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 .
Election/Restrictions
Applicant’s election without traverse of methods of treating myotonic muscular dystrophy in the reply filed on 10 July 2025 is acknowledged.
Applicant asserts at page 5 of the response that claims 1, 4, 6-14 and 22-23 encompass the elected species and that claims 16-21 and 24 are directed to non-elected species and withdrawn. Applicant’s characterization of which claims do not read on the elected species appears to be in error. Claim 17 is generically directed to treating “a muscular dystrophy”, therefore, it does encompass the elected species. Claim 21 recites that the muscular dystrophy is one of 8 types which includes myotonic muscular dystrophy, therefore, it does encompass the elected species as well.
Claims 16, 18-20 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 July 2025.
Drawings
The drawings are objected to because they do not comply with 37 CFR 1.84(a)(1):
(a) Drawings. There are two acceptable categories for presenting drawings in utility and design patent applications.
(1) Black ink. Black and white drawings are normally required. India ink, or its equivalent that secures solid black lines, must be used for drawings.
Specifically, Figures 1A-1B - the figure legends are not solid black and therefore, fuzzy;
Figure 2A-2B - the figure legends are not solid black and therefore, fuzzy;
Figure 3A – lines are not solid;
Figures 3B-3C and 4A-4B – legends on the axis are not solid black, and therefore fuzzy and the lines are not solid black;
Figure 5A– bars are not in black/white, cannot make out error bars as they are not solid black, lines are not solid black. Additionally, as there is only one figure for 5, it should not be labeled “A” as there is only one panel;
Figure 6A (only one panel, should not have “A”) - lines are not solid, Y-axis is blurry because not solid lines;
Figure 7A-7B – labels on the axis are not solid lines, therefore blurry;
Figure 8A-8B – error bars are not solid lines, therefore faint and fuzzy;
Figure 9B-9G – text is not solid black ink, therefore, fuzzy;
Figure 10B-10E – text is not solid black ink, therefore, fuzzy;
Figure 11A – the syringe illustration is too faint (not black and white) and will not reproduce clearly;
Figure 11B-11F – text is not solid black ink, therefore, fuzzy;
Figure 16A-16B and 17A-17B – the labeling of the axis is not solid black lines and therefore fuzzy (as are the lines in the drawings);
Figure 18A-18B – not in black/white (gray scale reproduces as dotted lines and therefore, fuzzy);
Figure 19 – not in black/white (lines and labels) and the labels are so small, they cannot be read;
Figure 20 – the square symbol is not in black/white and therefore fuzzy and not reproducible and the lines and labels are fuzzy because they are not solid black lines;
Figure 21A-D – gray scale results in fuzzy lines, not solid black as required;
Figure 21F – the error bar on the “vehicle” is not solid black and will not reproduce clearly;
Figure 22A-22E – error bars are not solid black, the box in 22A is gray; the treatment line in 22E is not compliant nor is the label of this line (and figure legend lines are blurry);
The labeling on page 27 (labeled as Figure 22B) is incorrect. The labeling should be Figure 23B. Also, the error bars are not solid black and lines are not solid;
Figure 24D – error bars are not solid black.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specifically, Figures 13A-B, 14, 15A-15B, 19, 22A-22E, 23A-23B, and 24A-D all recite “6XHis”. This is an amino acid sequence which requires a sequence identifier. In order to correct this, the sequence identifier can either be included in the drawing itself or it can be put in the Brief Description of the Drawings.
Paragraphs [0043], [0044], [0046], [0055]-[0058], [00142], [00204]-[00208], [00210]-[00212] all recite 6xHIS, which requires a sequence identifier.
Paragraphs [0091] and [0096] contain sequences with no identifiers.
Paragraph [00190] at page 48, the recitation of HSA-IGF2R6 (Seq. ID 81) and IGF2 (Seq. ID 76) appears to be an error. The sequence listing for the instant application only has 60 Sequence identifiers. Therefore, reference to Seq. ID 81 and Seq. ID 76 is nonsensical. Further, it is not clear what “IGF2R6” means; this may be a typographical error.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The claims are limited to methods of treatment and the polypeptide being utilized is limited to a fusion protein of IGF2 with a mutation of R61A. The invention is not directed to heparin-associated polypeptides and uses thereof.
The disclosure is objected to because of the following informalities:
The specification at [0063] states that “or” is meant to include “and/or”. This is repugnant to the meaning of “or” which is a conjunction and is used to link alternatives. “And” is a conjunction used to connect items that are to be taken jointly. “Or” cannot mean both “and” and “or” as they are terms with different meanings.
Paragraph [0083] mentions “The Table of Sequences” but there is no such table provided in this passage. This is confusing as it is unclear where this Table would be located. If the Table were numbered, it may make more sense or if direction to the table (such as “at the end of the specification) were provided, it would be less confusing.
The specification at page 33 has two tables which are labeled as FIG 1A and FIG 1B in the body of the specification. This is improper. If they are Figures, they need to be included in the drawings. If they are Tables, they should be identified as such and not referred to as Figures. If the reference to Figure 1A and 1B is meant that the results of Examples 2 and 3 are found in these figures, then the paragraphs should be modified to reflect this. As currently presented, it appears that the tables are being called Figure 1A and Fig 1B.
The specification at page 34 has three tables which are labeled as FIG 2A, 2B and 2C in the body of the specification. Again, this is improper for the reasons stated above with regard to page 33 of the specification. This continues throughout the specification in the Examples. If this portion of the specification is describing the information contained in the Figures, this information should be in the Brief Description of the Drawings. If this disclosure is merely describing the results of the preceding experiments, then it would be more clear to use descriptive language such as “Results are shown in Figures 3A-3B”, “Figure 3B is a bar graph of …”, etc. As the specification is currently drafted, it is very confusing. Additionally, the Tables should be numbered.
The Tables found at pages 36-40 and 43 of the specification are not compliant with 37 CFR 1.52 as the text and the lines are not solid black.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim references “HSA-IGF2R61A” which is an abbreviation with no explanation as to the meaning of the terms. While Applicant may wish to refer to a construct by shorthand terminology, that short-hand terminology should be spelled out at the first instance of its use. Appropriate correction is required.
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, 4, 6-14, 17, 21-23 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 is directed to a method of treating a muscle wasting condition which administers a fusion protein of human serum albumin and IGF2 which contains a mutation of alanine for arginine at position 61. While the instant specification provides evidence that the IGF2 mutant fusion protein stimulates proliferation and differentiation of myoblasts, not all muscle wasting conditions would be expected to be treated by administration of the fusion protein recited in claim 1. There are a number of metabolic diseases of the muscle which result muscle wasting for which merely increasing the amount of muscle would not be effective in treating the condition. For instance, hypokalemic and hyperkalemic periodic paralysis is considered a muscle wasting condition which is caused by genetic mutations affecting muscle ion channels. Increasing muscle mass would not be therapeutic because the muscle which is generated would still have defective ion channels. There numerous genetic conditions, such as myotubular myopathy, which result in defective proteins in the muscle which impair proper muscle development and function for which increasing the amount of muscle in the subject would not be considered therapeutic as the muscle would still be impaired and not function properly. The instant claims are not enabled for treating all muscle wasting conditions because not all conditions would be treated by increasing the amount of muscle if the muscle which is generated is not functioning properly.
The instant specification teaches that IGF2 and HSA-IGF2R61A can promote differentiation of human myoblast cells (Examples 3-4). Example 6 of the specification demonstrates that sodium butyrate enhances muscle fusion (fusion of myoblasts) as well as enhancing IGF2 activity (Examples 7-8) in cultured myoblasts. Examples 9 and 11-12 demonstrated that IGF2 enhances gene expression in human myoblast cells.
Example 25 is prophetic. Example 26 administered IGF2 fusion polypeptide (no disclosure of which fusion was administered) with sodium butyrate to mdx mice which resulted in increased grip and forelimb strength, increased muscle weight and increased endurance. The example does not administer the IGF2 fusion in the absence of sodium butyrate.
None of the examples in the instant specification are directly related to myotonic muscular dystrophy type I. Generally, myotonic muscular dystrophy is caused by a mutation in the DMPK gene on chromosome 19 (type I) or a mutation in the CNBP gene on chromosome 3 (type II). DMPK codes for myotonic dystrophy protein kinase, which is expressed in skeletal muscle. In DM2, expression of CNBP is reduced, which causes muscle toxicity. Mutations of DM1 and DM2 cause sequestering of RNA-binding proteins which causes dysregulated RNA splicing. This dysregulated RNA splicing is toxic to skeletal, cardiac and smooth muscle. Mutated DMPK RNA in DM1 can cause a loss of chloride channel function and result in myotonia. None of the examples presented in the instant specification appear to be predictive of biological effects in subjects with myotonic muscular dystrophy type I. While IGF2 would be expected to increase proliferation of myoblasts or increase fusion of myoblasts to form muscle fibers, the genetic mutations which are present in the subjects with myotonic muscular dystrophy type 1 would impair the muscle which is formed. Therefore, while there would be more muscle present, the muscle would not function normally and therefore, it would not be predictive that a therapeutic effect would be realized and the claims are not enabled for treating myotonic muscular dystrophy type 1.
The claims would be enabled for a method of increasing the proliferation of myoblasts or increasing fusion of myoblasts to form muscle fibers in a subject in need thereof.
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.
Claims 1 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “an HSA-IGF2R61A”. However, “an” is an indefinite article and it is not readily apparent what “HSA-IGF2R61A” encompasses. The instant specification provides no definitive definition for “HSA-IGF2R61A”. It is assumed that “HSA-IGF2R61A” is a fusion protein of human serum albumin with IGF2, wherein the IGF2 has a substitution of alanine for arginine at position 61. However, IGF2 does not have an arginine at position 61, so it is not clear what R61A means in the context of IGF2 as there is no antecedent basis for the mutation without reference to an amino acid sequence. While it is acknowledged that such a construct may include fusions with or without linkers and that the IGF2 component of the fusion may come from different mammalian species, the use of “an” is still indefinite as the intended variation and the intended genus of molecules to be included within the term of “HSA-IGF2R61A” is unclear as the metes and bounds of “an HSA-IGF2R61A” are not known.
Claim 4 is indefinite for the recitation of “an R61A mutation within an IGF2 C-domain”. First, there is a lack of antecedent basis for the position which is referenced for the stated mutation. Second, the C-domain of IGF2 is found at amino acid positions 29-40 in the human IGF2 amino acid sequence (see Figure 6 of Baral et al. (2019) PLoS ONE 14(6): e0219155). Within this C-domain, there are 5 arginine residues and without a reference sequence, it is unclear which “R” is intended as none of them correspond to amino acid position 61.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites “further comprising the step of increasing a regenerative capability of a myoblast in the subject”. This limitation is not further limiting because the compound being administered possesses this property and therefore, the regenerative capability of the myoblasts would have been increased when the compound was administered.
Claim 7 recites “wherein the regenerative capability is a proliferation, a degree of differentiation or a cellular survival”. This limitation is not further limiting because the compound being administered already possesses these properties.
Claim 8 recites “wherein increasing a proliferation of the myoblast produces an increase in new myofibers”. This limitation is not further limiting because this is the process that occurs when the compound of claim 1 is administered. Merely stating the outcome of administration of the compound is not a further limitation of the method and the claim from which claim 8 depends.
Claim 9 recites “wherein the subject has an increase in a muscle regeneration”. This limitation is not further limiting because this is the process that occurs when the compound of claim 1 is administered. Merely stating the outcome of administration of the compound is not a further limitation of the method and the claim from which claim 9 depends.
Claims 10-14 are not further limiting of the claim from which they depend (claim 7) as all the recited outcomes would be inherent to the administration of the HSA-IFG2R61A compound. A recitation of the outcome of administration of the HSA-IFG2R61A compound is not a further limitation of the claimed method. If the recited outcome is dependent on a particular amount/dosage to be administered, then the claims could be written as such. However, in view of the disclosure in the instant specification, the various outcomes which are recited cannot be independently achieved in the absence of any one of the other outcomes which are recited.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 6-1417, 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,329,801. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘801 are directed to the same fusion protein used in the instantly claimed methods and a pharmaceutical composition thereof. While the claims of ‘801 do not recite methods of use, the disclosure of ‘801 clearly intends use of the HSA-IGF2R61A fusion protein for treating a muscle wasting conditions and muscular dystrophies (see column 5, lines 20-21; column 14 beginning at line 51 to column 15, line 32). ‘801 specifically discloses treating myotonic muscular dystrophy (column 15, lines 30-32) with the pharmaceutical composition of the claims. Therefore, administration of the pharmaceutical composition of ‘801 to treat myotonic muscular dystrophy would be obvious over the claims of ‘801.
The instant application does not claim priority to U.S. Pat. No. 12,329,801. Therefore, the prohibition of double patenting for divisional applications does not apply (see 35 U.S.C. 121). The court in Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company (611 F.3d 1381 (2010)) found claims in a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The court held that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The court stated
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, … and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
Pfizer, 518 F.3d at 1363 n.8 (emphases added): Geneva, 349 F.3d at 1386 (quoting In re Byck, 18 C.C.P.A. 1208, 48 F.2d 665, 666 (CCPA 1931)). The court also pointed out that a “person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1374 (Fed. Cir. 2009)(emphasis added): Aquatex Indus., Inc. v. Techniche Solutions, 419 F.3d 1374, 1380 (Fed.Cir.2005); Phillips, 415 F.3d at 1313.
Therefore, the instant claims are obvious over the patented claims of ‘801 which claims the IGF2 fusion protein of the instantly claimed methods and discloses the intended use of the IGF2 fusion protein in the claimed methods.
Conclusion
No claim is allowed.
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.
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/Christine J Saoud/Primary Examiner, Art Unit 1645