DETAILED ACTION
Examiner acknowledges receipt of the reply filed 7/6/2026, in response to the non-final office action mailed 2/4/2026.
Claims 71-91 are pending. Claims 81-91 are newly added.
Claims 71-91 are being examined on the merits in this office 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 .
Claim Objections- withdrawn
The objection of claims 71, 74-77, 79, and 80 is withdrawn in view of the amendment filed 7/6/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claim 78 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 7/6/2026.
Claim Rejections - 35 USC § 102- withdrawn
The rejection of claim 78 under 35 U.S.C. 102(a)(1) as being anticipated by Penfold (WO 2015/089559- previously cited; hereinafter “Penfold ‘559”), is withdrawn in view of the amendment filed 7/6/2026. Claim 78 is incorporated into the 103 rejection in view of the amendment filed 7/6/2026.
Response to Arguments
Applicant’s arguments filed 7/6/2026 with respect to the above objections and rejections, have been fully considered and are persuasive. The objections and rejections have been withdrawn.
Applicant's arguments filed 7/6/2026 have been fully considered with respect to the maintained rejections but they are not persuasive for the reasons set forth herein.
Upon further consideration, a new ground(s) of rejection is made in view of the teachings of the cited references and applicant’s arguments relating to therapeutically effective amount.
An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim interpretation
Examiner notes that the as-filed specification states:
[0004] However, Singh states that AREDS failed to show that vitamin supplementation decreased progression to geographic atrophy (GA). GA is an advanced form of AMD that can result in the progressive and irreversible atrophy of retina (photoreceptors, retinal pigment epithelium (RPE) and choriocappillaris). The pathogenesis of GA is multifactorial and is thought to be triggered by intrinsic and extrinsic stressors of the poorly regenerative RPE. The regions of atrophy can look like a map, this explains the term “geographic”. The term GA is used interchangeably with the term “dry AMD”. …
[0043] While not wanting to be bound by any one theory, the inventor hypothesizes that in dry AMD macrophages enter a cleavage plane between the basement membrane of the RPE and the Brook's membrane, which includes the basement membrane of the choroid, and resulting inflammation peels back the RPE. In many instances the chronic inflammatory cells become established between the basement membrane of the RPE and the choroid. Because a low grade chronic inflammatory process exacerbates and expands the GA lesion (the natural end stage of dry AMD in the absence of neovascularization), the inventor realizes that fludrocortisone is indicated for end stage dry AMD along with TA or other anti-inflammatories.
[0045] In a particular embodiment of any one of the above aspects, the pharmaceutical composition or one or more component thereof may be sterilized. In one embodiment of any one of the above aspects, dry AMD comprises early AMD and geographic atrophy (GA), distinct from exudative AMD.
[0060] As used herein Dry AMD includes Geographic Atrophy (GA). GA may also be known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, which is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina (photoreceptors, RPE and choriocappillaris). Herein "dry AMD" is used to refer to dry AMD, GA and atrophic AMD. In one embodiment as used herein dry AMD comprises early AMD and geographic atrophy (GA), distinct from exudative AMD.
[0064] The inventor recognizes that the dry lesion of dry AMD is regarded as the natural end stage of Macular Degeneration in the absence of neovascularization. This means that in a significant number of cases the eye is dry rather than wet.
Thus, the specification indicates that geographic atrophy and end stage of Macular Degeneration in the absence of neovascularization are the same thing.
New objections and Rejections
Claim Objections- New
Claims 81, 90, and 91 are objected to because of the following informalities:
Claim 81 should be amended to recite “pharmaceutical composition includes 1 mg / 0.1 mL or [[to]] 2 mg/ 0.1 mL”.
Claim 90 should be amended to recite “has a pH from
Claim 91 should be amended to recite “.
Appropriate correction is required.
Please correct concentrations values [spacing] in claims 78, 81-83, and 91 for consistency. Compare claims 81 and 83.
Claim Rejections - 35 USC § 112- New
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.
Claims 81 and 91 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 rejection necessitated by the amendment filed 7/6/2026.
New claims 81 and 91 constitute new matter.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 81 is drawn to a pharmaceutical composition for treating geographic atrophy in a subject, the pharmaceutical composition comprising a therapeutically effective amount of fludrocortisone, fludrocortisone acetate, or fludrocortisone acetonide; and a pharmaceutically acceptable carrier, diluent, or excipient, wherein the pharmaceutical composition includes 1 mg / 0.1 mL to 2 mg/ 0.1 mL of the fludrocortisone, fludrocortisone acetate, or fludrocortisone acetonide.
Claim 91 is drawn to a composition for treating geographic atrophy in a subject, the composition comprising: greater than or equal to 1 mg / 0.1 mL to less than or equal to 2 mg/ 0.1 mL of a mineralocorticoid selected from the group consisting of a fludrocortisone, fludrocortisone acetate, fludrocortisone acetonide, or any combination thereof; and a pharmaceutically acceptable carrier, diluent, or excipient, the composition having a pH greater than or equal to 6 to less than or equal to 8.
Assessment of whether species are disclosed in the original specification
Examiner first notes that that the written description inquiry is limited to that which is contained within the four corners of the specification, not the extent to which the skilled artisan, given his or her knowledge of the art, would have considered it to expand with only routine experimentation. See Ariad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010); see also id. at 1352 (“[I]t is the specification itself that must demonstrate possession. . . . a description that merely renders the invention obvious does not satisfy the requirement.").
The specification does not explicitly or implicitly teach a range of fludrocortisone concentrations spanning 1 mg/0.1 mL to 2 mg/0.1mL. This is equivalent to 10mg/mL to 20 mg/mL, or 10-20mg/mL.
In each instance, the concentration is limited to single dosage points:
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Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, the genus encompassed by the instant claims constitutes new matter. The claim limitation of the instant claims is deemed to be broader in scope than what is actually taught and disclosed in the specification.
Accordingly, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Maintained Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 71-73, 76, 77, 79, 80, 84, 85,and 88-90 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Penfold (WO 2015/089559- previously cited; hereinafter “Penfold ‘559”). The cited reference Penfold is by the inventor of the instant application. The rejection is maintained from the office action mailed 2/04/2026, but has been amended to reflect claims filed 7/06/2026.
Penfold ‘559 teaches pharmaceutical composition comprising a therapeutically effective amount of one or more compounds capable of modulating an activity of a mineralocorticoid receptor and/or a glucocorticoid receptor. The receptor modulators are preferably chosen from triamcinolone acetonide, triamcinolone, fludrocortisone or a therapeutically active analogue, derivative, homolog, pharmaceutically acceptable salt or conjugate thereof. The pharmaceutical compositions further comprise a pharmaceutically acceptable carrier, diluent or excipient (e.g., abstract, paras. [0050]-[0053], [0083], [0112]-[0117], [0124]-[0127], [0141], claims 1-6, 13, 16, 20-21, 30, 31; BSS, saline). The figures and examples disclose assessment of pharmaceutical compositions comprising fludrocortisone and saline (e.g., Fig 1, paras. [0125]-[0144]).
Penfold ‘559 teaches a method of treating macular degeneration including [dry] age-related macular degeneration and wet age related macular degeneration comprising administration of fludrocortisone acetate (paras. [0008]-[0013], [0041], [0046], [0072]-[0073], [0083]-[0084]; claims 5, 20, and 25). Paragraph [072] states: as used herein, the term "eye disease" includes any eye disease such as, macular degeneration, maculopathy including an age related maculopathy (ARM), age related macular degeneration (AMD) including both the dry (geographic atrophy) and wet (choroidal neovascularization (CNV)), …”. The instant specification states that dry AMD comprises early AMD and geographic atrophy (GA) (paras. [0045] and [0060]. Para. [0106] and claim 21 teach a composition comprising triamcinolone acetonide and fludrocortisone acetate. Claim 25 of Penfold ‘559 recites the method, composition, use or syringe of any previous claim (e.g., claim 21) where said eye disease and/or condition is macular degeneration including age-related macular degeneration. The instant specification states that dry AMD comprises early AMD and geographic atrophy (GA) (paras. [0045] and [0060].
Penfold ‘559 states that "effective amount" refers to an amount of an agent or medicament, either in a single dose or as part of a series, which is effective for treating or preventing an eye disease or condition or predisposition thereto. This would include an amount that is effective in achieving a reduction in one or more symptom as compared to baseline prior to administration of such amount as determined, e.g., by visual acuity or other testing. The effective amount will vary depending upon the health and physical condition of the individual to be treated, the taxonomic group of individual to be treated, the formulation of the composition, the assessment of the medical situation, and other relevant factors, it is expected that the amount will fall in a relatively broad range that can be determined through routine trials (para. [0083]). Penfold teaches that the composition can be directly injected into an eye (title, paras. [0068], [0111], [0136], [0147]-[0148]). Claims 16-21 recite administration of fludrocortisone acetate or a therapeutically active analogue, derivative, homolog, pharmaceutically acceptable salt or conjugate thereof. Claim 21 expressly recites a combination of fludrocortisone triamcinolone.
With respect to the limitation in the preamble of claim 71, “for treating geographic atrophy in a subject”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the composition. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
MPEP § § 2112- 2112.02 states that when a reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant, as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' “therapeutically effective amount” differs, and if so to what extent, from the amounts discussed in Penfold ‘559. Penfold ‘559 states: The "effective amount" refers to an amount of an agent or medicament, either in a single dose or as part of a series, which is effective for treating or preventing an eye disease or condition or predisposition thereto. This would include an amount that is effective in achieving a reduction in one or more symptom as compared to baseline prior to administration of such amount as determined, e.g., by visual acuity or other testing (para. [083]).
The cited art taken as a whole demonstrates a reasonable probability that the therapeutically effective amounts within the teachings of Penfold ‘559 is either identical or sufficiently similar to the claimed therapeutically effective amounts, and that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Examiner expressly notes that the inventor of the instant application is the named inventor of the cited reference, Penfold.
Accordingly, the limitations of claim 71 are satisfied.
Regarding claims 72, 73, and 85, Penfold ‘559 expressly teaches a pharmaceutical composition comprising triamcinolone acetonide and fludrocortisone acetate (para. [0042], [0104], [0106], Fig. 1; claim 16 and 19-21).
Regarding claim 76, Penfold ‘559 teaches that the pharmaceutically-acceptable carrier, diluent or excipient can be isotonic saline (e.g., para. [0116], [0124]-[0127], [0141], claim 13 (BSS, saline).
Regarding claim 77, Penfold ‘559 teaches that the pharmaceutically-acceptable carrier, diluent or excipient can be a vegetable oil ([para. [0116]).
Regarding claims 79 and 80, the claims are product-by-process claims. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)
The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. “[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, Penfold ‘559 explicitly teaches that the pharmaceutical compositions are suitable as injectable intravitreal compositions (paras. [0136], [0147]-[0148], [0054], [068], [0120]). The pharmaceutical compositions can be in a syringe which is construed as being a unit-dose formulation [reads on unit dose] (para. [0014], [0111]; claims 2-22 and 25). Penfold ‘559 states “dry drug powders, with a view to providing the study materials as sterile powders for reconstitution immediately prior to administration” (para. [0133]). See also paras. [0032], [0134]-[0148], claim 14, which further teach pharmaceutical compositions as powders in dose units, freeze drying, dispersing into vials [prefilling/prefilled dry power unit doses], and reconstituting [reads on reconstituting dry unit powders]. Penfold ‘559 teaches that the pharmaceutically-acceptable carrier, diluent or excipient can be isotonic saline (e.g., para. [0116], [0124]-[0127], [0141], claim 13 (BSS, saline). Accordingly, the limitations of claims 79 and 80 are satisfied.
Regarding claim 84, Penfold ‘559 teaches that the composition can include Deoxycorticosterone acetate (DA); Deoxycorticosterone (DS); or Aldosterone (e.g., abstract, paras [0035]-[0039], [0101]-[0103], claims 16-18).
Regarding claim 88, Penfold ‘559 teaches that the composition can include sodium chloride (e.g., paras [0053], [0116], table 7).
Regarding claim 89, Penfold ‘559 teaches that the composition can include polysorbate (e.g., paras [0016], [0052]-[0053], [0115]-[0117], Table 7).
Regarding claims 90, Penfold ‘559 teaches a pH 6-8 (e.g., Table 5).
Response to Arguments
Applicant traversed the rejection at pp. 9-11 of the reply filed 7/6/2026.
Applicant asserts that the cited references alone or combination do not teach or suggest "a therapeutically effective amount of fludrocortisone, fludrocortisone acetate, or fludrocortisone acetonide; and a pharmaceutically acceptable carrier, diluent, or excipient," where a therapeutically effective amount is an amount for treating geographic atrophy in a subject (Reply at p. 9). Applicant asserts the amount is specifically effective to treat/prevent dry AMD and reduce a symptom compared to baseline, such as visual acuity or other testing. Id. Applicant refers to the instant specification for the assertion that GA is an advanced form of AMD (reply at pp 9-10).
Applicant next refers to a single paragraph from each of Penfold 559 and Penfold ‘497 and alleges the entirety of the teachings of respective reference based on that single paragraph. Penfold '559 referring to para [0001]: therapeutically effective amount directed to "a pharmaceutical composition and method for making a pharmaceutical composition for treating an eye disease including a diabetic eye disease and an ocular tumour." Penfold 497 referring to para [0003]: the therapeutically effective amount is directed to "the treatment of ophthalmic conditions in the posterior region of the retina with an anti-oedematose steroid." Reply at p. 10.
Applicant asserts statistically “significant improvements in visual acuity” (reply at p. 10).
Examiner has reviewed and considered Applicants arguments, but is not persuaded.
Examiner reiterates- The cited references- Penfold ‘559 and Penfold ‘497 are by the inventor of the instant application.
Examiner reminds Applicant, patents and applications are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art.
Regarding Applicants first arguments, Applicant’s own prior work - Penfold teaches the exact same pharmaceutical compositions [comprising therapeutically effective amount fludrocortisone] and therapeutically effective amount of fludrocortisone and pharmaceutically acceptable carriers. The reference further discloses the same patient population [geographic atrophy]. See e.g., paras. [0008]-[0014], [0032], [0041], [0046], [0054], [068], [0072]-[0073], [0083]-[0084], [0111], [0120]-[0121], [0133]-[0148]; claims 5, 13-14, 20, and 25. The references teach therapeutically effective amounts, as well as methods/metrics of assessing, e.g. visual acuity or other testing. See above rejection for specifics.
Examiner further notes that evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). See M.P.E.P. § 2131.04.
The rejection is maintained for at least these reasons and those previously of record.
Pursuant to MPEP § 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP § 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP § 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
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.
Claim(s) 71-91 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Penfold (WO 2015/089559- previously cited; hereinafter referred to as “Penfold ‘559”), and further in view of Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold ‘497”).
The cited references Penfold ‘559 and Penfold ‘497 are by the inventor of the instant application. The rejection is maintained from the office action mailed 2/04/2026, but has been amended to reflect claims filed 7/06/2026.
Penfold ‘559 teaches pharmaceutical composition comprising a therapeutically effective amount of one or more compounds capable of modulating an activity of a mineralocorticoid receptor and/or a glucocorticoid receptor. The receptor modulators are preferably chosen from triamcinolone acetonide, triamcinolone, fludrocortisone or a therapeutically active analogue, derivative, homolog, pharmaceutically acceptable salt or conjugate thereof. The pharmaceutical compositions further comprise a pharmaceutically acceptable carrier, diluent or excipient (e.g., abstract, paras. [0050]-[0053], [0083], [0112]-[0117], [0124]-[0127], [0141], claims 1-6, 13, 16, 20-21, 30, 31; BSS, saline). The figures and examples disclose assessment of pharmaceutical compositions comprising fludrocortisone and saline (e.g., Fig 1, paras. [0125]-[0144]). Penfold ‘559 expressly teaches a pharmaceutical composition comprising triamcinolone acetonide and fludrocortisone acetate (para. [0042], [0104], [0106], Fig. 1; claim 16 and 19-21). Penfold ‘559 teaches a method of treating macular degeneration including [dry] age-related macular degeneration and wet age related macular degeneration comprising administration of fludrocortisone acetate (paras. [0008]-[0013], [0041], [0046], [0072]-[0073], [0083]-[0084]; claims 5, 20, and 25). Paragraph [072] states: as used herein, the term "eye disease" includes any eye disease such as, macular degeneration, maculopathy including an age related maculopathy (ARM), age related macular degeneration (AMD) including both the dry (geographic atrophy) and wet (choroidal neovascularization (CNV)), …”. The instant specification states that dry AMD comprises early AMD and geographic atrophy (GA) (paras. [0045] and [0060]). Para. [0106] and claim 21 teach a composition comprising triamcinolone acetonide and fludrocortisone acetate. Claim 25 of Penfold ‘559 recites the method, composition, use or syringe of any previous claim (e.g., claim 21) where said eye disease and/or condition is macular degeneration including age-related macular degeneration. The instant specification states that dry AMD comprises early AMD and geographic atrophy (GA) (paras. [0045] and [0060]. Penfold ‘559 states that "effective amount" refers to an amount of an agent or medicament, either in a single dose or as part of a series, which is effective for treating or preventing an eye disease or condition or predisposition thereto. This would include an amount that is effective in achieving a reduction in one or more symptom as compared to baseline prior to administration of such amount as determined, e.g., by visual acuity or other testing. The effective amount will vary depending upon the health and physical condition of the individual to be treated, the taxonomic group of individual to be treated, the formulation of the composition, the assessment of the medical situation, and other relevant factors, it is expected that the amount will fall in a relatively broad range that can be determined through routine trials (para. [0083]). Penfold teaches that the composition can be directly injected into an eye (title, paras. [0068], [0111], [0136], [0147]-[0148]).
Penfold ‘559 explicitly teaches that the pharmaceutical compositions are suitable as injectable intravitreal compositions (paras. [0136], [0147]-[0148], [0054], [068], [0120]). The pharmaceutical compositions can be in a syringe which is construed as being a unit-dose formulation [reads on unit dose] (para. [0014], [0111]; claims 2-22 and 25). Penfold ‘559 states “dry drug powders, with a view to providing the study materials as sterile powders for reconstitution immediately prior to administration” (para. [0133]). See also paras. [0032], [0134]-[0148], claim 14, which further teach pharmaceutical compositions as powders in dose units, freeze drying, dispersing into vials [prefilling/prefilled dry power unit doses], and reconstituting [reads on reconstituting dry unit powders].
Penfold ‘559 does not explicitly teach the recited fludrocortisone concentrations, or the recited additional agents.
Penfold ‘497 teaches a method of treatment of an individual with an ophthalmic condition that may comprise the step of: administering to the individual a therapeutically effective amount of a compound capable of modulating the activity of mineralocorticoid receptors within cells or tissue located in an eye or adjacent to an eye in the individual to be treated. Preferably, said compound may be an anti-oedematous steroid, more preferably a mineralocorticoid (abstract). The mineralocorticoid can be fludrocortisone, fludrocortisone acetate (e.g., para. [0149]-[0156], claims 13, 14, 19). The methods further preferably include triamcinolone acetonide (para. [0164). Penfold ‘497 teaches compositions comprising about 4 mg/ml triamcinolone acetonide (para. [0167]). Penfold ‘497 teaches that compositions can be used for treating age-related macular degeneration or senile macular degeneration (e.g., paras. [0090]-[0093], claims 1-14). Penfold ‘497 further teaches that pharmaceutical interventions with drug compounds having anti-angiogenic or angiostatic properties, such as anecortave acetate or anti-vascular endothelial growth factor (VEGF) compounds (Lucentis® (ranibizumab), Macugen®- anti-VEGF agents), for use in methods for treatment of ophthalmic conditions (paras. [0018], [0247], [0258]-[0260], [0264]). Penfold ‘497 teaches that the compositions can be administered intraocularly by injection (paras. [0199], [0203]-[0209]; claim 18).
Regarding claim 74, Penfold ‘559 teaches that the compositions can further include additional agents (e.g., paras. [0120]-[0121]. It would have been obvious to one of ordinary skill in the art to prepare a pharmaceutical composition comprising fludrocortisone acetate and a pharmaceutically acceptable carrier, diluent or excipient, as taught by Penfold, further comprising an anti-VEGF agent, as taught by Penfold ‘497. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (treatment of an ophthalmic condition such as geographic atrophy), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650. The skilled artisan would have known from Penfold that a combination of triamcinolone acetonide and fludrocortisone acetate was useful in treating geographic atrophy. Penfold ‘497 further indicated that anti-VEGF agents were useful in treating such disorders (dry AMD and geographic atrophy). The skilled artisan would have had a reasonable expectation of success in preparing a pharmaceutical composition because Penfold explicitly taught methods of preparing the compositions. The prior art clearly sets forth all substantive elements of the claimed invention and sets forth the expected outcome.
With respect to the limitation in the preamble of claim 71, “for treating geographic atrophy in a subject”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the composition. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Accordingly, claim 74 is rendered obvious.
Regarding claims 78, 81-83, and 91, the recited limitation 1 mg/ 0.1 ml is equivalent to 10 mg/mL, and 2 mg/0.1 ml is equivalent to 20 mg/ml. It would have been obvious to one or ordinary skill in the art to prepare a pharmaceutical composition comprising either 10 mg/ml or 20 mg/ml fludrocortisone. The skilled artisan would have recognized that both Penfold ‘559 and ‘497 taught pharmaceutical composition comprising fludrocortisone acetate and a pharmaceutically acceptable carrier. The skilled artisan would have recognized that Penfold ‘559 taught an effective amount was one could treat an eye disease (e.g., treating age related macular degeneration [reads on geographic atrophy]) and that a reduction in one or more symptom as compared to baseline prior to administration of such amount as determined, e.g., by visual acuity (Penfold ‘559 at eg paras. [0045], [0060], [072]; Penfold ‘497 at paras [0090]-[0094]). Penfold ‘497 explicitly taught concentrations of mineralocorticoid (fludrocortisone) administered may be about 5 mg/ml to about 10 mg/ml, about 10 mg/ml to about 15 mg/ml, about 15 mg/ml up to 30 mg/ml, about 20 mg/ml to about 50 mg/ml (para [0202]). Formulations used comprise a mineralocorticoid at a concentration from about 0.1 μg/ml to about 40 mg/ml (para [0147]). Penfold ‘497 taught that the compositions may be provided in the form of a single unit dose in (para [0201]). The optimization of a result effective parameter (e.g., dosage) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered is considered well in the competence level of an ordinary skilled artisan and pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients and excipients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements were taught by Penfold ‘559 and 497 and one skilled in the art could have combined the elements as claimed by known methods (same components and patient population) with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida V. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. V. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). It is apparent that a preponderance of evidence dictates that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Penfold.
Regarding claim 75, Penfold ‘497 teaches the anti-VEGF agent ranibizumab (brand name Lucentis®) (paras. [0018], [0246]- [0247], claim 22).
Regarding claim 86, Penfold ‘497 teaches about 4 mg/ml triamcinolone acetonide (e.g., paras [0148]- [0155], claim 17).
Regarding claim 87, Penfold ‘497 teaches that the composition can include flurbiprofen (e.g., paras [0159]-[0161], para 43., claim 17).
Further regarding claim 91, Penfold ‘559 teaches a pH 6-8 (e.g., Table 5).
Claims 71-91 are rendered obvious in view the teachings of the cited references.
Response to arguments
Applicant’s rebuttal arguments are set forth above. Examiner’s counter arguments apply to the instant 103 rejection as well and are incorporated herein in their entirety .
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 71-73, 78, 79, 81-83, 85, 86, and 91 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 6, 8, and 9 of copending Application No. 18139024 (hereinafter referred to as “the ‘024 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The rejection is maintained from the office action mailed 2/04/2026, but has been amended to reflect claims filed 7/06/2026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 71-73, claim 5 of the ‘024 application recites a method of treatment of an eye disease or condition in a subject in need thereof, the method comprising injecting into the eye a unit dose pharmaceutical composition, the unit dose pharmaceutical composition comprising 2.0 to 8.0 mg of a reconstitutable dry powder of fludrocortisone acetate and/or triamcinolone acetonide; wherein the unit dose pharmaceutical composition is comprised in a double-barrelled syringe having a first barrel and a second barrel; and wherein, for the injection, the first barrel and the second barrel are injected substantially simultaneously. Paragraph [0132] of the ‘024 application states that the eye disease includes geographic atrophy. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
Regarding claims 78, 81-83, and 91 with respect to “wherein the unit dose is 1 milligram (mg) / 0.1 milliliter (mL) or 2 mg / 0.1 mL” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features. Instant claims 71 and 78 are drawn to a pharmaceutical composition comprising fludrocortisone; fludrocortisone acetate; or fludrocortisone acetonide; and a pharmaceutically acceptable carrier, diluent, or excipient. The claimed amount of fludrocortisone; fludrocortisone acetate; or fludrocortisone acetonide or triamcinolone does not change the structure of the composition comprising fludrocortisone; fludrocortisone acetate; or fludrocortisone acetonide compounds (and triamcinolone) in the pharmaceutical composition.
Regarding claim 79, the claims of the ‘024 application recite a dry powder. Claim 79 recites a product by process limitation. Claim 6 of the ‘024 application recites that the injection comprises intravitreal and/or suprachoroidal injection. Paragraphs [206]-[0211] of the ‘024 application states the powder is reconstituted prior to intrvitreal rejection. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
Accordingly, claims 71-73, 78, 79, 81-83, 85, 86, and 91 are anticipated by the claims of the ‘024 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant did not traverse the rejection. Applicant requested that the rejection be held in abeyance (reply at p. 11).
While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
Claims 71-91 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 6, 8, and 9 of copending Application No. 18139024 (hereinafter referred to as “the ‘024 application”) in view of Penfold (WO 2015/089559- previously cited; hereinafter referred to as “Penfold ‘559”), and further in view of Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold ‘497”). The rejection is maintained from the office action mailed 2/04/2026, but has been amended to reflect claims filed 7/06/2026.
Claims 5, 6, 8, and 9 of the ‘024 application disclose a method of treatment of an eye disease or condition in a subject in need thereof, the method comprising injecting into the eye a unit dose pharmaceutical composition, the unit dose pharmaceutical composition comprising 2.0 to 8.0 mg of a reconstitutable dry powder of fludrocortisone acetate and/or triamcinolone acetonide; wherein the unit dose pharmaceutical composition is comprised in a double-barrelled syringe having a first barrel and a second barrel; and wherein, for the injection, the first barrel and the second barrel are injected substantially simultaneously. Paragraph [0132] of the ‘024 application states that the eye disease includes geographic atrophy. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
The claims of the ‘024 application do not expressly recite that the carrier is saline, or that the pharmaceutical composition further includes an anti-VEGF agent.
Penfold ‘559 teaches pharmaceutical compositions and a method for making a pharmaceutical composition comprising a therapeutically effective amount of one or more compounds capable of modulating an activity of a mineralocorticoid receptor and/or a glucocorticoid receptor, the method comprising formulating the composition to comprise one or more improved physicochemical properties. The receptor modulators are preferably chosen from triamcinolone acetonide, triamcinolone, fludrocortisone or a therapeutically active analogue, derivative, homolog, pharmaceutically acceptable salt or conjugate thereof (abstract). Penfold ‘559 teaches a method of treating macular degeneration including [dry] age-related macular degeneration and wet age related macular degeneration comprising administration of fludrocortisone acetate (paras. [0008]-[0013], [0041], [0046], [0072]-[0073], [0083]-[0084]; claims 5, 20, and 25). Paragraph [072] states: as used herein, the term "eye disease" includes any eye disease such as, macular degeneration, maculopathy including an age related maculopathy (ARM), age related macular degeneration (AMD) including dry (geographic atrophy)…”. The instant specification states that dry AMD comprises early AMD and geographic atrophy (GA) (paras. [0045] and [0060]. Para. [0106] and claim 21 expressly teach a combination triamcinolone acetonide and fludrocortisone acetate. Penfold ‘559 teaches that the pharmaceutical compositions can be suitable parenteral administration may be presented as discrete … containing a pre-determined amount of one or more therapeutic agents of the invention, as a powder (para. [0121]). Penfold ‘559 explicitly teaches that the pharmaceutical compositions are suitable as injectable intravitreal compositions (paras. [0136], [0147]-[0148], [0054], [068], [0120]). The pharmaceutical compositions can be in a syringe which is construed as being a unit-dose formulation [reads on unit dose] (para. [0014], [0111]; claims 2-22 and 25). Penfold states “dry drug powders, with a view to providing the study materials as sterile powders for reconstitution immediately prior to administration” (para. [0133]). See also paras. [0032], [0134]-[0148] which further teach pharmaceutical compositions as powders in dose units, freeze drying, dispersing into vials [unit doses], and reconstituting [reads on reconstitutable dry powders]. Thus, Penfold ‘559 expressly teaches an intention for pharmaceutical composition comprising a reconstitutable dry powder comprising fludrocortisone acetate and a pharmaceutically acceptable carrier, diluent or excipient. The pharmaceutical compositions further comprise a pharmaceutically acceptable carrier, diluent or excipient (e.g., abstract, paras. [0050]-[0053], [0083], [0112]-[0117], [0124]-[0127], [0141], claims 1-6, 13, 16, 20-21, 30, 31; BSS, saline). The figures and examples disclose assessment of pharmaceutical compositions comprising fludrocortisone and saline (e.g., Fig 1, paras. [0125]-[0144]).
Penfold ‘497 teaches a method of treatment of an individual with an ophthalmic condition that may comprise the step of: administering to the individual a therapeutically effective amount of a compound capable of modulating the activity of mineralocorticoid receptors within cells or tissue located in an eye or adjacent to an eye in the individual to be treated. Preferably, said compound may be an anti-oedematous steroid, more preferably a mineralocorticoid (abstract). The mineralocorticoid can be fludrocortisone, fludrocortisone acetate (e.g., para. [0149]-[0156], claims 13, 14, 19). The methods further preferably include triamcinolone acetonide (para. [0164). Penfold ‘497 teaches that compositions can be used for treating age-related macular degeneration (e.g., paras. [0090]-[0093]). Penfold ‘497 further teaches that pharmaceutical interventions with drug compounds having anti-angiogenic or angiostatic properties, such as anecortave acetate or anti-vascular endothelial growth factor (VEGF) compounds (Lucentis® (ranibizumab), Macugen®- anti-VEGF agents), for use in methods for treatment of ophthalmic conditions (paras. [0018], [0247], [0258]-[0260], [0264]). Penfold ‘497 teaches that the compositions can be administered intraocularly by injection (paras. [0199], [0203]-[0209]; claim 18). Penfold ‘497 further teaches saline as a pharmaceutically acceptable carrier (e.g., pars. [0193]-[0194].
It would have been obvious to one of ordinary skill in the art to prepare a pharmaceutical composition comprising fludrocortisone acetate and a pharmaceutically acceptable carrier, diluent or excipient, as taught by Penfold ‘559, further comprising saline as a carrier and including an anti-VEGF agent, as taught by Penfold ‘559 and Penfold ‘497. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (treatment of an ophthalmic condition such as geographic atrophy), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650. The skilled artisan would have known from Penfold ‘559 that a combination of triamcinolone acetonide and fludrocortisone acetate was useful in treating geographic atrophy. Penfold ‘497 further indicated that anti-VEGF agents were useful in treating such disorders (dry AMD and geographic atrophy) (instant claim 74). The skilled artisan would have had a reasonable expectation of success in preparing a pharmaceutical composition because Penfold ‘559 explicitly taught methods of preparing the compositions in a carrier, e.g., saline (instant claim 80).
Accordingly, claims 71-80 are rendered obvious.
Regarding claim 84, Penfold ‘559 teaches that the composition can include Deoxycorticosterone acetate (DA); Deoxycorticosterone (DS); or Aldosterone (e.g., abstract, paras [0035]-[0039], [0101]-[0103], claims 16-18).
Regarding claim 87, Penfold ‘497 teaches that the composition include flurbiprofen (e.g., paras [0159]-[0161],
Regarding claim 88, Penfold ‘559 teaches that the composition can include sodium chloride (e.g., paras [0053], [0116], table 7).
Regarding claim 89, Penfold ‘559 teaches that the composition can include polysorbate (e.g., paras [0016], [0052]-[0053], [0115]-[0117], Table 7).
Regarding claims 90 and 91, Penfold ‘559 teaches a pH 6-8 (e.g., Table 5).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant did not traverse the rejection. Applicant requested that the rejection be held in abeyance (reply at p. 11).
While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
Relevant Art Not Relied Upon
Ambati et al (Nat Rev Immunol. 13: 438–451 (2013)- previously cited) teach that geographic atrophy (also known as end-stage ‘dry’ age-related macular degeneration (AMD) or atrophic AMD) is characterized by confluent regions of RPE and photoreceptor degeneration as well as constriction of choroidal blood vessels [reads on absence of neovascularization] (Figs 1-2, p. 13).
Conclusion
No claims are allowed.
Claims 71-91 are pending and rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654
Prosecution Insights