DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment filed 09 April 2026 has been received and entered. Claims 1-2 and 20 have been amended, claim 24 has been newly added and claims 3, 21 and 23 have been canceled. Claims 1-2, 4-20, 22 and 24 are currently pending and under consideration in the instant Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant's response and withdrawn.
Applicant’s arguments filed 09 April 2026 have been fully considered but are not found to be persuasive.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09 April 2026 has been considered by the examiner.
Drawings
The drawings are objected to because they do not comply with 37 CFR 1.84(b)(1).
(b) Photographs.—
(1) Black and white. Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. For example, photographs or photomicrographs of: electrophoresis gels, blots (e.g., immunological, western, Southern, and northern), autoradiographs, cell cultures (stained and unstained), histological tissue cross sections (stained and unstained), animals, plants, in vivo imaging, thin layer chromatography plates, crystalline structures, and, in a design patent application, ornamental effects, are acceptable. If the subject matter of the application admits of illustration by a drawing, the examiner may require a drawing in place of the photograph. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent.
Figure 5 is not compliant with 37 CFR 1.84 (b)(1). No details are visible as all of the squares look the same.
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Specification
The abstract of the disclosure is objected to because it is not directed to that which the invention pertains. The “invention” is defined by the claims and the claims are not directed to compositions for use in treating ocular conditions. The only compositions which are provided for the invention to which the instant application pertains are IGF-1 molecules and the claims no longer recite 90% sequence identity. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
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 1-2, 4-20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating dry eye disorder or Meibomian gland dysfunction by administration of an IGF-1 variant comprising an arginine at position 3, does not reasonably provide enablement for a method of treating an ocular condition as broadly claimed with an IGF-1 variant as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.''
The claims are directed to methods of treatment which require the administration of an “IGF-1 variant” which comprises an arginine at position 3 and has at least 95% sequence identity to IGF-1 (SEQ ID NO:1). However, none of the claims require that the IGF-1 variant possess any particular biological activity such as being an agonist or an antagonist. The claims merely require that the IGF-1 variant have some degree of amino acid sequence identity to SEQ ID NO:1 and have a substitution at position 3 or have reduced affinity for an IGFBP (claim 2). The instant claims are not enabled for IGF-1 variants which are not agonists of the IGF-1 receptor. The claimed method requires activation of the IGF-1 receptor yet the claims are directed to IGF-1 variants in general and there is no requirement that they possess any particular functional activity. Therefore, the claims are not enabled for their full scope of IGF-1 variants encompassed by the claims.
The claims are also directed to methods of “treating an ocular condition”. However, the instant specification is not enabled for treating any and all ocular conditions by the administration of an IGF-1 variant which comprises an arginine at position 3. The entire specification is directed to methods of treating dry eye disorder or Meibomian gland dysfunction and there is no disclosure of what other types of “ocular condition” may be treated by increasing lipid content within a Meibomian gland or increasing lipid release from the Meibomian gland. A review of the prior art does not support the use of IGF-1 for the treatment of ocular conditions in general. The majority of the prior art suggests that IGF-1 antagonists are used for treating various ocular conditions such as thyroid eye disease and diabetic retinopathy and that administration of IGF-1 agonists is unpredictable and does not necessarily result in the treatment of any particular ocular condition.
Stuard et al. (2020, Front. Endocrinol. 11:24. Doi: 10.3389/fendo.2020.00024) teach that IGF-1 plays a role in proliferation, differentiation and migration of cells in the eye which are essential for vision. In an experimental environment, IGF-1, in combination with other factors such as Substance P, can promote wound healing in the cornea (see Table 1 at page 7). However, IGF-1 also stimulates fibrosis during wound healing (see page 9, column 2, top) and fibrosis is a leading cause of blindness in the cornea. Stuard et al. states that there is a growing body of evidence to indicate that IGF family members play an important role in fibrosis (see page 12, column 2, top). Therefore, while IGF-1 may be a tempting molecule for use in wound healing in the eye, the use of such would be considered unpredictable because IGF-1 also promotes fibrosis which can lead to blindness.
IGF-1 has also been implicated in the initiation and progression of diabetic retinopathy and diabetic macular edema. Malepati et al. (Int. J. Mol. Sci. 2025, 26, 3961. https://doi.org/10.3390/ ijms26093961) teach that IGF-1 has proangiogenic effects and contributes to the development of aberrant vessels within the retina in diabetic retinopathy (see page 3, first paragraph; Figure 1 at page 4). Malepati et al. also teach that IGF-1 impacts the inflammatory processes in diabetic retinopathy and diabetic macular edema where excesses and deficiencies both lead to vision loss. Malepati et al. state that IGF-1 likely impacts retinal inflammation in a context-dependent manner and “the fine-tuning of IGF-1 expression is necessary to prevent the progression of DR and DME” (see page 7, top of page and Figure 3). Because of its role in DM and DME, inhibition of IGF-1 is a therapeutic treatment for DM and DME (see page 9).
Truong et al. (Ophthalmic Plast. Reconstr. Surg. 39(1): 4-12, 2023) provides a review of publications which involved IGF-I and the eye wherein the publications discussed IGF-1 in the human eye from January 2011 to August 2021. Truong et al. provides Figure 4 which lists the known ocular system effects of the IGF-1/IGF1R pathway and provides a description of use of IGF-1 and/or inhibitors for treatment in the publications which were reviewed. At page 8, Truong et al. discusses IGF-1 involvement with retinal function and angiogenesis and concludes that the literature is confusing with regard to a role for IGF-1 therapy in mitigating retinopathy of prematurity and retinal wound healing. Truong et al. found that IGF-1 therapy may be useful under certain conditions but harmful in others (see page 8, column 2, paragraph 2). Truong et al. indicates that while IGF-1 has been found to be important for ocular development, activation of the receptor for IGF-1 has been associated with cancer (see page 9, column 1, paragraphs 3-5). Likewise, while the art may suggest that IGF-1 therapy may benefit patients with acute or chronic uveitis, IGF-1 was also associated with increased inflammatory response which could worsen the condition and Truong et al. suggest that further studies are needed (see page 9, column 2, paragraph 3). Truong et al. concludes by indicating that while there may be a role for IGF-1 in treatment of eye conditions, the outcomes are clearly unpredictable and that the art is “just beginning to understand the complex interactions of these biologic molecules and their potential therapeutic applications”. Therefore, the state of the prior art with regard to treating ocular conditions with IGF-1 is, at best, experimental.
In view of the breadth of the claims with regard to “ocular condition” and IGF-1 variants, the lack of the predictability of the art to which the invention pertains with regard to IGF-1 effects in the eye, complete absence of ocular conditions to be treated beyond dry eye and Meibomian gland dysfunction, lack of working examples beyond dry eye and Meibomian gland dysfunction, undue experimentation would be required to practice the method as currently claimed and therefore, the claims are not enabled for their full scope.
Response to Arguments
Applicant asserts at page 9 of the response that claim 1 has been amended to recite that the IGF-1 variant has agonist activity. Applicant’s amendment is noted, and while obviating the issue with regard to the nature of the variant (agonist/antagonist), the claim has also been amended to recite “ocular condition” which necessitated the new ground of rejection above.
Claims 1-22 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.
Claim 1 is directed to a method of treating an ocular condition by administration of an IGF-1 variant comprising an arginine at position 3 and having at least 95% sequence identity to SEQ ID NO:1 wherein the administration results in an increase of lipid content of the Meibomian glands of the subject. Claim 2 recites that the IGF-1 variant has reduced affinity to at least one IGF binding protein relative to wild-type IGF-1 to the IGFBP. Claims 8-17 require particular physiological outcomes from the administration of the IGF-1 variant.
The instant specification discloses IGF-1 having the amino acid sequence of SEQ ID NO:1 and 4 other IGF-1 molecules:
IGF-1 Ea (SEQ ID NO:7) which is an IGF-1 precursor (with C-terminal extension compared to SEQ ID NO:1).
IGF-1 Des 1-3 R37X (SEQ ID NO:6) which is IGF-1 with a deletion of amino acids at positions 1-3 and 37 relative to SEQ ID NO:1.
IGF-1 Des 1-3 (SEQ ID NO:8) which is IGF-1 with a deletion of amino acids at positions 1-3 relative to SEQ ID NO:1.
IGF-1 E3R (SEQ ID NO:4) which is IGF-1 with a substitution of arginine at position 3 relative to SEQ ID NO:1.
Therefore, the only “variants” of IGF-1 which are disclosed are IGF-1 with the deletion of the amino acids at positions 1-3, IGF-1 with the deletion of positions 1-3 in combination with a substitution at position 37 and IGF-1 with the substitution of position 3 with arginine. These are the only “IGF-1 variants” for which the instant specification provides an adequate written description. The specification fails to provide an adequate written description of the full scope of IGF-1 variants encompassed by the instant claims.
As pointed out above, the specification discloses only 3 variations from the native IGF-1 amino acid sequence of SEQ ID NO:1 (deletion of amino acids 1-3, substitution of position 3 and deletion of position 37 in conjunction with the 1-3 deletion). These variants have written description. However, the claims encompass variants with up to 5% variation as well as no guidance or direction as to which alterations could be made and still result in an IGF-1 molecule which would have the necessary functionality to be useful in the claimed method. Claim 2 requires that the IGF-1 variant have reduced affinity for IGFBP but the instant specification fails to provide an adequate written description of what alterations could be or should be made to IGF-1 to achieve this effect outside of the known modification in the prior art of deleting the first 3 amino acids or substituting position 3 of IGF-1 (see Dubaquie et al. Biochemistry 38: 6386-6396, 1999 and Ballard et al. Int. J. Biochem. Cell Biol. 28: 1085-1087, 1996).
The instant specification fails to provide an adequate written description which encompasses the breadth of the current claims in that only 3 variants of IGF-1 have been provided and the specification lacks guidance as to what positions may be modified and be tolerant to modification and still result in a protein that has the required functionality necessary to practice the method of the claims. Outside of the 3 variations which are disclosed and which were already known in the prior art before the effective filing date of the claimed invention, there is no disclosure of structure/function relationships from which a person of ordinary skill in the art would be able to make reasonable assumptions as to any other amino acid positions or substitutions which possibly might result in an IGF-1 variant with the necessary functionality required by the claims.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, while the specification teaches 3 IGF-1 variants, the specification does not provide sufficient description for the full breadth of the claims with regard to any other modifications or variability which would result in the functionality necessary for the claimed method. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the encompassed variants with substitutions, deletions and/or additions with the resultant growth factor variants having the requisite activity required for the claimed method and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 (BPAI 1993). In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. In Fiddes, the specification provided only the bovine sequence.
Therefore, the claims do not meet the written description provision of 35 U.S.C. §112, first paragraph as the specification does not provide an adequate written description of the encompassed genus of IGF-1 variants of the instant claims. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Response to Arguments
Applicant asserts at page 10 that the claims have been amended to recite 95% identity which narrows the scope of the claim to effectively only allowing for two substitutions relative to SEQ ID NO:1. Applicant’s argument has been fully considered, but is not found persuasive.
While the claim has been amended to reduce the amount of variability permitted in the variant of the claim, the specification still fails to provide any guidance as to what modifications can be made, beyond the 3 disclosed IGF-1 variants which are exemplified, and still result in an IGF-1 molecule that has the necessary functionality required by the claimed method. The scope of the variants which are encompassed by 95% amino acid sequence identity is broader than two substitutions as percent identity also includes insertions and deletions as well as substitutions. The instant specification does not identify any other positions which may be modified without impairing the ability of the IGF-1 variant to function in a manner such that it could be used in the claimed method. The specification does not provide any examples or disclosure regarding such, the specification does not point to any prior art teachings which inform the skilled artisan regarding such and due to the nature of the claimed invention, it would require undue experimentation to determine which variants which meet the structural requirements of the claims would also possess the necessary functionality required by the claims.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 5-20, 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US Pat. Pub. 2015/0141328 A1) in view of Flint et al. (J. Endocrinol. 140(2): 211-216, 1994) and Dubaquie‘ (Biochemistry 38: 6386-6396, 1999).
Sullivan et al. teach methods of stimulating human meibomian gland epithelial cell function by the administration of IGF-1 or an IGF-1 analogue (see [0011]). Sullivan et al. also teach that the IGF-1 can be administered as a pharmaceutical and that the pharmaceutical composition can include additional elements such as an ophthalmic demulcent, an excipient, an astringent, a vasoconstrictor and/or an emollient (see [0014]) and the IGF-1 which was administered in the experiments dissolved in phosphate-buffered saline. Sullivan et al. teach that the method provides a therapeutically effective amount of IGF-1 or an IGF-1 analogue topically to the ocular surface or immediate vicinity of an eye of a patient showing signs or symptoms of meibomian gland dysfunction, evaporative dry eye, lipid abnormality of meibum or the tear film and/or Sjögren’s syndrome (see [0016]). Therefore, Sullivan et al. teach a method of treating dry eye disorder or Meibomian gland dysfunction, which are ocular disorders, in a subject in need thereof by locally administering to an eye or eyelid a pharmaceutical composition comprising a therapeutically effective amount of an IGF-1 variant having at least 95% sequence identity to IGF-1 (SEQ ID NO:1) wherein the local administration of the pharmaceutical composition results in an increase of lipid content of the Meibomian glands of the subject (see [0103] and [0121]).
Claims 18-19 recite that the method does not comprise administration of any additional phopholipidosis-inducing agents or azithromycin or doxycycline. However, Sullivan et al. teaches that IGF-1 acts on human meibomian gland epithelial cells and stimulates proliferation, increases SREBP-1 expression and promotes lipid accumulation in these cells in the absence of any additional phopholipidosis-inducing agents or azithromycin or doxycycline. Sullivan et al. provides an analysis of why phopholipidosis-inducing agents and azithromycin or doxycycline are used in method of treating dry eye and meibomian gland dysfunction, but Sullivan et al. also provides for the use of IGF-1 alone (see [0002]).
Sullivan et al. does not specifically disclose that the pharmaceutical composition is administered via an eyedropper (see claim 5). However, Sullivan et al. clearly teach topical administration to the ocular surface of a subject or to an area immediately adjacent thereto (see claim 1 of Sullivan et al.). One of ordinary skill in the art would readily interpret this administration as encompassing using an eyedropper as this is the routine method of administering topical compositions to the ocular surface. Sullivan et al. also does not specifically disclose that the pharmaceutical composition is a “cream” (see claim 7). However, Sullivan et al. does teach acceptable excipients for the pharmaceutical compositions which include an emollient and emollients are commonly contained in eye gels and creams. Therefore, one of ordinary skill in the art would readily envision that a pharmaceutical composition which included an emollient as being a composition in the form of a gel or cream.
Sullivan et al. does not teach an IGF-1 variant which has a substitution at position 3 with arginine, relative to the wild-type amino acid sequence of SEQ ID NO:1.
Flint et al. teach an IGF-I variant which has a single amino acid substitution at position 2 which has reduced binding affinity to insulin-like binding protein (see abstract).
Dubaquie’ et al. teach that substitution of amino acid position 3 of IGF-1 results in an IGF-1 molecule with reduced binding affinity for IGF binding proteins. IGF-1 molecules which have substitutions at position 3 not only have reduced binding affinity for IGFBP1 and IGFBP3, but additionally IGF-1 molecules with reduced affinity for IGFBPs also have increased mitogenic potency due to the reduction in IGFBP binding (see page 6392, column 2, last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the IGF-I variant of Flint et al., which has a substitution of arginine at position 3, for the IGF-I molecule of Sullivan because Dubaquie’ et al. teach that substitutions at position 3 reduce the binding affinity of the IGF-I molecule for IGF binding proteins which increases the mitogenic potency of the IGF-I variant. Claims 8-17 require particular physiological results to be obtained from the administration of the IGF-1 pharmaceutical composition to the subject. While the prior art of Sullivan did not measure/assess all of the outcomes recited in claims 8-17, Sullivan et al. does clearly disclose treating the eye in patients in need thereof with IGF-I and therefore, one would reasonably expect the same outcomes from the administration of the IGF-I variant of Flint et al. One would reasonably expect the same outcomes because the outcomes which are recited are dependent on the actions of IGF-I and not any newly gained functionality of the IGF-I variant of the claims.
Claim(s) 1-2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US Pat. Pub. 2015/0141328 A1) in view of Flint et al. (J. Endocrinol. 140(2): 211-216, 1994), Dubaquie‘ (Biochemistry 38: 6386-6396, 1999) and WO 2015/169944 A1 (Speri et al.).
The disclosures of Sullivan et al., Flint et al. and Dubaquie’ et al. are provided above. None of the cited references specifically state that the local administration is performed daily.
WO 2015/169944 A1 teaches pharmaceutical compositions for the treatment of ocular diseases, including dry eye. ‘944 teaches that the frequency of administration of eye drop formulation is once daily or in the range from about one to about eight times a day (see claim 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to practice the method of Sullivan et al. with the IGF-1 variant of Flint et al. and to topically administer the pharmaceutical composition comprising the IGF-I variant on a daily basis. Eye treatments a typically administered as eye drops or as creams and require multiple applications, which are typically daily or multiple times daily as taught by ‘944. Therefore, practicing the method of Sullivan et al. with the IGF-I variant of Flint et al. with administration daily as taught in ‘944 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
Applicant argues at pages 12-14 that none of the art rejections teach each and every element of claim 1 because none of the references taught an IGF-I variant with an arginine at position 3. Applicant’s arguments have been fully considered but are not found persuasive. As the claims have been amended to specifically recite an IGF-I variant with an arginine at position 3, the claims have now been rejected by a combination of references, including Flint et al. which teaches an IGF-I variant with an arginine at position 3.
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 1-2, 4-20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/300,509 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass treating the same conditions with the same compound. The claims of ‘509 are limited to an IGF-1 variant comprising the amino acid sequence of SEQ ID NO:17. The IGF-1 molecule of the claims of ‘509 has the same amino acid sequence as that of IGF-1 with a substitution at positions 3 and 49. The substitution at position 3 reduces the affinity of IGF-1 for IGFBP, therefore, this molecule meets the limitations of instant claims 21-2. Additionally, this molecule has at least 97% sequence identity to SEQ ID NO:1, therefore, this molecule meets the limitations of the instant claims 1 and 22. ‘509 also claims pharmaceutical compositions which have the same composition as those administered in the instant claims as well as pharmaceutical forms to be administered and administration routes. Lastly, ‘509 details the therapeutic effects which would be achieved by administration of the pharmaceutical composition (claim 3) which are the same effects to be achieved by the claimed method (see claims 8-17). Lastly, ‘509 claims a method of treatment and methods of treating ocular conditions, dry eye disease or Meibomian gland dysfunction would be obvious over the limitations in claims 12-13 which state that the purpose of the kit is for treating these conditions, which are the same conditions being treated in the instant application. Therefore, the instant claims are not patentably distinct from those of ‘509.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues at page 14 of the response that the instant application has an earlier patent term filing date and is otherwise in condition for allowance, therefore the rejection should be withdrawn. Applicant’s argument has been fully considered, but is not found persuasive. The instant application is not allowable and therefore, the rejection is maintained for the reasons of record.
Claims 1-2, 4-20, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 107-129 of copending Application No. 19/242,613 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass treating the same conditions with the same compound. Claims 107-127 of ‘613 are directed to pharmaceutical compositions formulated for local administration to an eye comprising an IGF-1 variant. The IGF-1 molecule of the claims of ‘613 corresponds to the instant claims (see claims 107-110 and 126-127 compared to claims 1-2 and 22 of the instant application). While claim 1 of the instant application limits the amino acid substitution at position 3 to arginine and the claims of ‘613 recites a substitution at position 3, one of ordinary skill in the art would read the claims in light of the specification and position 3 is mutated to arginine and therefore, this would be an obvious substitution as this substitution is taught to result in reduced affinity as required by claim 107 of ‘613. ‘613 also claims pharmaceutical compositions which have the same composition as those administered in the instant claims (see claims 111-112 and 118 compared to claims 5-7 and 20 of the instant application) as well as pharmaceutical forms to be administered and administration routes. Lastly, ‘613 details the therapeutic effects which would be achieved by administration of the pharmaceutical composition (see claims 113-116, 119-125) which are the same effects to be achieved by the claimed method (see claims 8-17). Lastly, ‘613 claims the same method as the instant application and use of any of the claimed pharmaceutical compositions of ‘613 in the method of claim 129 would be obvious. Therefore, the instant claims are not patentably distinct from those of ‘613.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues at page 15 of the response that the pending claims are patentably distinct from the claims of ‘613 because the claims of ‘613 do not relate to use for an IGF-1 variant for the treatment of an ocular condition. Applicant’s argument has been fully considered, but is not found persuasive. ‘613 claims a method of treating dry eye disorder or Meibomian gland dysfunction in claim 129 which is clearly a method of treating an ocular disorder. The rejection was made under obviousness and the claimed methods would be obvious over the claims of ‘613 which are directed to pharmaceutical compositions which are the same as those utilized in the claimed method. ‘613 details the therapeutic effects which would be achieved by administration of the pharmaceutical composition (see claims 113-116, 119-125) which are the same effects to be achieved by the claimed method (see claims 8-17). Lastly, ‘613 claims a method which anticipates the method of claim 1 and which achieves the same results as claims 8-14 as the instant application and use of any of the claimed pharmaceutical compositions of ‘613 in the method of claim 129 would be obvious.
Conclusion
No claim is allowed.
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 Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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