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 .
Claim Status
Claims 1-6, 8-10, 12-13, 15-16, 19-23, 28, 30 and 43 are currently pending.
Election/Restrictions
Applicant’s election of Group I (claims 1-6, 8-10, 12, 22, 23, 28 and 30) and species of SEQ ID NO:1-6 with X1=leucine, X2=aspartic acid and X3=alanine and condition associated with increased expression of NGF in the reply filed on 19 September 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is noted that the election was made “without prejudice”. However, this is not the same as “without traverse” and therefore, the response is considered incomplete as there is no assertion of with or without traverse. “Without prejudice” means that a communication or action is made without harming one’s legal rights or claims while “without traverse” means to agree to a formal requirement without formally denying it.
Claims 13, 15-16, 19-21 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 September 2025.
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.
The information disclosure statements (IDS) submitted on 01 November 2022 and 10 July 2025 have been considered by the examiner.
Drawings
The drawings are objected to because Figures 3-7 do not comply with 37 CFR 1.84(a)(1) and (b)(1).
Figures 3-6 are not in black ink as some of the lines and symbols are not composed of solid lines. This results in features not being clear or distinguishable (see screenshot example below):
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Figure 7 appears to be a photograph which is blurry and not of sufficient quality so that all details in the photo is reproducible.
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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the language “the present disclosure relates”. Additionally, the abstract is a single, run-on sentence rather than being in narrative form. 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).
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 title does not reflect the specifics of the invention to which the claims are directed as the claims are not directed to generic antigen-binding molecules or generic uses.
The disclosure is objected to because of the following informalities: the text at page 57 is not compliant with 37 CFR 1.52 (a)(1)(iv-v). See screenshots below:
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Clearly the text is not solid black and lacks sufficient clarity and contrast between the paper and the writing thereon. The fuzzy, pixilated nature of the text results in errors when attempts to OCR the text are made.
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 1-5, 10, 12, 22-23, 28 and 30 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 an antigen-binding molecule that binds to NGF and comprises a heavy chain variable domain and a light chain variable domain and wherein the HCV and LCV each comprise 3 CDRs having the amino acid sequences of SEQ ID NO:1-6. SEQ ID NO:2 contains one variable amino acid (X1) and SEQ ID NO:2 contains 2 variable amino acids (X2 and X3). X1 is leucine or “a conservative amino acid substitution thereof”, X2 is aspartic acid or “a conservative amino acid substitution thereof” and X3 is alanine or “a conservative amino acid substitution thereof”. The instant specification exemplifies antigen-binding molecules which have the functionality of binding to NGF wherein X1 is leucine or valine, X2 is aspartic acid or glutamic acid and X3 is alanine or valine. Antigen-binding molecules which possess these structures meet the written description requirement. The instant specification fails to provide an adequate written description of the full scope of the genus of antigen-binding molecules claimed which possess a conservative substitution at the noted positions and also which retain the ability to specifically bind NGF.
The structures of the antibodies claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., Ill USPQ2d 1780 (Fed. Cir. 2014) AbbVie had claims to functionally claimed antibodies and Centocor presented evidence that the antibodies described in AbbVie's patents were not representative of other members of the functionally claimed genus. The decision states, “When a patent claims a genus using functional language to define a desired result, ‘the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’ Id. at 1349. We have held that 'a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus.’ Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). Here, the claimed invention is a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human IL-12, a known antigen. AbbVie's expert conceded that the '128 and '485 patents do not disclose structural features common to the members of the claimed genus.”
The AbbVie decision considers how large of a genus is involved and what species of the genus are described in the patent. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and ... cover any compound later actually invented and determined to fall within the claim's functional boundaries.”).
In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The instant specification exemplifies antigen-binding molecules which have the functionality of binding to NGF wherein X1 is leucine or valine, X2 is aspartic acid or glutamic acid and X3 is alanine or valine. However, the claims encompass “conservative amino acid substitutions” at the named positions, and the structural variability of the claimed genus is large. As pointed out in the 112(b) rejection below, the metes and bounds of “conservative amino acid substitution” are not clear and there is no reasonable expectation that conservation of amino acid structure will provide the necessary functionality of binding NGF as the specification even states that the variant antigen-binding molecules would need to be screened for the ability to bind NGF. No reasonable structure-function correlation has been established that is commensurate in scope with the claims. The specification does not describe representative examples to support the full scope of the claims.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claim indicates that these claims are drawn methods which require antibodies which have specific functional characteristics.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing 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.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.” The specification provides a single example for each position recited which meets the functional limitations of the claims. Evidence of a genus is rarely supported by the disclosure of a single species within the genus.
Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genera of ADM-binding proteins based on disclosures set forth above. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the genus of antibodies which must be provided in the claimed method. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus, which are antibodies or fragments which have the recited characteristics pointed out above. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. 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).
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).
Applicant is referred to MPEP 2163(II)(3)(a):
For some biomolecules, examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. As explained by the Federal Circuit, "(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met … even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." Falkner v. Inglis, 448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006); see also Capon v. Eshhar, 418 F.3d at 1358, 76 USPQ2d at 1084 ("The Board erred in holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes" where the genes were novel combinations of known DNA segments.). However, the claimed invention itself must be adequately described in the written disclosure and/or the drawings. For example, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties) (emphasis added).
Claims 23 and 28 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.
Claims 23 and 28 are directed to methods of prevention by administration of an antigen-binding molecule that binds NGF. The specification defines “prevention” as preventing or delaying the onset of the condition, or the risk of developing the condition. The specification does not disclose any limiting criteria defining those subjects who are considered to be at risk of “the condition” nor are the conditions which are to be prevented clearly articulated.
The claims are not enabled for methods of prevention because if the conditions are caused by excess NGF, the skilled artisan would not be apprised of such excess in a way that would enable the administration of an antigen-binding molecule in a timely fashion to prevent such conditions. The specification does not teach how one would identify a subject in need thereof such a condition that an antigen-binding molecule could be administered before the condition begins. Next, the instant specification provides no examples of administering an antigen-binding molecule to prevent any disease or condition and the prior art would recognize that methods of prevention are unpredictable and rare. For example, there are no instances of any methods of preventing a tumour which is induced to proliferate by NGF. Furthermore, even if a tumour is induced to proliferate by NGF, the tumour may not be caused by NGF alone such that an antigen-binding molecule which binds NGF would not be sufficient to prevent the formation of the tumour to begin with. With regard to preventing a condition associated with increased expression/activity of NGF, again, there is no evidence of record that such a condition could be prevented by inhibition of NGF because although there may be an association, that does not mean that NGF is causative such that inhibition of NGF would prevent the condition. It is noted that arthritis is a condition indicated in the instant specification and one of ordinary skill in the art would not conclude that arthritis could be prevented by inhibition of NGF, absent evidence to the contrary. Therefore, the claims are not enabled for prevention.
Claims 23 and 28 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 23 is directed to a method of treating or preventing a condition associated with one or both of increased expression and increased activity of NGF. Claim 28 is directed to a method of treating or preventing a tumour induced to proliferate by NGF and conditions associated therewith. Both methods administer the antigen-binding molecule of claim 1 to a subject in need thereof. The limitation of prevention has been addressed in the preceding rejection, therefore, methods of treatment will be addressed in this ground of rejection.
The specification defines “treating” as relieving, reducing alleviating, ameliorating or otherwise inhibiting the condition, including one or more symptoms of the condition. The specification also states that “treating” includes relieving, reducing alleviating, ameliorating or otherwise inhibiting the condition for at least a period of time. The specification states that treating does not imply that the condition, or a symptom thereof, is permanently relieved, reduced, alleviated, ameliorated or otherwise inhibited and therefore also encompasses the temporary relief, reduction, alleviation, amelioration or otherwise inhibition of the condition, or a symptom thereof (see [0125]-[0126]). While the definitions in the specification do not require completely eliminating the condition, the definition does include completely eliminating the disorder, condition or symptoms associated therewith (i.e. cure).
The instant claims are directed to treating/preventing conditions “associated with” NGF expression/activity but the claims do not actually require the subject being treated to have increased expression/activity of NGF or a tumour induced to proliferate by NGF. The claims recite “to a subject in need thereof” but the claims are not limited to a subject with an NGF-related condition. Arthritis is a condition in which NGF increases pain sensitivity. In subjects with severe arthritis, depression can be a condition which is associated with NGF expression/activity. However, the instant claims are not enabled for treating depression in all subjects even though it has an association with NGF expression/activity in the context of arthritis because depression, in general, is not related to NGF expression/activity. The recitation of “to a subject in need thereof” does not specifically relate back to the NGF expression/activity or to the tumour as it also relates to an associated condition in the absence of NGF. The specification does not enable treatment/prevention of associated conditions as encompassed by the instant claims.
Claims 23 and 28 do not require any specific therapeutic effect for treatment. As such, claims 23 and 28 are considered to include curing a condition associated with increased expression/increased activity of NGF as well as curing a tumour induced to proliferated by NGF. The instant specification does not provide any examples which would enable the scope of the method claims for all therapeutic effects encompassed by “treatment” as defined by the instant specification.
It is suggested that the claims be amended to recite the particular therapeutic effect that must occur when treating a particular condition (e.g. inhibition of NGF stimulated tumour proliferation in a subject in need thereof or inhibition of pain in a subject with arthritis). Methods of inhibition of NGF by administration of the antigen-binding molecule of claim 6 would be enabled. The claims could then recite the specific patient population in need of inhibition such as those with an NGF-stimulated tumour or those with arthritis which would also be enabled.
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, 12, 23 and 28 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 is directed to an antigen-binding molecule that specifically binds to nerve growth factor and comprises 3 CDRs and wherein 2 CDRs contain wildcards X1, X2 and X3 which are specific amino acids or “a conservative amino acid substitution thereof”. This recitation is indefinite because the metes and bounds of “conservative amino acid substitution” are not clear. The specification at [0050] states:
[0050] A “conservative amino acid substitution” is to be understood as meaning a
substitution in which the amino acid residue is replaced with an amino acid residue having a similar side chain. Families of amino acid residues having similar side chains have been defined in the art, which can be generally sub-classified as shown in the table "Amino Acid Classification"
However, the information in this table is not consistent with the stated options for substitutions in claim 6; the options for X3 are listed as alanine or valine but the Table does not show that alanine and valine belong to the same sub-class. Furthermore, the Table at page 14 is not consistent with the table at page 13. Lastly, the specification states that:
Amino acid substitutions falling within the scope of the invention, are, in general, accomplished by selecting substitutions that do not differ significantly in their effect on maintaining (a) the structure of the peptide backbone in the area of the substitution, (b) the charge or hydrophobicity of the molecule at the target site, or (c) the bulk of the side chain. After the substitutions are introduced, the variants can be screened for their ability to bind specifically to NGF.
Therefore, even if an amino acid shares a similar side chain, it might not be a “conservative” substitution because the substitution will not necessarily conserve the functionality of the protein into which it is substituted. Therefore, the metes and bounds of “conservative amino acid substitution” is unclear.
Claim 12 recites “wherein the molecule is a humanized, caninized, felinized or equinized antibody or NGF-binding fragment thereof”. Claim 12 depends from claim 10 which limits the antigen-binding molecule to an antibody or an NGF-binding fragment thereof. Claim 12 is indefinite because it is not clear if the “humanized, caninized, felinized or equinized” limitation is meant to be applied to both the antibody and the NGF-binding fragment or if it is only applied to the antibody and therefore, claim 12 is directed to (1) a humanized, caninized, felinized or equinized antibody or (2) NGF-binding fragment thereof. If the “humanized, caninized, felinized or equinized” limitation is meant to be applied to the NGF-binding fragment, this limitation might not be further limiting as the NGF-binding fragment does not necessarily comprise framework which could be altered in this manner as claim 10 depends from claim 1 which only recites CDR structure.
Claim 23 recites a “method of treating or preventing a condition associated with one or both of increased expression and increased activity of NGF”. The metes and bounds of what condition would be “associated with” increased expression and/or increased activity of NGF cannot be ascertained. First, the metes and bounds of what “increased activity of NGF” is unclear. Does this mean that the NGF is more active for some reason such as having a higher affinity for a receptor or upon binding a receptor, it elicits a greater stimulation of activity or does it only mean that there is more of the protein in circulation? If the later, then it is not clear what the difference between increased activity and increased expression would be. Next, the metes and bounds of what kind of association would be necessary for a condition to be encompassed by the claims is unclear and indefinite. Lastly, the mere fact that a condition may be associated with increased expression/activity of NGF does not necessarily mean that such a condition would be one that could be treated by administration of an antigen-binding molecule that binds NGF so the metes and bounds of which conditions are encompassed by the claims is not clear and the claims are indefinite.
Claim 28 recites a method of treating or preventing a tumour induced to proliferate by NGF and “conditions associated therewith”. The metes and bounds of “conditions associated therewith” are unclear and one of ordinary skill in the art would not know which conditions are encompassed by the claims. The degree of association is not stated nor it is clear what kind of association would be required or necessary to be included in the claims.
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.
Claim 30 is 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 30 depends from claim 1 and is directed to a kit which comprises the antigen-binding molecule of claim 1, which does not limit the subject matter of claim 1. Claim 30 also recites in the alternative, “or an NGF-binding fragment thereof”. However, this also does not limit the subject matter of claim 1 as claim 1 is directed to an antigen-binding molecule which must comprise a heavy chain variable region and a light chain variable region and wherein each variable region comprises 3 CDRs. The recitation of “or an NGF-binding fragment thereof” does not further limit that subject matter as the antigen-binding molecule already binds NGF and it also already is a “fragment” of an antibody as it comprises the heavy and light chain variable regions of an immunoglobulin. In so far as the NGF-binding fragment is something less than that of claim 1, it would not be properly dependent as it would not include all the limitations of the claim from which it depends. If it is an alternate embodiment for claim 30, it would not further limit the subject matter of the claim from which it depends. 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.
Allowable Subject Matter
Claims 6 and 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The art does not fairly teach or suggest an antigen-binding molecule which binds to NGF which comprises 6 CDRs having the amino acid sequences of SEQ ID NO:1-6 wherein X1 is leucine or valine, X2 is aspartic acid or glutamic acid and X3 is alanine or valine. Specifically, the CDR having the amino acid sequence of SEQ ID NO:1 differs from the prior art by a single amino acid at position 2 of SEQ ID NO:1. The instant specification discloses that this difference enhances expression of the recombinant antigen-binding molecule compared to the rat-derived αD11 antibody (WO 2006/131951) (see [0008] of the instant specification).
The antigen-binding molecule of claim 6 differs from the antigen-binding molecule of U.S. Pat. No. 12,065,487 (closest prior art) by a single amino acid at position 2 of SEQ ID NO:1. The amino acid at this position in the instant application is leucine while the amino acid at this position in ‘487 is phenylalanine. As stated above, the CDR with leucine at position 2 results in enhanced expression compared to the parent antibody αD11.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Aloe et al. Nerve Growth Factor: role in growth, differentiation and controlling cancer cell development. J. Exp. Clin. Can. Res. (2016) 35:116.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571)272-0857. 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