Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Office Action is responsive to the After Final Response and Amendment filed 03/27/2026, which amended claims 16, 24-36, 38-39, and 41.
Claims 16-43 are pending.
Prosecution is re-opened. Applicant’s amendment of 11/17/2025 added hereditary fundus dystrophies back to the eye diseases treated in independent claims 16 after it had been deleted in view of a prior art rejection over US 2005/0153936 to Ikonomidou (published 2005, IDS of 11/01/2022). The 11/17/2025 additionally added independent claim 39 which teaches a method of treating any eye disease. In view of these amendments, new prior art rejections are applied.
Additionally, new matter rejections are applied in view of the 02/18/2025 and 11/17/2025 amendments to the claims.
Note: This Application was originally filed by a pro-se inventor on 11/01/2022. On 12/06/2023, a power of attorney was submitted. In view of the application being filed by the pro-se inventor, a summary of claims is being provided.
On 11/01/2022, two original claims sets were filed that appeared to be identical. However, these original claim sets cancelled claims, amended claims, and added claims, which was improper since it was an originally filed claim set. In these claim sets, claims 16-35 were pending.
On 11/27/2022, an additional claim set was filed that was distinct from the two claim sets filed on 11/01/2022. In this claim set, claims 1-15 are pending.
As a result of the above, on 02/15/2023, a notice of non-compliant/non-responsive amendment was mailed to the pro-se inventor.
On 04/05/2023, two claim sets were filed by the pro-se inventor that appeared to be identical. These claim sets properly referred back to the 11/27/2022 claim set. As such, the claims filed on 11/01/2022, were determined to be non-compliant and were not examined. The claims filed on 11/27/2022, were interpreted as the proper claim set which the 04/05/2023 claim set referenced in making amendments to the claims.
See also pg. 2 of the 09/06/2023 “Non-Final Rejection” which summarizes the state of the claims.
Priority
This application claims the following priority:
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Rejections Withdrawn
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(a)-Scope of Enablement
Applicant’s amendments to claim 16 and 39 that add “A method of decreasing apoptosis in retinal ganglion cells for the treatment of an eye disease. . .to a subject in need thereof,” is sufficient to overcome this rejection over claims 16-35 and 39-43.
REJECTIONS-NEW
Claim Objections
(New) Claim 1 is objected to because of the following informalities:
-In the definition of R5 in claim 1, the phrase “phenyloxy-(C1-C6) is substituted with (C1-C6)alkyl or (C1-C6)-alkoxy or halogen, and naphthyl-(C1-C6)-alkyl” should be substituted with - -phenyloxy-(C1-C6)-alkyl substituted with (C1-C6)alkyl, (C1-C6)alkoxy, halogen, or naphthyl-(C1-C6)alkyl- -, for grammatical clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New) Claims 16-18, 22-35, and 39-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
-In claim 16, in the definition of R4 and R6, the recitation “tert-butyl” is new matter.
This amendment to the claim was added on 02/18/2025. On pg. 10, of the 02/18/2025, Remarks, Applicant states that support for the amendments to the claim set can be found in the original claims as filed, in paragraphs 3-6, 15, 21-23, and 30-32 of the specification, and in Table 1.
However, a careful review of the original disclosure and the specified paragraphs, and table, does not provide support for R4 and R6 are independently “tert-butyl.”
The originally filed claims and [0023] of the specification do provide support for R4 is tert-butyl, in view of the teaching of:
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, but this species does not provide support for R6 is tert-butyl.
-In claim 39, in the definition of R5, the recitation of “naphtyl-(C1-C6)-alkyl” is new matter.
Claim 39 was added by the 11/17/2025 amendment to the claims. On pg. 12, of the 11/17/2025, Remarks, Applicant states that support for the amendments to the claim set can be found in the original claims as filed, in paragraphs 3-6, 15, 21-23, and 30-32 of the specification, and in Table 1.
However, a careful review of the original disclosure and the specified paragraphs, and table, does not provide support for “naphtyl-(C1-C6)-alkyl.”
The originally filed claims and [0023] of the specification do provide support for naphthyl-(CH2)2 in view of the teaching of:
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, but this species does not provide support for “naphtyl-(C1-C6)-alkyl,” as recited in claim 39.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(d)
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.
(New) Claim 20 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 20 depends from claim 16 and depicts the following compound as a compound of formula (I):
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However, claim 16 defines R5 as:
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.
As such, the structural depiction of R5 as naphthyl-(CH2)2, in claim 20 is outside the scope of the definition of R5 in claim 16, and therefore fails to further limit the subject matter of claim 16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(Modified) Claims 36-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of decreasing apoptosis in retinal ganglion cells for the treatment of an eye disease by administering
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, does not reasonably provide enablement for a method preventing an eye disease by administering any compound of instant formula (I).
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
Independent claim 36 is directed toward a method of decreasing apoptosis in retinal ganglion cells for the prevention and/or treatment of any glaucoma, any acquired macular disorders, any optic neuropathy, any optic neuritis, any uveitis, any retinal vascular diseases, any scleritis, any episcleritis, any retinal detachments, any trauma to eye globe, any vitreous opacities, any myopia, any degenerative myopia, any postsurgical trauma, any dry eye disease, and any corneal disorders, by administering a therapeutically effective amount of
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Thus, the claims encompass a method of preventing or treating a plethora of disparate eye diseases by administering a single compound.
The breadth of the claims is large.
Level of Skill in Art
The level of skill in the art is a clinician or an individual with a PhD.
State of the Prior Art
Waldeck (US 5,677,297, 1997, PTO-892 of 09/06/2023) teaches compounds of instant formula (I) as compounds having neutral endopeptidase (NEP) inhibitor activity and endothelin-converting enzyme (ECE) inhibitory activity (Col. 14, lines 5-56; Col. 16). Waldeck teaches these compounds for the treatment of heart failure (Col. 1, lines 25-35.
Ikonomidou (US 2005/0153936, published 2005, IDS of 11/01/2022) teaches compounds of instant formula (I), wherein these compounds have neutral endopeptidase (NEP) and/or human soluble endopeptidase (hSEP) inhibitor activity. Ikonomidou teaches these compounds of the treatment of disparate neuromuscular disease, wherein Ikonomidou only teaches the treatment of a single eye neuromuscular disease, retinal pigmentosa (pgs. 5-6, claims 1-8; [0038]).
Thus, while the prior art teaches the instantly claimed compounds, these compounds are taught for the treatment of heart failure and neurodegenerative disorders, wherein a single eye disease is taught as one of recited, disparate neurodegenerative diseases.
As reflected in the title of the instant invention and the teaching of the specification, the instantly claimed compounds are dual inhibitors of endothelin converting enzyme-1 (ECE-1), and neutral endopeptidase (NEP) and/or human soluble endopeptidase (hSEP) ([0001], specification).
Rosenthal (Endothelin antagonism as an activity principle for glaucoma therapy, BJP, published 2010, IDS of 11/01/2022) teaches that endothelin, the most potent vasoactive peptide known to date, has been suggested to play a potential role in the pathogenesis of open angle glaucoma since inhibition of endothelin signaling leads to lowering intraocular pressure and exerting neuroprotective effects (abstract). However, Rosenthal teaches endothelin antagonists as causing major birth defects, liver toxicity, headache, nasopharyngitis, and peripheral oedema, wherein these side effects may prevent the development of endothelin receptor antagonists for glaucoma therapy (pg. 809, Col. 1, 1st full paragraph). Thus, Rosenthal teaches endothelin antagonists as a possible treatment for glaucoma, wherein the development of the treatment may be prevented by the side effects of such antagonists.
Good (The role of endothelin in the pathophysiology of glaucoma, Exper Opin Ther Targets, published 2010, IDS of 11/01/2022) teaches that targeting the endothilin-1 pathway shows promise as a target for glaucoma treatment and that “Future studies should focus on better defining the role that ET-1 plays in normal ocular physiology and how this pathway might be altered in eyes with glaucoma. More preclinical studies should be carried out to better quantify the effects of various endothelin related medications on the eye. The new knowledge obtained from these studies could lead to a new class of medication that can aid in the fight against vision loss” (abstract; pg. 652, “5.”). Thus, Good teaches that targeting the endothelial-1 pathway may provide a new therapeutic option for treating glaucoma, but that future study is required to determine if this is a possibility.
McGrady (Upregulation of the endothelin A (ETA) receptor and its association with neurodegeneration in a rodent model of glaucoma, BMC Neuroscience, published 2017, PTO-892) teaches that “While it is evident that the endothelin receptors are upregulated during IOP elevation, some questions still need to be addressed in the future. One such question is how does an increase in IOP lead to elevated endothelin levels and increased endothelin receptor expression? The second question that still remains to be answered is what pathways are involved during endothelin receptor mediated neurodegeneration?. . . .Assessment of the contribution of both endothelin receptors to glaucomatous neurodegeneration provides a good rationale for developing endothelin antagonists as neuroprotective agents for the treatment of glaucoma.”
Thus, while the prior art teaches the endothelin pathway as a pathway involved in glaucoma and states that endothelin antagonists may be a future treatment, a method of treating glaucoma by administering endothelin pathway inhibitors/antagonists is not taught in the prior art.
NIH (National Eye Institute, Glaucoma, PTO-892) teaches that there is no way to prevent glaucoma (pg. 2, “What causes glaucoma?”).
The prior art does not teach administering dual inhibitors of ECE-1 and NEP/hSEP for the prevention of glaucoma, acquired macular disorders, optic neuropathy, optic neuritis, uveitis, retinal vascular diseases, scleritis, episcleritis, retinal detachments, trauma to eye globe, vitreous opacities, myopia, degenerative myopia, postsurgical trauma, dry eye disease, and corneal disorders.
Predictability in the Art
In view of the above teachings of the prior art, it is not predictable to prevent glaucoma, or acquired macular disorders, optic neuropathy, optic neuritis, uveitis, retinal vascular diseases, scleritis, episcleritis, retinal detachments, trauma to eye globe, vitreous opacities, myopia, degenerative myopia, postsurgical trauma, dry eye disease, and corneal disorders, with dual inhibitors of ECE-1 and NEP/hSEP, such as the compounds of instant formula (I).
While the prior art teaches that it is known that the endothelin pathway plays a role in the pathogenesis of glaucoma, treating glaucoma with inhibitors of this pathway, is not known, and not predictable; all of the referenced prior art publications state that future studies are required.
Working Examples
The instant specification provides a single example. Rats are administered either a vehicle or the compound of example (6),
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and then administered doxorubicin, an apoptosis agent, and then euthanized to visualize apoptosis in the liver and eyes. The results show that doxorubicin causes apoptosis in the liver and retina and that the compound of example (6) confers protection against doxorubicin, as shown by Table 1:
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However, the instant specification provides no correlation between decreasing apoptosis by ~8% with the compound of example (6), and treating any disease, much less those recited in independent claims 16 and 36.
Moreover, Xia (Apoptosis in glaucoma: A new direction for the treatment of glaucoma, Molecular Medicine Reports, published 2024, PTO-892), published in 2024, teaches that currently, surgical intervention with medication as an adjunct, is the most promising treatment for glaucoma. Xia teaches that “Among drugs and gene therapies, targeting apoptosis is feasible in animal models and preclinical experiments. However, further proof of the feasibility of treatment is needed. .. there are several remaining problems, for example. . .How can the effect of existing drugs or gene therapy on the inhibition of apoptosis last longer and be more stable? Iv) How can the balance between proapoptotic and antiapoptotic signals be addressed? Future research will combine mechanism based assays with improved detection methods to further explore changes in apoptotic proteins and their interrelationships and identify targets for inhibiting cell apoptosis.”
Thus, preventing eye diseases by inhibiting apoptosis is unpredictable in the art and requires future study to arrive at effective methods of treatment.
Direction and Guidance
Since the specification provides only a single example, wherein this example merely shows a slight decrease in apoptosis in retinal ganglion cells with a single compound, the specification provides no guidance or direction as to how to prevent glaucoma, acquired macular disorders, optic neuropathy, optic neuritis, uveitis, retinal vascular diseases, scleritis, episcleritis, retinal detachments, trauma to eye globe, vitreous opacities, myopia, degenerative myopia, postsurgical trauma, dry eye disease, and corneal disorders, by administering a therapeutically effective amount of
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Quantity of Experimentation
The quantity of experimentation required to determine which compounds of formula (I) prevent glaucoma, acquired macular disorders, optic neuropathy, optic neuritis, uveitis, retinal vascular diseases, scleritis, episcleritis, retinal detachments, trauma to eye globe, vitreous opacities, myopia, degenerative myopia, postsurgical trauma, dry eye disease, and corneal disorders, and all the species of the these disease, would be astronomical.
While the instant specification provides support for a method of decreasing apoptosis in retinal ganglion cells by administering
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, it is not enabled for a method of preventing glaucoma, acquired macular disorders, optic neuropathy, optic neuritis, uveitis, retinal vascular diseases, scleritis, episcleritis, retinal detachments, trauma to eye globe, vitreous opacities, myopia, degenerative myopia, postsurgical trauma, dry eye disease, and corneal disorders, by administering a compound of formula (I):
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Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-23, 39-40, and 42-43 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2005/0153936 to Ikonomidou (published 2005, IDS of 11/01/2022).
Ikonomidou teaches a novel use of known benzazepine, benzoxazepine, benzo-thiazepine-N-acetic acid and phosphono-substituted benzazepinone derivatives having neutral endopeptidase (NEP) and/or human soluble endopeptidase (hSEP) inhibitor activity. These compounds are useful for the preparation of pharmaceutical compositions for prophylaxis and treatment of neurodegenerative disorders (abstract).
The compounds of the claims of Ikonomidou are identical to those of instant formulas (1), (3), (4), (5), (6), (7) and (8) (paragraphs 6-25; pgs. 5-6—claims 1-6), wherein the compounds of Ikonomidou ‘936 share the same labels as those claimed, i.e., compound (1) of Ikonomidou corresponds to instant compound (1), etc.
Calcium salts of the above compounds are taught as an acceptable and preferable salt form (pg. 6—claim 7).
Retinitis pigmentosa is taught as a neurodegenerative disorder that is treated with the compounds (paragraph 38, pg. 6—claim 8).
As evidenced by page 4 of the specification, retinitis pigmentosa is a hereditary fundus dystrophy.
Regarding the phrase “decreasing apoptosis in retinal ganglion cells,” in the preamble of the independent claims, Applicant is reminded that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Though Ikonomidou does not explicitly teach “decreasing apoptosis in retinal ganglion cells,” it is reasonable to assume that the composition comprising the compounds of instant formula (I) would have the same properties since they are administered for the same purpose (to treat retinitis pigmentosa, a hereditary fundus dystrophy) in amounts effective to treat the retinitis pigmentosa, to the same population (patients with retinitis pigmentosa), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties. See also MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16-23, 29, 39-40, and 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0153936 to Ikonomidou (published 2005, IDS of 11/01/2022) in view of NIH (About Retinitis Pigmentosa, PTO-892).
Ikonomidou is applied to claims 16-23, 39-40, and 42-43, as discussed above and incorporated herein.
While Ikonomidou teaches a method of treating retinitis pigmentosa by administering the instantly claimed compounds, it differs from that of the instantly claimed invention in that it does not teach treating cone-rod dystrophy.
NIH teaches that most forms of retinitis pigmentosa cause the breakdown of rod cells and that these forms of retinitis pigmentosa are called rod-cone dystrophy (pg. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the methods of Ikonomidou to treat the rod-cone dystrophy of retinitis pigmentosa, to arrive at instant claim 29. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Ikonomidou teaches a method of treating retinitis pigmentosa, and
-NIH teaches that most forms of retinitis pigmentosa cause the breakdown of rod cells and that this type of retinitis pigmentosa is called rod-cone dystrophy.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method of treating rod-cone dystrophy of retinitis pigmentosa.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-27, 29-31, and 36-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, and 10 of copending Application No. 19/244,974 (claim set dated 06/20/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘974 claims compounds of instant formulas (1), (2), (3), (4), (5), (6), (7), and (8) (claims 1, 3-7).
‘974 claims salts of these compound and specifically teaches a calcium salt (claim 8).
‘974 claims these compounds for use in treating the instantly claimed diseases of the eye of claims 16, 24-27, 29-31, 35-36, and 39 (claims 1, 10).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
[0028] of the instant specification teaches administration of 60mg/kg/day of the instantly claimed compounds.
Regarding the phrase “decreasing apoptosis in retinal ganglion cells,” this phrase occurs in the preamble of the independent claims. Applicant is reminded that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Though ‘974 does not explicitly teach “decreasing apoptosis in retinal ganglion cells,” it is reasonable to assume that the composition comprising the compounds of instant formula (I) would have the same properties since they are administered for the same purpose (to treat the instantly claimed eye diseases) in amounts effective to treat the instantly claimed eye diseases, to the same population (patients with the instantly claimed eye diseases), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties. See also MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Free of the Prior Art
Claims 24-28, 30-38, and 41 are free of the prior art.
The closest prior art is US Patent No. 2005/015936 to Ikonomidou (IDS of 11/01/2022) which teaches compounds of instant formula (I), wherein these compounds have neutral endopeptidase (NEP) and/or human soluble endopeptidase (hSEP) inhibitor activity. Ikonomidou teaches these compounds as useful for the prophylaxis and treatment of neurodegenerative disorders (abstract), such as the eye disease retinitis pigmentosa.
The reference does not teach a method of decreasing apoptosis in retinal ganglion cells for the treatment of glaucoma, acquired macular disorders, optic neuropathy, optic neuritis, uveitis, retinal vascular diseases, scleritis, episcleritis, retinal detachments, trauma to eye globe, vitreous opacities, myopia, degenerative myopia, postsurgical trauma, dry eye disease, and corneal disorders, to subjects in need thereof, which are the distinct features of the instantly claimed method.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622