Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
Claims 24, 30-31, 34, 37-38, 47-48, 50-51, and 53-54 are pending in the instant application.
Priority
This application is a 371 of PCT/US2018/041291, filed on 7/9/2018.
Withdrawn Rejections
The rection of claims 24-31, 34-38, and 46-54 under § 103 is withdrawn in light of the applicant’s arguments; the requirement for the conjugate to comprise an antibody with (i) a means of binding CD5 and (2) an ALK5 inhibitor was not found in the prior art. A person of skill in the art would not have been motivation to combine these elements in an antibody drug conjugate, absent the teachings of the instant application.
The non-statutory double patenting rejection over US11583593 has been withdrawn; the combination of references fails to claim or motivate conjugating an ALK5 inhibitor to an antibody.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/10/2025 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
claim 24
In claim 24, the limitation (b) “means for binding CD5” and (c) “means for covalently connecting the ALK5 inhibitor … to the antibody” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Regarding (b) Applicant has provided a single exemplary anti-CD5 antibody, but has not described the binding region of that antibody that is responsible for binding CD5 (e.g. the complete set of six CDRs). See the related 112(a) rejection regarding this limitation failing to meet the written description. Furthermore, because the claim is drawn to any means of binding CD5, it is not limited to the antigen binding region of an antibody, thus could also refer to a tethered small molecule or ligand that binds CD5—of which applicant has provided zero examples of. Hence, the disclosure is devoid of any structure within this category that performs the function.
Regarding (c) Applicant has failed to provide any complete chemical structures or even complete formulas of the instantly claimed invention, thus no examples have been provided of what the specific “means” of connecting the antibody to the ALK5 inhibitor is. Applicant only describes what an optional linker may comprise (e.g. maleimidocaproyl or ValCit) and that any generic cysteine or lysine residue on the antibody can serve as a point of attachment (pg 79, Table 7). However, maleimidocaproyl is only compatible with conjugation at cysteine and not lysine. Whereas ValCit is not compatible with direct conjugation with either cysteine or lysine. On the ALK5 inhibitor itself, Applicant has not described which atom of this molecule serves as the point of attachment for the linker. Applicant’s claimed “means covalently connecting the ALK5 inhibitor to one or more cysteine or lysine residues” is not limited to linkers, however only portions of a linker have been described. Taken together, the structures described in the specification do not perform the entire function of the claim. Dependent claims 30-31, 34, 37-38, 47-48, 50-51, and 53-54 fail to cure these deficiencies, thus are also rendered indefinite.
Therefore, the claim is indefinite and is objected to under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections – 35 USC § 112(b)
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 24, 30-31, 34, 37-38, 47-48, 50-51, and 53-54 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 24
Claim 24 is drawn to “an antibody comprising means for binding CD5”, wherein there is no disclosure of the structure for performing the recited function. MPEP § 2181 (II)(A) recites “[a] bare statement that known techniques or methods can be used does not disclose structure” in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007).” Because applicant has not defined what structure is responsible for the function of binding CD5, and applicant is instead relying on the skilled artisan to apply “known methods” of achieving this function, this claim is rendered indefinite. Dependent claims 30-31, 34, 37-38, 47-48, 50-51, and 53-54 fail to cure these deficiencies, thus are also rendered indefinite.
claim 24
Claim 24 is drawn to “a means for covalently connecting the ALK5 inhibitor to one or more cysteine or lysine residues on the antibody”, wherein there is no disclosure of the structure for performing the recited function. MPEP § 2181 (II)(A) recites “[a] bare statement that known techniques or methods can be used does not disclose structure” in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007).” Because applicant has not defined what structure is responsible for the function of linking the ALK5 inhibitor to the antibody, and applicant is instead relying on the skilled artisan to apply “known methods” of achieving this function, this claim is rendered indefinite. Dependent claims 30-31, 34, 37-38, 47-48, 50-51, and 53-54 fail to cure these deficiencies, thus are also rendered indefinite.
Claim Rejections – 35 USC § 112(a)
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 24, 30-31, 34, 37-38, 47-48, 50-51, and 53-54 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.
all claims
Claim 24 is drawn to an antibody “comprising the means for binding CD5” (e.g. an anti-CD5 antibody). As written the claim is not limited to the antigen-binding region of an antibody, but any means of binding CD5 (e.g. small molecule or ligand). The specification as filed fails to provide an adequate written description of this genus. Even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity. Furthermore, note in the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen.” Because applicant cannot meet the written description of antibodies or antigen-binding fragments thereof via a representative number of species, applicant must instead (i) provide the core structure of the antibodies/antigen binding fragments that preserve the function of binding CD5, such as a complete set of 6 CDRs (e.g. CDRs comprising SEQ ID NOs: 1-6); or (ii) provide the names of antibodies known to target T cells with defined amino acid structures (e.g. OKT11 or muromonab). In the instant case, applicant has described a single anti-CD5 antibody (rat anti-mouse CD5 antibody, clone 53-7.3, Southern Biotech, Catalog# 1547; Example 15; Table 7). Thus applicant has failed to demonstrate possession of all means of binding CD5 known and yet to be discovered. Dependent claims 30-31, 34, 37-38, 47-48, 50-51, and 53-54 fail to cure these deficiencies, thus also fail to satisfy the written description requirement.
Non-Statutory 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.
17/620222
Claims 24, 30-31, 34, 37-38, 47-48, 50-51, and 53-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-48 of copending Application No. 17/620222 in view of Beria et al. (US9695240). This is a provisional nonstatutory double patenting rejection.
claim 24, 31, 48, 51, 54
Regarding instant claims 24, 31, 48, 51, and 54 the reference claims conjugating an ALK5 inhibitor to a protease sensitive linker, wherein the ALK5 inhibitor has the structure C (claim 29), shown below.
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The reference claims the conjugate as a method of treating cancer when conjugated to a T-cell targeting moiety, such as an antigen binding fragment/antibody targeting CD5 (claim 26, 39)
claim 30, 47, 50, 53
Regarding instant claims 30, 47, 50, and 53, the reference claims compound B (claim 28).
claim 34
Regarding claim 34, the reference claims their conjugate is effective in treating solid tumors (claim 42).
claim 37
Regarding claim 37, the reference does not teach administering the conjugate as a monotherapy.
Barbeau teaches the method of administering the conjugate as a monotherapy (claim 10). Barbeau teaches a method of treating cancer comprising administering a glycoconjugate comprising an ALK5-inhibitor drug and a Muc4-targeting glycan (pg 2, para 0010; abstract). Barbeau teaches that Muc4 is overexpressed on a variety of tumor cell types (abstract), typically in a membrane-bound form (pg 1, para 0004). Barbeau teaches the ALK5-inhibitors are conjugated to the glycan through a covalent linker (abstract). Barbeau teaches the ALK5 inhibitor comprises the structure below on the left (pg 5, para 0024), wherein R10 isa C1 alkyl group and R9 is hydrogen (pg 6, para 0024). Barbeau teaches the compound: 4-(3-methylpyridin-2-yl)-5-(1,5-naphthyridin-2-yl)thiazol-2-amine (pg 11, para 0334; shown below). Thus meeting the limitation of the instantly claimed structure A (right side).
It would have been obvious to combine the teachings of the Barbeau and the reference because (1) Barbeau teaches ALK5 inhibitors can be conjugated to a Muc4 glycan to treat cancer and are effective as a monotherapy; and (5) the reference also claims the conjugates are useful in treating cancer. Taken together, the Muc4-targeting glycan of Barbeau meets the limitation of comprising a moiety that targets T cells. Thus one of skill in the art need only replace the Muc4 targeting glycan of Barbeau, and replace it with the anti-Muc4 or anti-CD25 targeting antibody to arrive at the instantly claimed invention. One of skill in the art would have had a reasonable expectation of success because Barbeau and Mizejewski teach that ALK5-inhibitors conjugated to T-cell targeting moieties are effective in treating cancer and Gary supplies another T-cell targeting moiety in antibody form that is also effective in treating cancer.
claim 38
Regarding claim 38, the reference claims administering the conjugate as a combination therapy with a checkpoint inhibitor (claim 26).
Allowable Subject Matter
A claim drawn to:
“A method of treating cancer, comprising administering to a subject in need thereof an antibody drug conjugate of the formula
Ab-(Lx-D)y
wherein
Ab is an anti-CD5 antibody;
L is a linker;
x is 0-1;
y is 2-8; and
D is an ALK5 inhibitor of the structure
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wherein *H corresponds to a covalent bond or a hydrogen atom.”
The closest prior art is that of Barbeau (US20120022016) who teaches the compound 4-(3-(pyridin-2-yl)-1H-pyrazol-4-yl)-2-(4-(2-(pyrrolidin-1-yl)ethoxy)phenyl)pyridine (pg 7, para 0130; shown below) as a means of treating cancer when conjugated to a Muc4-targeting glycan (abstract).
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Barbeau teaches the pyrrolidine moiety above (arrow) as an exemplary alkylamine under variable R6, which is optionally an alkylamine comprising 1-5 carbons (pg 5, para 0022).
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Barbeau does not teach conjugating said ALK5 inhibitors to antibodies of any sort. The prior art is absent the combination of an antibody and an ALK5 inhibitor as a means of treating cancer.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
112(a); pg 6
Applicant argues inclusion of the limitation “means for covalently connecting the ALK5 inhibitor to one or more cysteine or lysine residues on the antibody” meets the written description requirement for an antibody or antigen-binding fragment comprising a means for binding CD5. Applicant argues this “means plus function language” is sufficient to meet the requirements of 112(f). Applicant cites MPEP § 2181(II)(A). Applicant cites McCombs as purportedly suggesting that any cysteine or lysine residue on any antibody can be conjugated to any drug.
At issue is not the written description for the linker, but the lack of written description for the antibody portion. In the instant case, applicant has described a single anti-CD5 antibody (rat anti-mouse CD5 antibody, clone 53-7.3, Southern Biotech, Catalog# 1547; Example 15; Table 7), but has not reported the structure of that antibody, nor is it available from the manufacturer’s website. Secondly, applicant has not described a complete exemplary structure, which is the subject of the newly added 112(f) issue.
The means-plus-function requirements were found deficient in light of the specification because the instantly claimed invention requires covalently linking the ALK5 inhibitor to the antibody to form a conjugate, as opposed to merely combining them separately or sequentially; and Applicant describes one exemplary anti-CD5 antibody using a cleavable VC linker and a non-cleavable MC linker. However, Applicant has failed to describe the genus of all anti-CD5 binding antibodies given this single example. While the claims encompass ADCs that lack a linker (e.g. directly bound to an existing lysine residue), Applicant has failed to provide a single working example of species within this genus. Applicant has also failed to describe where in their exemplary anti-C5 antibody, where the AKL5 inhibitors may be linked so as to form an effective ADC. Thus even the one working example is lacking clarity in this regard. Applicant also notes “the data also indicates that the linker attaching the ALK5 inhibitor to the antibody and the release mechanism are both important for efficacy” (pg 80, para 0274). No artisan would reasonably conclude that generic knowledge in the art concerning known linkers, known anti-CD5 antibodies, and known conjugation methods allow them to envisage the genus of all functional anti-CD5 ALK5-inhibtor conjugates of the invention. McCombs (doi: 10.1208/s12248-014-9710-8) teaches that effective ADCs must achieve a drug-antibody ratio (DAR) that incorporates a sufficient number of drug molecules without negatively affecting antigen binding in order to be successful (pg 339, col 1, para 1). McCombs also teaches that not any conjugation approach is effective, absent a site-selective approach, extensive purification is required to afford a predictable and homogenous conjugate (pg 340, col 1, para 4-5). McCombs corroborates applicant’s finding that the linker is critical to the function of the antibody (pg 344, col 1, para 2). McCombs teaches
“ultimately the optimal combination of linker and conjugation chemistry must be uniquely tailored to correlate each unique facet: the antibody, the drug molecule, and the profile of the disease to be treated.” (pg 344, col 2, para 1).
Thus the claims as written require structural limitations that are not described within the claim in order for the invention to function. In other words, Applicant has placed the burden on the practitioner to discover which species of the invention have the purported function. To meet the requirements of 112, “the corresponding structure must be disclosed in the specification itself in a way that one skilled in the art will understand what structure will perform the recited function”. The instant specification provides one exemplary anti-CD5 antibody, and points to generic teachings in the literature regarding suitable linkers and conjugation sites that are non-specific to the anti-CD5 antibody used (pg 7, para 0035-0036). Applicant points to generic options of the linker being optionally cleavable (pg 7, para 0037). Applicant does not disclose where the ALK5 inhibitor was attached to the exemplary antibody.
MPEP § 2181 (II)(A) recites:
“If there is no disclosure of structure, material or acts for performing the recited function, the claim fails to satisfy the requirements of 35 U.S.C. 112(b). The disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997). However, “[a] bare statement that known techniques or methods can be used does not disclose structure” in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007) (Disclosure that an invention “may be controlled by known differential pressure, valving and control equipment” was not a disclosure of any structure corresponding to the claimed “control means for operating [a] valving ” and the claim was held indefinite). See also Budde v. Harley-Davidson, Inc., 250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806 (Fed. Cir. 2001); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1115-18, 63 USPQ2d 1725, 1731-34 (Fed. Cir. 2002) (Court interpreted the language of the “third monitoring means for monitoring the ECG signal…for activating …” to require the same means to perform both functions and the only entity referenced in the specification that could possibly perform both functions is the physician. The court held that excluding the physician, no structure accomplishes the claimed dual functions. Because no structure disclosed in the embodiments of the invention actually performs the claimed dual functions, the specification lacks corresponding structure as required by 35 U.S.C. 112, sixth paragraph, and fails to comply with 35 U.S.C. 112, second paragraph.).”
In essence, applicant’s disclosure, is a bare statement that known techniques or methods can be applied to known anti-CD5 antibodies in order to generate a population of wholly functional conjugates. This argument was found insufficient in light of the teachings of McCombs who teach using said generic conjugation methods requires experimentation to identify the functional exemplary species (e.g. conjugates that still have the requisite binding activity and are able to deliver sufficient quantities of drug in order to affect the particular disease). Hence applicant has failed the written description requirement.
The cited paragraph of McCombs refers to subpopulation of three FDA-approved ADC’s, thus contrary to Applicant’s assertions, does not constitute a teaching for universally accepted points of conjugation that are functional on any antibody. This argument is based on a misinterpretation of what McCombs has stated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675