Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Examiner acknowledges receipt of the reply filed 1/16/2026, in response to the final office action mailed 10/17/2025.
Claims 71-80 are newly added. Claims 51, 53-60, 62-65, and 68-70 have been cancelled.
Claims 71-80 are being examined on the merits in this office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/16/2026 has been entered.
Examiner Comment
Applicant has switched claims and inventions. The claims filed 9/29/2025 were drawn to method of treatment claims. All previously pending claims have been cancelled. The instant claims are drawn to compositions.
Examiner cautions Applicant from switching claims during prosecution.
Claim Objections- withdrawn
The objection of claim 55 is withdrawn in view of the cancellation of the claims in the amendment filed 1/16/2026.
Claim Rejections - 35 USC § 102- withdrawn
The rejection of claims 51, 53, 54, 56, 58-60, 65, and 68-70 under 35 U.S.C. 102(a)(1) as being anticipated by Penfold (WO 2015/089559- previously cited), as evidenced by Ambati et al (Nat Rev Immunol. 13: 438–451 (2013)- previously cited), is withdrawn in view of the cancellation of the claims in the amendment filed 1/16/2026.
Claim Rejections - 35 USC § 103- withdrawn
The rejection of claims 51, 53-56, 58-60, 65, and 68-70 under 35 U.S.C. 103 as being unpatentable over Penfold (WO 2015/089559- previously cited), as evidenced by Ambati et al (Nat Rev Immunol. 13: 438–451 (2013)- previously cited), and further in view of Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold 2”), is withdrawn in view of the cancellation of the claims in the amendment filed 1/16/2026.
The rejection of claims 51, 53-60, 65, and 68-70 under 35 U.S.C. 103 as being unpatentable over Penfold (WO 2015/089559- previously cited), as evidenced by Ambati et al (Nat Rev Immunol. 13: 438–451 (2013)- previously cited), and Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold 2”), as applied to claims 51, 53-56, 58-60, 65, and 68-70 are above, and further in view of Pearce et al. (Curr Opin Ophthalmol. 26: 233–239 (2015)- previously cited), is withdrawn in view of the cancellation of the claims in the amendment filed 1/16/2026.
The rejection of claims 51, 53-60, 62-65, and 68-70 under 35 U.S.C. 103 as being unpatentable over Penfold (WO 2015/089559- previously cited), as evidenced by Ambati et al (Nat Rev Immunol. 13: 438–451 (2013)- previously cited), Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold 2”), and Pearce et al. (Curr Opin Ophthalmol. 26: 233–239 (2015)- previously cited), as applied to 51, 53-60, 65, and 68-70 are above, and further in view of Teagarden et al *Freeze Drying/Lyophilization of Pharmaceutical and Biological Products, eds Rey and May, vol 206, chptr 21, pp 494-527 (2010)- previously cited), is withdrawn in view of the cancellation of the claims in the amendment filed 1/16/2026.
Response to Arguments
All previous objections and rejections are withdrawn cancellation of the claims in the amendment filed 1/16/2026.
Upon further consideration, a new ground(s) of rejection is made in view of the amendment filed 1/16/2026.
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.
Claim Objections
Claims 71, 74-77, 79, and 80 are objected to because of the following informalities:
Claim 71 should be amended to recite “comprising[[:]] a therapeutically effective amount of fludrocortisone,[[;]] fludrocortisone acetate,[[;]] or fludrocortisone acetonide; and”.
Claim 74 should be amended to recite “anti-vascular endothelial growth factor
Claim 75 should be amended to recite “consisting of[[:]] ranibizumab”.
Claim 76 should be amended to recite “carrier is
Claim 77 should be amended to recite “carrier is
Claim 79 should be amended to recite “is 1 mg mL
Claim 80 should be amended to recite “excipient is .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 78 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 78 recites the limitation "the unit dose". There is insufficient antecedent basis for this limitation in the claim.
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 and 76-80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Penfold (WO 2015/089559- previously cited). The cited reference Penfold is by the inventor of the instant application. This is a new rejection necessitated by the amendment filed 1/16/2026.
Penfold 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]).
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.
Additionally, in regards to the activity and the functionality of the composition, the MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” Since the reference teaches the same pharmaceutical composition comprising a therapeutically effective amount of fludrocortisone and a pharmaceutically acceptable carrier, diluent or excipient, the reference would have the same activities and functionalities of the instant composition.
However, it is noted that Penfold further teaches a method of treating an eye disease, e.g, macular degeneration including [dry] age-related macular degeneration comprising administration of fludrocortisone acetate (paras. [0008]-[0013], [0041]-[042], [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 the dry (geographic atrophy) …”.
Accordingly, the limitations of claims 71 and 76 are satisfied.
Regarding claims 72 and 73, Penfold 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 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 teaches that the pharmaceutically-acceptable carrier, diluent or excipient can be a vegetable oil ([para. [0116]).
Regarding claim 78, 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 “unit dose” and claimed amount of fludrocortisone; fludrocortisone acetate; or fludrocortisone acetonide does not change the structure of fludrocortisone; fludrocortisone acetate; or fludrocortisone acetonide compounds in the pharmaceutical composition.
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 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], 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 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.
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) 71-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penfold (WO 2015/089559- previously cited), and further in view of Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold 2”).
The cited references Penfold and Penfold 2 are by the inventor of the instant application. This is a new rejection necessitated by the amendment filed 1/16/2026.
Penfold 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 expressly teaches a pharmaceutical composition comprising triamcinolone acetonide and fludrocortisone acetate (para. [0042], [0104], [0106], Fig. 1; claim 16 and 19-21). Penfold teaches that the pharmaceutically-acceptable carrier, diluent or excipient can be a vegetable oil ([para. [0116]). Penfold further teaches a method of treating an eye disease, e.g, macular degeneration including [dry] age-related macular degeneration comprising administration of fludrocortisone acetate (paras. [0008]-[0013], [0041]-[042], [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 the dry (geographic atrophy) …”. Penfold 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], 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 teaches that the compositions can further include additional agents (e.g., paras. [0120]-[0121], teach the limitations of claims 74 and 75 with respect to inclusion of an anti-VEGF agent.
Penfold 2 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 2 teaches compositions comprising about 4 mg/ml triamcinolone acetonide (para. [0167]). Penfold 2 teaches that compositions can be used for treating age-related macular degeneration (e.g., paras. [0090]-[0093]). Penfold 2 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 2 teaches that the compositions can be administered intraocularly by injection (paras. [0199], [0203]-[0209]; claim 18).
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 2. "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 2 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 claim 75, Penfold 2 teaches the anti-VEGF agent ranibizumab (brand name Lucentis®) (paras. [0018], [0246]- [0247], claim 22).
Claims 71-80 are rendered obvious in view the teachings of the cited references.
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).
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, and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 71-73, claims 1 and 2 of the ‘024 application recites a medical device comprising a unit dose pharmaceutical composition, the unit dose comprising 2-8 mg of a dry powder of fludrocortisone acetate and/or triamcinolone wherein the unit dose pharmaceutical composition is comprised in a syringe for use or when used in the treatment of an eye disease or condition or predisposition thereto. Claim 5 of the ‘024 application recites a method of treatment of an eye disease or condition or a predisposition thereto in a subject in need thereof, the method including injecting into the eye a unit dose pharmaceutical composition, the unit dose pharmaceutical composition comprising 2.0 to 8.0 mg of a dry powder of fludrocortisone acetate and/or triamcinolone acetonide; wherein the unit dose pharmaceutical composition is comprised in a syringe. 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 claim 78, 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 does not change the structure of fludrocortisone; fludrocortisone acetate; or fludrocortisone acetonide compounds 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, and 79 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.
Claims 71-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18139024 (hereinafter referred to as “the ‘024 application”) in view of Penfold (WO 2015/089559- previously cited), and further in view of Penfold et al. (U.S. 2005/0245497- previously cited; hereinafter referred to as “Penfold 2”).
Claims 1-9 of the ‘024 application disclose a medical device comprising a unit dose pharmaceutical composition, the unit dose comprising 2-8 mg of a dry powder of fludrocortisone acetate and/or triamcinolone wherein the unit dose pharmaceutical composition is comprised in a syringe for use or when used in the treatment of an eye disease or condition or predisposition thereto. The claims are further drawn to a method of treatment of an eye disease or condition or a predisposition thereto in a subject in need thereof, the method including injecting into the eye a unit dose pharmaceutical composition, the unit dose pharmaceutical composition comprising 2.0 to 8.0 mg of a dry powder of fludrocortisone acetate and/or triamcinolone acetonide; wherein the unit dose pharmaceutical composition is comprised in a syringe. 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 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 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 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 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 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 2 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 2 teaches that compositions can be used for treating age-related macular degeneration (e.g., paras. [0090]-[0093]). Penfold 2 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 2 teaches that the compositions can be administered intraocularly by injection (paras. [0199], [0203]-[0209]; claim 18). Penfold 2 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, further comprising saline as a carrier and including an anti-VEGF agent, as taught by Penfold and Penfold 2. "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 2 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 in a carrier, e.g., saline. The prior art clearly sets forth all substantive elements of the claimed invention and sets forth the expected outcome.
Accordingly, claims 71-80 are rendered obvious.
This is a provisional nonstatutory double patenting rejection.
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).
Response to Arguments- as relating to new claims 71-80
Applicant asserts that the cited references do not teach or suggest the combination of treating geographic atrophy with a composition comprising fludrocortisone, fludrocortisone acetate, or fludrocortisone acetonide, as recited in the independent claims (reply filed 1/16/2026 at pp. 5-6).
Applicant asserts secondly - surprising and unexpected results with regard to treating geographic atrophy, and refers to publication filed 5/12/2020 and discussed in the amendment filed 9/11/2024, and declaration filed 8/17/2023 (reply at p. 6)- Referring to the response filed 9/11/2024- e.g. pp. 5-8, fludrocortisone acetonide (FA) is more effective than triamcinolone (TA) in the prevention of macrophage recruitment, and preserves retinal function. Figs 2-6 summarize the results of injection of fludrocortisone (limited to a single subject) of a phase 1B study - indicated there was no toxicity after 28 days (no increase in intraocular pressure and improved visual acuity). Table 1 (which applicant again mistakenly asserts was presented 5/12/2020 - was first presented as post-filing data in the declaration filed 8/17/2023) indicates that the composition does not increase intraocular pressure when used to treat geographic atrophy (reply filed 9/11/2024 at pp. 5-8).
Applicant thirdly asserts - post-filing data of 9/29/2025 indicates no increase in intraocular pressure, is a significant benefit over compositions discussed in the art, and supports nonobviousness of the present claims (reply at p. 8).
Applicant’s fourth assertion is that corresponding EPO, Japanese and of Australian patents have been granted and are generally commensurate to the instant independent claims (reply at p. 6).
Examiner has reviewed and considered applicant’s arguments but is not persuaded.
Examiner reiterates- The cited references- Penfold and Penfold 2- are by the inventor of the instant application.
Examiner reiterates- 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, and above rejection for specifics.
Examiner further notes that evidence of secondary considerations- applicant’s 2nd and 3rd arguments, 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.
Regarding Applicants fourth argument, a determination of patentability made by a foreign patent office is not binding on the USPTO. M.P.E.P. § 901.05 (III) refers to the need to obtain a “separate patent” in “each country in which patent rights are desired,” confirming the notion that U.S. patent examination is a process distinct from those of foreign patent offices. Different patent offices use vastly divergent standards of patentability, so a finding that a claim is patentable in one country is not necessarily probative of patentability in another. The examiner points out that the European Patent Office in particular is not generally considered competent to examine certain U.S. classifications, including generally those that involve enzymes and cells. See M.P.E.P. § 1801. Finally, on the international level, all written opinions of PCT applications are nonbinding and a patent does not issue; what does issue is an international preliminary examination report (IPER), which is nonbinding on the Elected States. See M.P.E.P. § 1878.01, Item V. Findings of foreign patent offices do not obviate applicant’s burden to comply with the relevant patent statutes of the United States.
Conclusion
No claims are allowed.
Claims 71-80 are pending and rejected.
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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654