section 0292). Wilson recognizes diseases where there are problems with the retina and refers to oxidative damage (sections 0003-0004). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 as an antioxidant to reduce photoreceptor cell death (example 8 pages 32-33). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351). Wilson teach that there is mounting evidence that dysfunctional mitochondria are the primary source of reactive oxygen species and the eye is at considerable risk from oxidative stress (section 0155). Wilson recognizes the use of amino acid mimetics (section 0110). Wilson teach ophthalmic delivery (sections 0252-0260). Wilson teach examples with 1% peptide (sections 0302-0303). Wilson teach the inclusion of a buffer (sections 0239-0240 and 0245). Wilson teach the inclusion of water (sections 0239-0241). Wilson teach eye drops (section 0244). Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 and applications for any cell, tissue or organ of the central and peripheral nervous system (section 0230).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Zheng because Zheng teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 (page 187 for example) was displaced with compound 7a (the first compound in figure 1). Thus one would have been motivated to use compound 7a in the known ways that D-Arg-Dmt-Lys-Phe-NH2 was used. Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 (abstract) which is also called SS-31 (section 0063) for treating ophthalmic conditions (abstract). Wilson teach administration of a peptide to treat age-related macular degeneration including dry age-related macular degeneration (section 0178). Additionally, Zheng teach mitochondrial targeting peptides compounds have shown therapeutic potential for treating diseases associated with mitochondrial dysfunction (page 1 ‘Background of Invention’).
Wilson teach that the use of antioxidants have been shown to benefit patients with macular degenerations (section 0285). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 as an antioxidant to reduce photoreceptor cell death (example 8 pages 32-33). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351).
Since Wilson teach that there is mounting evidence that dysfunctional mitochondria are the primary source of reactive oxygen species and the eye is at considerable risk from oxidative stress (section 0155) one would have been motivated to administer to the subjects taught by Wilson using formulations taught by Wilson. Further, Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson recognizes the use of amino acid mimetics (section 0110) and compound 7a of Zheng comprises D-Arg-Dmt-Lys (the same first residues of the peptide of Wilson) and a mimetic residue.
Since Wilson specifically recites an anti-inflammatory as a further component (section 0062) and teach that macular degeneration is characterized by inflammation (section 0003) one would have been motivated to include the anti-inflammatory cromolyn (section 0292 of Wilson).
One would have had a reasonable expectation of success because Zheng specifically recognizes administration to the eye (page 27 2nd paragraph). Zheng teach specific compounds including compound 7a and synthesis thereof (example 31 beginning on page 87). Zheng teach compound binding affinity results in table 1 (page 189 results) and specifically shows that the first compound had level ‘A’ binding (figure 1). Further, Wilson teach that the use of antioxidants have been shown to benefit patients with macular degenerations (section 0285). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 as an antioxidant to reduce photoreceptor cell death (example 8 pages 32-33). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351). In addition, Wilson teach that macular degeneration is characterized by inflammation (section 0003). Wilson teach the known anti-inflammatory cromolyn (section 0292 of Wilson).
In relation to the peptidomimetic of claims 1, 55, 71 and 90, Zheng teach specific compounds including compound 7a and synthesis thereof (example 31 beginning on page 87). Compound 7a is the elected species and corresponds to formula II of the instant claims.
In relation to claim 16, Zheng teach a trifluoroacetate salt of the peptidomimetic (page 23 6th complete paragraph, page 39 2nd paragraph).
In relation to the subject of claims 1, 18, 55, 61, 71, 77, 90, 93, 98, 103, 107, 112 and 119, Wilson teach administration of a peptide to treat age-related macular degeneration including dry age related macular degeneration (section 0178). Wilson teach administration of an effective amount (abstract and section 0001). Since Zheng teach the elected peptidomimetic it would function as claimed (for example delaying the onset of ellipsoid zone integrity of claims 55 and 77 and 119 and delaying the onset of geographic atrophy of claim 71).
In relation to claims 8, 62, 108 and 118, Wilson teach that the subject is human (section 0008).
In relation to claims 9-11, 63, 91-92, 94 and 96, Zheng teach subcutaneous, topical and intravenous administration (page 24 4th complete paragraph). Wilson teach administration directly to the eye via eye drops (section 0194).
In relation to claim 12, Zheng teach daily doses (page 26 2nd complete paragraph). Zheng teach that the administration is for 12 weeks or more (page 43 lines 6-7). Wilson recognizes that the schedule of doses can be optimized (section 0237).
In relation to claim 13, Wilson teach an additional therapeutic agent than can be administered simultaneously (section 0009).
In relation to claims 19, 99 and 120, Wilson teach a subject with drusen (section 0209).
In relation to claims 97, 101, 105-106, 110-111 and 115-116, Wilson teach examples with 1% peptide (sections 0302-0303). Wilson teach the inclusion of a buffer (sections 0239-0240 and 0245). Wilson teach the inclusion of water (sections 0239-0241).
In relation to claim 102, Wilson specifically recites an antioxidant or anti-inflammatory as a further component (section 0062).
In relation to claim 104, Wilson teach that suitable anti-inflammatories include cromolyn (section 0292).
Response to Arguments - 103
Applicant's arguments filed 10/24/25 have been fully considered but they are not persuasive. Although no specific argument was provided, an affidavit was submitted 12/1/25 but it is not found persuasive as discussed below.
Although applicants argue that they traverse for the reasons set forth in the Brief filed September 30, 2024, such arguments were addressed in the Examiner’s Answer dated 1/15/25 and that reply remains of record. More details are provided below.
Although applicants argue that they traverse for the reasons provided in the Reply Brief filed March 14, 2024, it is noted that the Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25. There is nothing in the record indicating that any of the arguments were found persuasive. More details are provided below.
Although applicants submit an affidavit on 12/1/25, the affidavit refers to exhibits A-F. None of exhibits A-F have been provided. More details are provided below.
Although applicants argue about deterioration of claim 55 or onset of claim 71, both claims refer to ‘preventing’ and thus do not require a subject with a certain degree of deterioration or with geographic atrophy. The active step of the claims is administration which is suggested by the prior art as discussed in the rejection above.
With respect to arguments in the appeal brief:
Applicants recite case law and argue that there is no evidence that Zheng’s well plate based radioligand displacement studies and affinity binding results in rat heart homogenate provide any indication of treating an ophthalmic condition (pages 8-12 of the appeal brief).
In response to Applicants’ arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, Zheng not only teach a peptidomimetic (compound 7a example 31 beginning on page 87) as in the instant claims but also teach the peptides of the invention as mitochondria-targeting (title and page 1 section ‘Background of the Invention’). Further, Zheng teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 (page 187 for example) was displaced with compound 7a (the first compound in figure 1). The radioligand displacement binding ties in the functional properties of the compound of Zheng.
With respect to applicability to ophthalmic disorders, Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 (abstract) which is also called SS-31 (section 0063) for treating ophthalmic conditions (abstract) including preventing oxidative stress in retinal cells (example 5 beginning on page 31) and as an antioxidant to reduce photoreceptor cell death (example 8 beginning at section 0351 on page 32). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351). Wilson teach that there is mounting evidence that dysfunctional mitochondria are the primary source of reactive oxygen species and the eye is at considerable risk from oxidative stress (section 0155). Wilson specifically teach the peptide D-Arg-Dmt-Lys-Phe-NH2 and applications for ‘any cell, tissue or organ of the central and peripheral nervous system’ (section 0230) and specifically recites ‘contacting a cell, organ or tissue with a peptide’ (section 0235). Thus, Wilson does not limit to any specific cell or organ or tissue. Since Zheng teach that compound 7a displaces D-Arg-Dmt-Lys-Phe-NH2 in a binding assay one would have been motivated to use compound 7a in the known ways that D-Arg-Dmt-Lys-Phe-NH2 was used.
In summary, the rat heart homogenate data of Zheng is relevant because is establishes binding of compound 7a, specifically as displacing D-Arg-Dmt-Lys-Phe-NH2. Thus, one would recognize both peptides as having a common target (mitochondria) and function (antioxidant). Zheng expressly teach the peptides as mitochondria-targeting (title and page 1 section ‘Background of the Invention’). Further, Wilson specifically teach the peptide D-Arg-Dmt-Lys-Phe-NH2 and applications for ‘any cell, tissue or organ of the central and peripheral nervous system’ (section 0230) and specifically recites ‘contacting a cell, organ or tissue with a peptide’ (section 0235). There is no evidence of record that the mitochondria present in rat heart is an inadequate model of mitochondria present in the eye. The facts show that Zheng teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 (page 187 for example) was displaced with compound 7a (the first compound in figure 1). This clearly shows that both compound 7a and D-Arg-Dmt-Lys-Phe-NH2 are able to bind the rat heart homogenate. It appears that Applicants are improperly suggesting the need for conclusive proof in a 103 rejection. MPEP 2143.02 I states: “Conclusive proof of efficacy is not required to show a reasonable expectation of success”.
The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25 and it is noted that page 8 lines 2-8 and lines 17-18 are relevant and appear to be consistent with the examiner’s position. In fact, lines 17-18 of page 8 recite “the Examiner has given us evidence of a reasonable expectation of success”. Page 10 lines 10-11 of the Patent Trial and Appeal Board Hearing Transcript also refers to providing a reasonable expectation. Page 11 lines 1-3 of the Patent Trial and Appeal Board Hearing Transcript refers to a prima facia case explained by the Examiner. Page 12 line 1 of the Patent Trial and Appeal Board Hearing Transcript refers to a reasonable expectation.
Applicants argue that Wilson does not teach the elected species (pages 11 and 19 of the appeal brief).
The instant rejection is a multiple reference 103 rejection. With respect to the claim limitation of the peptidomimetic, as stated on page 7 of the 4/25/24 office action:
“In relation to the peptidomimetic of claims 1, 55, 71 and 90, Zheng teach specific compounds including compound 7a and synthesis thereof (example 31 beginning on page 87). Compound 7a is the elected species and corresponds to formula II of the instant claims.” Thus, the elected species is clearly taught by the prior art.
Applicants recite case law and argue that there is not a reasonable expectation that compound 7a would penetrate eye tissue and refer to OSI Pharm., LLC v. Apotex Inc (pages 12-14 of the appeal brief).
First, it is noted that the active step of the instant claims is ‘administering’. None of the claims specifically refer to any particular degree of eye penetration.
Further, Wilson expressly teach administration intraocularly (sections 0059-0060). Wilson teach topical installation of labeled D-Arg-Dmt-Lys-Phe-NH2 (section 0306 page 27) and shows in Table 8 the distribution within various areas of the eye (page 27). D-Arg-Dmt-Lys-Phe-NH2 of Wilson (on the left below) and compound 7a of Zheng (on the right below) are as follows:
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The molecules include the same first 3 side chain residues corresponding to D-Arg-DMT-Lys. Due to the structural similarity, it is unclear why Applicants are of the apparent position that compound 7a of Zheng could not be administered intraocularly.
With respect to the facts of the OSI Pharm., LLC v. Apotex Inc., MPEP 2143.02 II recites:
“See also OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("These references provide no more than hope—and hope that a potentially promising drug will treat a particular cancer is not enough to create a reasonable expectation of success in a highly unpredictable art such as this. Indeed, given a 99.5% failure rate and no efficacy data or any other reliable indicator of success, the only reasonable expectation at the time of the invention was failure, not success."
In the instant case, Applicants have not pointed to a failure rate (for example a 99.5% failure rate) related to the instant facts. The facts of this case reveal that Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 (abstract) which is also called SS-31 (section 0063) for treating ophthalmic conditions (abstract) including preventing oxidative stress in retinal cells (example 5 beginning on page 31). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155 and 0228). More specifically, as set forth in the question and answer on pages 6-7 of the decision as provided in the appeal brief appendix (pages 453-454), it was recognized that the treatment of one cancer does not mean that it would succeed in treating another type of cancer (last 5 lines of page 453 and first line of page 454). In contrast, Zheng generically refers to mitochondria-targeting peptides (title). Zheng teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 (page 187 for example) was displaced with compound 7a in rat heart (the first compound in figure 1). Further, Wilson specifically teach the peptide D-Arg-Dmt-Lys-Phe-NH2 and applications for ‘any cell, tissue or organ of the central and peripheral nervous system’ (section 0230) and specifically recites ‘contacting a cell, organ or tissue with a peptide’ (section 0235). Thus, the predictability and evidence related to a mitochondria targeting peptide that is known to act as an antioxidant is quite different from that related to cancer treatments with certain compounds. As set forth in MPEP 2143.02 I: “Conclusive proof of efficacy is not required to show a reasonable expectation of success”.
The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25 and it is noted that page 8 lines 2-8 and lines 17-18 are relevant and appear to be consistent with the examiner’s position. In fact, lines 17-18 of page 8 recite “the Examiner has given us evidence of a reasonable expectation of success”. Page 10 lines 10-11 of the Patent Trial and Appeal Board Hearing Transcript also refers to providing a reasonable expectation. Page 11 lines 1-3 of the Patent Trial and Appeal Board Hearing Transcript refers to a prima facia case explained by the Examiner. Page 12 line 1 of the Patent Trial and Appeal Board Hearing Transcript refers to a reasonable expectation.
Applicants argue that the art recognizes that amino acid mimetics of Wilson would not be expected to be useful (pages 14-20). Applicants specifically argue about the Patani reference (pages 15-16).
The instant rejection is a multiple reference 103 rejection. The rejection is based on using the peptide as taught by Zheng (no modification of the peptide is required). With respect to the claim limitation of the peptidomimetic, as stated on page 7 of the 4/25/24 office action:
“In relation to the peptidomimetic of claims 1, 55, 71 and 90, Zheng teach specific compounds including compound 7a and synthesis thereof (example 31 beginning on page 87). Compound 7a is the elected species and corresponds to formula II of the instant claims.” Thus, the elected species is clearly taught by the prior art. No modification of compounds is required. The rejection is not based on modifying specific residues of a peptide. The rejection is based on using the peptide as taught by Zheng. The final rejection (4/25/24 page 6) expressly states: “one would have been motivated to use compound 7a in the known ways that D-Arg-Dmt-Lys-Phe-NH2 was used”.
Importantly, Zheng not only teach a peptidomimetic (compound 7a example 31 beginning on page 87) as in the instant claims but also teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 (page 187 for example) was displaced with compound 7a (the first compound in figure 1). The Wilson reference does recite that functional analogs include those with one or more amino acid substitution (section 0143). Whether or not additional modified compounds may function as claimed is not particularly relevant to the instant rejection.
With respect to the arguments about Patani, the instant 103 rejection is not based on Patani. The final rejection (4/25/24 page 6) expressly states: “one would have been motivated to use compound 7a in the known ways that D-Arg-Dmt-Lys-Phe-NH2 was used”. The Patani reference was cited in response to arguments about unexpected results. MPEP 716.02 expressly states: “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected”. The Patani reference was cited to establish what was known about certain types of substitutions (the response to arguments about unexpected results it set forth below).
Applicants argue that the claims are non-obvious in view of surprising and unexpected benefits arising therefrom (pages 21-28 of the appeal brief). Applicants point to the results in figures 2-7 (page 21 of the appeal brief).
MPEP 716.02(b) I states: “The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance”.”
MPEP 716.02(b) II states: “[A]ppellants have the burden of explaining the data”.
Figure 4 is as follows:
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From the data as provided in figure 4, it is unclear if there are any actual statistical differences in the data. In similar fashion, it is unclear if figures 1 and 6 show any statistical difference in the data. The specification merely states that statistical analysis was as described in Gong et al. (section 0279). Although Gong et al. (cited with IDS 12/23/23) reports P values (for example in figure 2) no P values or evidence of statistical significance are provided in the instant specification (for figure 4 or for any figure). Applicants state: “the data speaks for itself” (page 26 2nd to last paragraph of page 26 of the appeal brief). In the instant case, it has not been established that results are of statistical significance.
Section 0263 of the specification recites that concentrations were ‘determined utilizing a method previously developed by the CRO’. It is unclear how the concentrations were determined. It is unclear what specific agent or agent concentrations were determined. It is unclear if only salt forms or if any metabolite forms were determined. As such, the meaning of the error bars in the figures is unclear. Absent any type of statistical analysis it is unclear if any results are statistically significant.
MPEP 716.02 expressly states: “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected”.
D-Arg-Dmt-Lys-Phe-NH2 of Wilson (on the left below) and compound 7a of Zheng (on the right below) are as follows:
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Zheng teach a need for novel compounds with improved efficacy and therapeutic profiles (page 1 ‘Background of the Invention).
Wilson et al. (US 2015/0018288; ‘Wilson’; previously cited) reports an apparent terminal half life on the order of hours for D-Arg-Dmt-Lys-Phe-NH2 and variability in the location within the eye after topical installation (Table 8 page 27).
One of the differences between the compound of Wilson and the compound of Zheng is that the compound of Zheng includes a 5 membered heterocyclic ring. Patani et al. (‘Bioisosterism: a rational approach in drug design’ Chem Rev v96 1996 pages 3147-3176; previously cited) recognizes the use of oxadiazoles for replacement of amide bonds to convert peptides into chemically stable molecules (page 3170 section 4 and figure 76, specifically first paragraph of section 4). Table 44 (page 3169) of Patani shows marked improvements in compounds that contain an oxadiazole replacement. Patani expressly refers to heterocyclic rings such as 1,2,4-oxadiazoles (92) (page 3170 2nd paragraph of section 4).
Parsons et al. (cite A70 of IDS 12/23/23) teach that the vitreous contains a high level of proteolytic enzymes (section 3.3.8 page 17).
In the instant case, it appears that the testing conditions were conducted in a location with a high level of proteases and compared to a compound that included a chemically stabilizing group/modification. Zheng expressly refers to compounds with improved efficacy and therapeutic profiles (page 1 ‘Background of the Invention of Zheng). Thus, the mere fact that compounds of Zheng might have beneficial properties is not necessarily unexpected. Further, it appears that the test conditions compared a salt form (page 23 of the appeal brief) to a compound that does not appear to be in salt form (elamipretide).
MPEP 716.02(d) recognizes that objective evidence of nonobviousness must be commensurate in scope with the claims. The instant claims encompass ‘salt, stereoisomer, tautomer, hydrate and/or solvate’ as well as optionally substituted deuterium and fluorine. Such possibilities can range in molecular weight and properties including the charge. Applicants show a structure that includes charged components (page 23 of the appeal brief). It does not appear that the comparative compound (elamipretide) is a salt. With respect to the data of the examples in the specification, the specification (section 0250) refers to compound of formula IIa which is described as a salt (section 0249). The independent claims generically recite administering. Figure 1A (to the extent that is can be interpreted) appears to show similar results for SC administration. Applicants own statement in comparing the results is ‘roughly equivalent’ in section 0264 of the specification. The instant claims broadly recite ‘mammalian subject’. There are inadequate facts to conclude any unexpected results commensurate in scope with the claims.
In addition, the most recent amendments greatly broaden the scope of the claims. In addition to salts, stereoisomers, tautomer, hydrates and solvates the instant claims also refer to one or more of the hydrogen atoms can be optionally substituted with a deuterium or fluorine atom. Formula II includes 45 hydrogen residues. There are many possible combinations and permutations of hydrogen and deuterium and salts, etc.
The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25 and page 17 line 23 - page 18 line 1 and page 18 lines 7-8, 10-13 provide additional discussion about the data. Page 17 lines 23-24 recite ‘It doesn’t really say that they’re surprising or unexpected results” . Page 13 lines 6-9 recognizes that merely pointing out differences is not necessarily enough.
Applicants argue that with respect to “corrected for potency” that “The elamipretide solution for dosing contained 3 mg/mL elamipretide and the solution of compound of Formula IIa was also prepared at 3 mg/kg” (page 23 of the appeal brief first bullet point).
The information provided by the Applicant is confusing because 3 mg/ml is not necessarily the same as 3 mg/kg. MPEP 716.02(b) II states: “[A]ppellants have the burden of explaining the data”.
Section 0260 of the specification refers to administration twice daily and every 8 to 12 hours for 11 total doses. The length of time from the final administration to the measurement of concentration (compare y-axis in figure 2 for example) is important because Wilson et al. (US 2015/0018288; ‘Wilson’; previously cited) expressly recognizes that D-Arg-Dmt-Lys-Phe-NH2 is susceptible to oxidation (section 0362) and Wilson shows an apparent terminal half life on the order of hours (Table 8 page 27). The time frame of ‘8 to 12 hours’ allows for a difference of approximately 4 hours. When the apparent terminal half life of a peptide is on the order of hours, a 4 hour difference is significant.
Applicants argue that comparison to Wilsons’s elamipretide only experiment is “inappropriate and irrelevant” (page 24 of the appeal brief).
MPEP 716.02 expressly states: “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected”. Thus, a comparison to what was known in the art is not irrelevant.
Applicants argue that head to head comparisons were made and there is no requirement for disclosing the methodology used to analyze statistical significance and that “the data speaks for itself” (pages 25-28 specifically the 2nd to last paragraph of page 26).
MPEP 716.02(b) I states: ‘The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance’. In the instant case (as discussed above) it is unclear whether or not the data as provided is of statistical significance. It is unclear what feature or what specific data is ‘surprising’. Further, the practical significance of the data has not been clearly set forth. There are inadequate facts to conclude any unexpected results commensurate in scope with the claims.
With respect to the reply brief (in addition to above and in addition to the Examiner’s Answer and in addition to the Oral Hearing Transcript):
Although applicants argue about the references individually, the instant rejection is a multiple reference 103 rejection and as such any single reference does not necessarily anticipate the claims. There is no statement in the instant rejection related to Wilson teaching the elected peptidomimetic.
Although applicants argue about a motivation to combine, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Zheng because Zheng teach radioligand displacement methods (example 88 beginning on page 186) in which the labeled peptide D-Arg-Dmt-Lys-Phe-NH2 (page 187 for example) was displaced with compound 7a (the first compound in figure 1). Thus one would have been motivated to use compound 7a in the known ways that D-Arg-Dmt-Lys-Phe-NH2 was used. Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 (abstract) which is also called SS-31 (section 0063) for treating ophthalmic conditions (abstract). Wilson teach administration of a peptide to treat age-related macular degeneration including dry age-related macular degeneration (section 0178). Additionally, Zheng teach mitochondrial targeting peptides compounds have shown therapeutic potential for treating diseases associated with mitochondrial dysfunction (page 1 ‘Background of Invention’).
Wilson teach that the use of antioxidants have been shown to benefit patients with macular degenerations (section 0285). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 as an antioxidant to reduce photoreceptor cell death (example 8 pages 32-33). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351).
Since Wilson teach that there is mounting evidence that dysfunctional mitochondria are the primary source of reactive oxygen species and the eye is at considerable risk from oxidative stress (section 0155) one would have been motivated to administer to the subjects taught by Wilson using formulations taught by Wilson. Further, Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson recognizes the use of amino acid mimetics (section 0110) and compound 7a of Zheng comprises D-Arg-Dmt-Lys (the same first residues of the peptide of Wilson) and a mimetic residue.
Since Wilson specifically recites an anti-inflammatory as a further component (section 0062) and teach that macular degeneration is characterized by inflammation (section 0003) one would have been motivated to include the anti-inflammatory cromolyn (section 0292 of Wilson).
Although applicants argue about a reasonable expectation of success, one would have had a reasonable expectation of success because Zheng teach specific compounds including compound 7a and synthesis thereof (example 31 beginning on page 87). Zheng teach compound binding affinity results in table 1 (page 189 results) and specifically shows that the first compound had level ‘A’ binding (figure 1). Further, Wilson teach that the use of antioxidants have been shown to benefit patients with macular degenerations (section 0285). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 as an antioxidant to reduce photoreceptor cell death (example 8 pages 32-33). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351). In addition, Wilson teach that macular degeneration is characterized by inflammation (section 0003). Wilson teach the known anti-inflammatory cromolyn (section 0292 of Wilson).
The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25 and it is noted that page 8 lines 2-8 and lines 17-18 are relevant and appear to be consistent with the examiner’s position. In fact, lines 17-18 of page 8 recite “the Examiner has given us evidence of a reasonable expectation of success”. Page 10 lines 10-11 of the Patent Trial and Appeal Board Hearing Transcript also refers to providing a reasonable expectation. Page 11 lines 1-3 of the Patent Trial and Appeal Board Hearing Transcript refers to a prima facia case explained by the Examiner. Page 12 line 1 of the Patent Trial and Appeal Board Hearing Transcript refers to a reasonable expectation.
Although applicants argue about the relevance of Patani, MPEP 716.02 expressly states: “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected”. Thus, a comparison to what was known in the art is relevant. A comparison does not need to be an anticipatory reference and teach the same exact compound to provide a basis of what was known in the art.
D-Arg-Dmt-Lys-Phe-NH2 of Wilson (on the left below) and compound 7a of Zheng (on the right below) are as follows:
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.
The molecules include the same first 3 side chain residues corresponding to D-Arg-DMT-Lys. The next part of the molecule is either an amide bond (compound of Wilson) or an oxadiazole (compound of Zheng).
Patani et al. (‘Bioisosterism: a rational approach in drug design’ Chem Rev v96 1996 pages 3147-3176; previously cited) recognizes the use of oxadiazoles for replacement of amide bonds to convert peptides into chemically stable molecules (page 3170 section 4 and figure 76, specifically first paragraph of section 4). Table 44 (page 3169) of Patani shows marked improvements in compounds that contain an oxadiazole based replacement. Patani expressly refers to heterocyclic rings such as 1,2,4-oxadiazoles (92) (page 3170 2nd paragraph of section 4).
The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25. Page 13 lines 6-9 recognizes that “just pointing out differences and that it’s a change in a stereocenter doesn’t provide any scientific discussion or support for why one of ordinary skill would say, oh, that’s a big deal in this kind of molecule”.
Although applicants argue about unexpected results, such arguments are addressed above. In addition, the most recent amendments greatly broaden the scope of the claims. In addition to salts, stereoisomers, tautomer, hydrates and solvates the instant claims also refer to one or more of the hydrogen atoms can be optionally substituted with a deuterium or fluorine atom. Formula II includes 45 hydrogen residues. There are many possible combinations and permutations of hydrogen and deuterium and salts, etc.
The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25 and page 17 line 23- page 18 line 1 and page 18 lines 7-8, 10-13 provide additional discussion about the data. Page 17 lines 23-24 recite ‘It doesn’t really say that they’re surprising or unexpected results” . Page 15 lines 13-19 recognizes Patani refers to peptide bonds and peptide fragments and it no necessarily limited to a particular location.
Although applicants argue about deterioration of claim 55 or onset of claim 71, both claims refer to ‘preventing’ and thus do not require a subject with a certain degree of deterioration or with geographic atrophy. The active step of the claims is administration.
With respect to the affidavit submitted 12/1/25:
MPEP 2145 I recognizes that arguments presented by the applicant cannot take the place of evidence in the record. The affidavit refers to exhibits A-F. None of exhibits A-F have been provided. Although some of the exhibits seem to appear to be references, the title has not even been provided. Without any exhibits, it appears that the affidavit is merely an opinion.
MPEP 716.01(c) states that with respect to opinion testimony that the examiner must consider: “the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion”. In the instant case it appears that the nature of the matter sought is to establish a lack of predictability. The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25. Page 13 lines 6-9 recognizes that “just pointing out differences and that it’s a change in a stereocenter doesn’t provide any scientific discussion or support for why one of ordinary skill would say, oh, that’s a big deal in this kind of molecule”.
With respect to the strength of the opposing evidence, the references used in the 103 rejection are the same references recited in the Examiner’s Answer (1/15/25) which was signed by a supervisory primary examiner and 2 additional primary examiners. The Patent Trial and Appeal Board Hearing Transcript was made of record 10/31/25 and it is noted that page 8 lines 2-8 and lines 17-18 are consistent with the information provided above. In fact, lines 17-18 of page 8 recite “the Examiner has given us evidence of a reasonable expectation of success”.
With respect to interest of the expert, the affidavit is signed by an employee of the applicant who presumably has a vested interest in the outcome of the case. With respect to the presence or absence of factual support, although the affidavit refers to exhibits there are no exhibits of record. Thus there is no bases to conclude markedly superior results.
Further, in referring to exhibit A the affidavit (page 3 3rd line of text) recites ‘Surprisingly’. Although the office takes no official position until the exhibit is provided and made of record, MPEP 2143.02 I recognizes that absolute predictability is not required. The fact that applicants appear to rely on a ‘surprising’ situation would seem to support that in general radioligand binding assays are predictive of activity. Zhang expressly calls the experiments ‘Radioligand Displacement’.
Further, the citation to ‘This is not to imply that the study of isolated receptor proteins is not of value’ (page 4) would seem to be a recognition of their importance.
In addition the reference to a difference in abundance does not necessarily show that the expression location is different (page 5 section 7).
MPEP 2107.03 I recognizes that evidence of pharmacological or other biological activity of compound is relevant to its therapeutic use.
MPEP 2107.03 V recognizes that the office must confine it review to the statutory requirements of the patent law and that determining the degree of effectiveness is not required.
MPEP 2143.02 III recognizes that predictability is determined at the relevant time. It appears that one of the exhibits referred to appears to be from 1986.
The affidavit under 37 CFR 1.132 filed 12/1/25 is insufficient to overcome the rejection of the claim under 103 as set forth above because: MPEP 2143.02 I recognizes that absolute predictability is not required. MPEP 2145 I recognizes that arguments presented by the applicant cannot take the place of evidence in the record. The affidavit refers to exhibits A-F. None of exhibits A-F have been provided.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Double Patenting
The rejection below is a new rejection based on the recent filing of application 19358840.
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, 8-13, 16, 18-19, 55, 61-63, 71, 77, 90, 102, 104, 112 and 119-120 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-89 of copending Application No. 19358840 (reference application; ‘840’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
840 recites a method for treating, preventing, inhibiting, ameliorating or delaying the onset of an ophthalmic disease, disorder or condition in a mammalian subject in need thereof comprising administering a peptidomimetic (claim 1). Claim 5 shows the structure of formula II and claim 6 shows that chemical name for formula II. 840 recites specific conditions including age-related macular degeneration (claim 1). 840 recites that the subject is human (claim 8). 840 recites methods of administering (claims 9-12). 840 recites the inclusion of an additional agent (claims 14-15). 840 recites that the subject has drusen (claim 19). 840 recites various salt forms (claim 16).
In relation to the peptidomimetic of claims 1, 55, 71 and 90, 840 recites a specific peptidomimetic (claims 1 and 5-6). Formula II corresponds to formula II of the instant claims.
In relation to claim 16, 840 recites various salt forms (claim 16).
In relation to the subject of claims 1, 18, 55, 61, 71, 77, 90, 93, 112 and 119, 840 recites specific conditions including age-related macular degeneration (claim 1). 840 recites that the subject is human (claim 8). 840 recites methods of administering (claims 1 and 9-12). 840 recites the inclusion of an additional agent (claims 14-15). 840 recites that the subject has drusen (claim 19). Since 840 teach the elected peptidomimetic it would function as claimed (for example delaying the onset of ellipsoid zone integrity of claims 55 and 77 and 119 and delaying the onset of geographic atrophy of claim 71).
In relation to claims 8 and 62, 840 recites that the subject is human (claim 8).
In relation to claims 9-11 and 63, 840 recites various administration modes (claims 9-11).
In relation to claim 12, 840 recites specific administrations (claim 12).
In relation to claim 13, 840 recites simultaneous administration of an additional agent (claim 13).
In relation to claims 19 and 120, 840 recites that the subject has drusen (claim 19).
In relation to claim 102, 840 recites the inclusion of an additional agent (claims 14-15).
In relation to claim 104, 840 recites cromolyn (claim 15).
Claims 1, 8-13, 16, 18-19, 55, 61-63, 71, 77, 90-94, 96-99, 101-108, 110-112, 115-116 and 118-120 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-89 of copending Application No. 19358840 (840) in view of Wilson et al. (US 2015/0018288; ‘Wilson’; previously cited).
This is a provisional nonstatutory double patenting rejection.
840 recites a method for treating, preventing, inhibiting, ameliorating or delaying the onset of an ophthalmic disease, disorder or condition in a mammalian subject in need thereof comprising administering a peptidomimetic (claim 1). Claim 5 shows the structure of formula II and claim 6 shows that chemical name for formula II. 840 recites specific conditions including age-related macular degeneration (claim 1). 840 recites that the subject is human (claim 8). 840 recites methods of administering (claims 9-12). 840 recites the inclusion of an additional agent (claims 14-15). 840 recites that the subject has drusen (claim 19). 840 recites various salt forms (claim 16).
840 does not recite all the details of claims 91-94, 96-99, 101, 103, 105-108, 110-111, 115-116 and 118.
Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 (abstract) which is also called SS-31 (section 0063) for treating ophthalmic conditions (abstract). Wilson teach administration of a peptide to treat age-related macular degeneration including dry macular degeneration (section 0178). Wilson teach a subject with drusen (section 0209). Wilson teach administration of an effective amount (abstract and section 0001). Wilson teach that the subject is human (section 0008). Wilson teach subcutaneous, intraocular and oral administration (section 0059). Wilson teach administration directly to the eye via eye drops (section 0194). Wilson teach daily dosages (section 0277). Wilson teach an additional therapeutic agent that can be administered simultaneously (section 0009). Wilson specifically recites an antioxidant or anti-inflammatory as a further component (section 0062). Wilson teach that the use of antioxidants have been shown to benefit patients with macular degenerations (section 0285). Wilson teach that macular degeneration is characterized by inflammation (section 0003). Wilson teach that suitable anti-inflammatories include cromolyn (section 0292). Wilson recognizes diseases where there are problems with the retina and refers to oxidative damage (sections 0003-0004). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 prevents oxidative stress in retinal cells (example 5 beginning on page 31) and concludes that peptides of the present technology are useful for the prevention of damage to retinal cells in mammalian subjects in need thereof (section 0342). Wilson teach D-Arg-Dmt-Lys-Phe-NH2 as an antioxidant to reduce photoreceptor cell death (example 8 pages 32-33). Wilson specifically relates the peptide to enhancing or improving mitochondrial function or reducing oxidative damage (sections 0155, 0228 and 0351). Wilson teach that there is mounting evidence that dysfunctional mitochondria are the primary source of reactive oxygen species and the eye is at considerable risk from oxidative stress (section 0155). Wilson recognizes the use of amino acid mimetics (section 0110). Wilson teach ophthalmic delivery (sections 0252-0260). Wilson teach examples with 1% peptide (sections 0302-0303). Wilson teach the inclusion of a buffer (sections 0239-0240 and 0245). Wilson teach the inclusion of water (sections 0239-0241). Wilson teach the peptide D-Arg-Dmt-Lys-Phe-NH2 and applications for any cell, tissue or organ of the central and peripheral nervous system (section 0230).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 840 because Wilson teach administration to the same or similar patient populations (abstract, section 0178) with a similar agent. Since 840 expressly teach various administration modes (claims 9-11) one would have been motivated to prepare for such administration. Wilson teach administration directly to the eye via eye drops (section 0194). Wilson teach examples with 1% peptide (sections 0302-0303). Wilson teach the inclusion of a buffer (sections 0239-0240 and 0245). Wilson teach the inclusion of water (sections 0239-0241). Thus one would have been motivated to include such components in such amounts. Since Wilson teach administration of a peptide to treat age-related macular degeneration including dry macular degeneration (section 0178) one would have been motivated to administer to such subjects. One would have had a reasonable expectation of success since 840 expressly teach for treating ophthalmic diseases (claim 1).
In relation to the peptidomimetic of claims 1, 55, 71 and 90, 840 recites a specific peptidomimetic (claims 1 and 5-6). Formula II corresponds to formula II of the instant claims.
In relation to claim 16, 840 recites various salt forms (claim 16).
In relation to the subject of claims 1, 18, 35, 55, 61, 71, 77, 90, 93, 98, 103, 107, 112 and 119, 840 recites specific conditions including age-related macular degeneration (claim 1). 840 recites that the subject is human (claim 8). 840 recites methods of administering (claims 1 and 9-12). 840 recites the inclusion of an additional agent (claims 14-15). 840 recites that the subject has drusen (claim 19). Wilson teach administration of a peptide to treat age-related macular degeneration including dry age related macular degeneration (section 0178). Wilson teach administration of an effective amount (abstract and section 0001). Since 840 teach the elected peptidomimetic it would function as claimed (for example delaying the onset of ellipsoid zone integrity of claims 55 and 77 and 119 and delaying the onset of geographic atrophy of claim 71).
In relation to claims 8, 62, 108 and 118, 840 recites that the subject is human (claim 8). Wilson teach that the subject is human (section 0008).
In relation to claims 9-11, 63, 91-92, 94 and 96, 840 recites various administration modes (claims 9-11). Wilson teach administration directly to the eye via eye drops (section 0194).
In relation to claim 12, 840 recites specific administrations (claim 12). Wilson recognizes that the schedule of doses can be optimized (section 0237).
In relation to claim 13, 840 recites simultaneous administration of an additional agent (claim 13). Wilson teach an additional therapeutic agent than can be administered simultaneously (section 0009).
In relation to claims 19, 99 and 120, 840 recites that the subject has drusen (claim 19).
Wilson teach a subject with drusen (section 0209).
In relation to claims 97, 101, 105-106, 110-111 and 115-116 Wilson teach examples with 1% peptide (sections 0302-0303). Wilson teach the inclusion of a buffer (sections 0239-0240 and 0245). Wilson teach the inclusion of water (sections 0239-0241).
In relation to claim 102, 840 recites the inclusion of an additional agent (claims 14-15).
Wilson specifically recites an antioxidant or anti-inflammatory as a further component (section 0062).
In relation to claim 104, 840 recites cromolyn (claim 15). Wilson teach that suitable anti-inflammatories include cromolyn (section 0292).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658