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 .
Formal Matters
Claims 51-70 are pending.
Election/Restrictions
Applicant’s election without traverse of ACE inhibitors and the species ramipril in the reply filed on 08/26/2025 is acknowledged.
Claim 55 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of vasodilator, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2025.
Priority
This application is a continuation of U.S. National Phase of International No. PCT/US2023/034581, filed October 5, 2023, and claims the benefit of U.S. Provisional Application No. 63/378,718, filed October 7, 2022.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed 09/04/2025 has been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
Lined-through references fail to comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609 because they do not satisfy the stipulations of 37 C.F.R. 1.98(a) and/or §1.98(b) regarding the citation of non-patent literature. 37 C.F.R. §1.98(b) explicitly states that “[e]ach publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date and place of publication”. Applicant’s cited non-patent literature reference 111 in the IDS filed 09/04/2025 has been lined-through for failing to provide the relevant information, i.e., date of publication, required by 37 C.F.R. §1.98(b) and MPEP §609.04(a)(1).
As such, the document has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 C.F.R. §1.97(e). MPEP §609.05(a).
Claim Rejections - 35 USC § 112(b)
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 61-62 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 61 recites the limitation "wherein the concentration of the vasodilator is about 0.0001 mg per ml to 1000 mg per ml" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 61 depends from claim 53, which recites “a composition comprising at least one vasodilator” and “at least one pharmaceutical excipient”. It does not, however, require that the composition is liquid such that it would have a “concentration” where the vasodilator amount would be expressed in “mg per ml”.
Claim 62 recites the limitation "wherein the concentration of the vasodilator is about 0.0001% by weight to about 20% by weight" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 62 depends from claim 53, which recites “a composition comprising at least one vasodilator” and “at least one pharmaceutical excipient”. It does not, however, require that the composition is liquid such that it would have a “concentration” where the vasodilator amount would be expressed in “% by weight”. Additionally, it is unclear what weight the percent is in relation to.
Claim Rejections - 35 USC § 112(a) (Enablement)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 51-54 and 56-68 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 treating or reducing glaucoma in a patient in need thereof comprising topical administration to the eye or intravitreal or intraocular injection to the eye of a patient, does not reasonably provide enablement for preventing or prophylaxis of glaucoma and/or treating or reducing glaucoma in a patient in need thereof comprising other administration routes. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, and breadth of the claims
The claims encompass preventing and prophylaxis – also interpreted as prevention - of glaucoma comprising the administration of a composition comprising a vasodilator to a patient “in need thereof”. Although the prior art contains documentation of the use of vasodilators such as ACE inhibitors to treat glaucoma in patients, the prior and contemporaneous art lacks documentation of preventing/prophylaxis of glaucoma.
The state and predictability of the art, and relative skill of those in the art
Regarding preventing/prophylaxis of glaucoma, the level of predictability is low because there is no known therapeutic that can prevent glaucoma.
The prevention/prophylaxis of glaucoma is not considered enabled. No compound (let alone a genus of compounds as broad as that presently claimed) has ever been found that can prevent glaucoma, even though massive efforts have been directed towards this end. Since this assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits. A compound effective in preventing glaucoma would be a revolutionary exception. Applicant is asserting that he succeeded where others have failed. Where extensive efforts have all failed, it is reasonable for the Patent and Trademark Office to require proof that the claimed invention actually works for this specific utility. It is well established that a utility rejection is proper when scope of enablement is not reasonably correlated to the scope of the claims. (In re Vaeck 20 USPQ2d 1439, 1444, In re Ferens 163 USPQ 609).
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.), Nationwide Chemical Corporation, et al. v. Wright, et al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances), Ex parte Sudilovsky 21 USPQ 2d 1702 (Appellant's invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable) In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian recombinant virus vaccine was uncertain). As long as the Specification discloses at least one method of making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112, 1st Paragraph is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). To that extent, if little is known in the prior art about the nature of the invention and the art is unpredictable, the Specification would need more detail as to how to make and use the invention in order to be enabling. See Chiron Corp v. Genetech, lnc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) ("Nascent technology, however, must be enabled with a specific and useful teaching. The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.")
Here, as will discussed in detail below, the Specification provides absolutely no direction, examples, or guidance concerning effective prevention of glaucoma in patients. Given the complete lack of any evidence, either in the disclosure or the prior and contemporaneous art, that pharmaceuticals can prevent glaucoma, such prevention is completely unpredictable and not believable.
The amount of direction or guidance provided and the presence or absence of working examples
As discussed above, the Specification provides absolutely no direction, examples, or guidance concerning effective prevention of glaucoma in patients. The Specification further only provides direction or guidance for topical administration to the eye of a patient or intravitreal or intraocular injection to the eye of a patient. All of the examples proffered by Applicant relate to patients “diagnosed with glaucoma”, i.e., treatment of already existing glaucoma.
The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept the assertion that vasodilators could be predictably used as a prevention/prophylaxis for glaucoma as inferred in the claims and contemplated by the specification.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997).
In the instant case, Applicant has presented a general idea that because some vasodilators administered via intravitreal or intraocular injection to the eyes of patients having existing glaucoma are observed to have reduced symptoms of glaucoma they must therefore, a priori, be useful in the prevention/prophylaxis of glaucoma. However, just because a pharmaceutical is effective in treating a disease/disorder does not mean it will also be effective in preventing that disease/disorder. If such were the case, virtually all diseases/disorders would be preventable because there are therapeutically effective treatments for the vast majority of diseases/disorders. In this case, there is no known pharmaceutical that can prevent glaucoma.
Determining if any particular vasodilator would be effective to prevent glaucoma in a patients would require subjecting it to clinical trials that follow the patient for virtually their entire lifetime in order to demonstrate that the patient never develops glaucoma. This is undue experimentation given the complete lack of any guidance and direction provided by Applicant for such prevention and the complete lack of any factual evidence that vasodilators are effective to prevent glaucoma in patients.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
Claim(s) 51-53, 57, and 63-64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CONSTAGLIOLA ET AL. (Eur. J. Ophthalmol., 1995, vol. 5, no. 1, p.19-25) (ABSTRACT Attached).
Regarding claims 51-53, 57, and 63-64, CONSTAGLIOLA ET AL. teach orally administering 25 mg of the ACE inhibitor captopril to 20 patients having primary open angle glaucoma (Abstract).
Claim(s) 51-53, 57, 59-64, and 67-69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHISELITA ET AL. (Oftalmologia, 1996, vol. 40, no. 1, p.18-25) (ABSTRACT Attached).
Regarding claims 51-53, 57, 59-64, and 67-69, CHISELITA ET AL. teach administering an isotonic solution comprising 2.5% of the ACE inhibitor captopril to 18 patients having primary open angle glaucoma via ocular instillation 4 times/day (Abstract).
Claim(s) 51-53, 57, and 63-64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by REKIK ET AL. (Journal Francais d’ophtalmolgie, 2002, vol. 25, no. 4, p.357-365) (ABSTRACT Attached).
Regarding claims 51-54 and 56-57, REKIK ET AL. teach orally administering 1.25 mg of the ACE inhibitor ramipril to 22 patients suffering from chronic glaucoma (Abstract).
Claim(s) 51-52, 57, and 64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HIROOKA ET AL. (Am J Ophthalmol, 2006, 142:523–525).
Regarding claims 51-52, 57, and 64, HIROOKA ET AL. teach ACE inhibitors have been shown to lower intraocular pressure (IOP) in patients with ocular hypertension or primary open-angle glaucoma (p.523, right column, 1st paragraph). They teach patients with normal-tension glaucoma (NTG) were administered ACE inhibitors (p.523, right column, 2nd paragraph; Table 1).
Claim(s) 51-54, 56-57, and 63-64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KRASINSKA ET AL. (Blood Pressure, 2012, vol. 21, p.240-248).
Regarding claims 51-54, 56-57, and 63-64, KRASINSKA ET AL. teach patients with primary open-angle glaucoma and controlled hypertension were administered the ACE inhibitor ramipril (5 or 10 mg) (Abstract; p.241-242, “Patients”; Table I).
Claim(s) 51-52, 56-57, 59-62, and 68-69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AU40288/85 (Published Sept. 26, 1985).
Regarding claims 51-52, 56-57, 59, and 69, AU40288/85 teaches a method for the treatment of glaucoma and/or the reduction of intraocular pressure in mammals by topical or systemic administration of inhibitors of ACE of formula I (Claim 1; p.2, l.1 to p.3, l.25). Regarding claims 60 and 68, the compounds suitable for the use according to the invention
are incorporated in pharmaceutical products for administration, such as capsules, tablets, coated tablets, solutions, ointments and emulsions, as well as into depot form (p.15, l.14-19). Regarding claims 61-62, topical administration forms can contain 0.001-5% by weight of the ACE inhibitor and 0.001-5 mg or 0.0005-1.0 mg and, in particular, 0.001-1.0 mg of the ACE inhibitor are used on the human eye (p.15, l.31-32 & l.34-36)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 51-54, 56-57, and 59-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,426,394.
Although the claims at issue are not identical, they are not patentably distinct from each other because the “preventing” and “prophylaxis” embodiments of the claims encompass administering the claimed composition to any patient, i.e., all patients are in need of preventing glaucoma. As such, because the ‘394 patent claims topically administer an effective amount of a pharmaceutical composition comprising at least one vasodilator and at least one pharmaceutical excipient to a patient, claims 51, 57, and 63-67 are anticipated by claim 1 of the ‘394 patent.
Regarding claim 52, claim 6 of the ‘394 patent recites that the at least one vasodilator is an ACE inhibitor.
Regarding claims 53-54, 56 and 70, the only ACE inhibitors disclosed in the ‘394 patent for use therein include ramiprilat and ramipril, making their selection prima facie obvious.
Regarding claims 59-60 and 68-69, the ‘394 patent recites topical administration and recites the composition comprises gels, drops, sprays, liquids, ointments, creams, emulsions, and aerosols (‘394 patent claims 1 and 5).
Regarding claims 61-62, the ‘394 patent discloses pharmaceutical compositions for use in the disclosed and claimed invention have concentrations of the vasodilator of about 0.0001 mg per ml to 1000 mg per ml or 0.0001% by weight to about 20% by weight.
Claims 51-54, 56-57, 59-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 17/897,503 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the co-pending claims encompass administering an effective amount of a pharmaceutical composition comprising at least one vasodilator and at least one pharmaceutical excipient to a subject. The intended use of such administration, i.e., treatment of diabetic retinopathy does not distinguish the claims as the “preventing” and “prophylaxis” embodiments of the instant claims encompass administration to any and all patients. Instant claims are essentially the same as copending claims as follows:
Regarding instant claims 51 and 69, copending claims 21 and 40, recite methods comprising topically administering an effective amount of a pharmaceutical composition comprising at least one vasodilator and at least one pharmaceutical excipient to patient in need thereof.
Regarding instant claims 52-54 and 70, copending claims 26-26 and 35-36 recite the vasodilator is an ACE inhibitor that is selected from the group consisting of benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, ramiprilat, or trandolapril.
Regarding instant claim 56, copending claim 31 recites a method to increase blood supply and capillary network to the eye (macula) of the patient.
Regarding instant claims 59-60 and 68, copending claim 31 recites the composition comprises gels, drops, sprays, liquids, ointments, creams, emulsions, or aerosols.
Regarding instant claims 61-62, the copending application discloses pharmaceutical compositions for use in the disclosed and claimed invention have concentrations of the vasodilator of about 0.0001 mg per ml to 1000 mg per ml or 0.0001% by weight to about 20% by weight.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 51-54, 56-57, 59-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 31-33, 35, 37-39, and 41-48 of copending Application No. 19/200,045 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the co-pending claims encompass administering an effective amount of a pharmaceutical composition comprising at least one vasodilator and at least one pharmaceutical excipient to a subject. The intended use of such administration, i.e., treatment of diabetic retinopathy does not distinguish the claims as the “preventing” and “prophylaxis” embodiments of the instant claims encompass administration to any and all patients. Instant claims are essentially the same as copending claims as follows:
Regarding instant claims 51 and 69, copending claims 27 and 35, recite a method comprising administering an effective amount of a pharmaceutical composition comprising at least one vasodilator and at least one pharmaceutical excipient to patient in need thereof.
Regarding instant claims 52-54, copending claims 43 and 46 recite the vasodilator is an ACE inhibitor.
Regarding claims 53-54 and 70, copending claims 44-45 and 47-48 recite the ACE inhibitor is benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, ramiprilat, or trandolapril.
Regarding instant claim 56, copending claims 33 and 39 recites a method to increase blood supply and capillary network to the eye of the patient.
Regarding instant claims 59-60, copending claims 31-32, 37-38, and 41-42 recite the composition comprises oil, liquid, and a suspension, in a form for direct administration to the vitreous tissue of the eye.
Regarding instant claims 61-62, the copending application discloses pharmaceutical compositions for use in the disclosed and claimed invention have concentrations of the vasodilator of about 0.0001 mg per ml to 1000 mg per ml or 0.0001% by weight to about 20% by weight.
Regarding instant claim 67, copending claims 31 and 37 recites a method comprising: topically administering an effective amount of a pharmaceutical composition comprising at least one vasodilator and at least one pharmaceutical excipient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.