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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 9/24/2025 has been entered.
Claims 2, 5-172, 175, and 178-187 have been cancelled.
Applicant's arguments filed 9/24/2025 have been fully considered but they are not persuasive.
Election/Restrictions
Claim 173 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/27/2023.
Claims 1, 3-4, 174, 176-177, and 188-192 are under consideration.
CLAIM INTERPRETATION
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitations recite sufficient structure, materials, or acts to entirely perform the recited function.
Independent claim 1 as currently amended is directed (in part, with certain limitations underlined by the examiner) to a method of detecting a target antigen by optical detection, comprising:
(ii) contacting said first antibody with a means for detection of said first antibody, wherein said means specifically binds and detects said first antibody, wherein said means
comprises: one or more fluorescent label(s) attached to said means; and
(iii) detecting said target antigen by optically detecting said one or more fluorescent label(s); wherein
(a) said first antibody is guinea pig IgG and said means which specifically binds and detects said first antibody specifically binds guinea pig IgG and is not cross-reactive to the following antibody species: mouse IgG, rat IgG, chicken IgY, rabbit IgG, human IgG, human IgM, goat IgG, donkey IgG, pig IgG, horse IgG, and cattle IgG…
As written, claim 1 is unclear whether the function of the means is (a) only detects or (b) both specifically binds and detects. Dependent claims 3-4, 174, 176, 177, and 188 appear to intend (b). Alternatively, applicant may have intended two means, one means that specifically binds and one means that specifically detects. That is, the function(s) that must be performed by the means in claim 1 are not clear. In particular, the phrase “said means
comprises: one or more fluorescent label(s) attached to said means” is circular language. The language is unclear as to whether the “means” of the claim includes or excludes one or more fluorescent label(s). Note that the current recitation of “said means comprises: one or more fluorescent label(s) attached to said means” is distinct from a recitation of “where one or more fluorescent label(s) are attached to said means” (e.g. the means itself excludes one or more fluorescent labels), for example.
Independent claim 189 as currently amended is directed (in part, with certain limitations underlined by the examiner) to a method of detecting a target antigen by optical detection, comprising:
contacting said first antibody
(a) that is a guinea pig IgG with a means for binding guinea pig IgG without cross-reacting to any one of the following antibody species: mouse IgG, rat IgG, chicken IgY, rabbit IgG, human IgG, human IgM, goat IgG, donkey IgG, pig IgG, and horse IgG, wherein the means comprises one or more fluorescent label(s) attached thereto; … and
detecting said target antigen by optically detecting the one or more fluorescent label(s).
As written, claim 189 is unclear whether the function of the means is (a) only binds or (b) both specifically binds and detects. Dependent claims 190-192 appear to intend (a); however, the means in claim 189 must also have the function of detection in view of the last line of the claim. In particular, the phrase “means comprises one or more fluorescent label(s) attached thereto” is circular language. The language is unclear as to whether the “means” of the claim includes or excludes one or more fluorescent label(s). Note that the current recitation of “means comprises one or more fluorescent label(s) attached thereto” is distinct from a recitation of “where one or more fluorescent label(s) are attached to said means” (e.g. the means itself excludes one or more fluorescent labels), for example.
In any event, the “one or more fluorescent label(s)” recited in the claims is a sufficient structure or material to perform the detection function. As such, the claims are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitations do not recite sufficient structure, materials, or acts to perform the claimed function.
Applicant is referred to MPEP 2181 with respect to proper means plus function limitations in claims, particularly MPEP 2181(1)(C). It is noted that the originally filed specification and claims did not disclose any means plus function language or concepts. Furthermore, the specification does not provide specific structures clearly linked to the recited function for all means recited in the claims.
Applicant is advised that in the event the claims are ever amended to properly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 35 U.S.C. 112(f) states that a claim limitation expressed in means- (or step-) plus-function language "shall be construed to cover the corresponding structure…described in the specification and equivalents thereof." "If one employs means plus function language in a claim, one must set forth in the specification an adequate disclosure showing what is meant by that language. If an applicant fails to set forth an adequate disclosure, the applicant has in effect failed to particularly point out and distinctly claim the invention as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA section 112 ]." In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc).
The instant specification does not set forth an adequate disclosure showing what is meant by that language. In particular, there are no specific corresponding structures disclosed in the specification for claim 1, parts (d)-(f). For the particular camelid single domain antibodies of SEQ ID NOS: 4, 12, and 16, there would have been no known equivalents at the time of the effective filing date. Note that known equivalents are not any camelid single domain antibody. The known equivalents must have the required binding properties recited in the claims. The means being claimed have specialized functions. The claims include multiple means with multiple functions. See for example, claim 1 where the means for part (a) would not be the same means as for part (b). At least for example, the binding function for the means of part (a) includes multiple binding requirements for guinea pig IgG, mouse IgG and so forth and the binding function for the means of part (b) includes multiple different binding requirements as compared to part (a).
A successful invocation of 35 U.S.C. 112(f) does not exempt an applicant from compliance with 35 U.S.C. 112(a) and 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, first and second paragraphs. See Donaldson, 16 F.3d at 1195, 29 USPQ2d at 1850; In re Knowlton, 481 F.2d 1357, 1366, 178 USPQ 486, 493 (CCPA 1973) ("[The sixth paragraph of section 112] cannot be read as creating an exception either to the description requirement of the first paragraph … or to the definiteness requirement found in the second paragraph of section 112. Means-plus-function language can be used in the claims, but the claims must still accurately define the invention.")
See at least MPEP 2181(II)(A).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, 174, 176-177, and 188-192 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 confusing in reciting a “means for detection” where the dependent claims recite a “means for binding and detection.” The phrase “means comprises one or more fluorescent label(s) attached thereto” is circular language and is confusing. The language is unclear as to whether the “means” of the claim includes or excludes one or more fluorescent label(s).
Claim 188 depends upon claim 177. Claim 177 requires that the first antibody is a human IgM. Claim 188 is confusing as it recites “when said first antibody is human IgG.” This is in conflict with claim 177. The claim is not properly dependent.
Claim 189 is confusing as to whether the function of the means is (a) only binds or (b) both specifically binds and detects. Dependent claims 190-192 appear to intend (a); however, the means in claim 189 must also have the function of detection in view of the last line of the claim. The phrase “means comprises one or more fluorescent label(s) attached thereto” is circular language and confusing. The language is unclear as to whether the “means” of the claim includes or excludes one or more fluorescent label(s).
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, 3-4, 174, 176-177, and 188-192 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of detecting using SEQ ID NO: 4, SEQ ID NO: 12, or SEQ ID NO: 16 as a second antibody that is a camelid single domain antibody that is itself the means for binding (see for example claim 189, parts (a), (b), and (c)) or is part of the means that specifically binds and detects (see for example claim 1), does not reasonably provide enablement for all methods embraced by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Contrary to applicant’s 9/24/2025 arguments, applicant has not invoked 35 USC 112(f) means plus function language for the reasons set forth above.
Paragraph [0111] discloses the particular camelid sdAbs of SEQ ID NO: 4 (camelid sdAb that is anti-guinea pig IgG), SEQ ID NO: 8 (camelid sdAb that is anti-chicken IgY), SEQ ID NO: 12 (camelid sdAb that is anti-rat/mouse IgG), and SEQ ID NO: 16 (camelid sdAb that is anti-human IgM). SEQ ID NO: 8 is not encompassed by the current claims.
Paragraph [0061] of the specification discloses that an “antibody or antibody molecule/fragment is said to ‘specifically’ bind to an antigen when it recognizes its target antigen within a complex mixture of proteins and/or macromolecules. Typically, the antibody is capable of specifically interacting with and/or binding to its target but does not essentially bind to another epitope or antigen.”
The specification does not provide a definition for “cross-reactive” and as such, the claims are interpreted to mean than “not cross-reactive” means no binding to the recited antigens (e.g. mouse IgG, rat IgG, etc.).
One of ordinary skill in the art must have the second antibody that is a camelid single domain antibody that is itself the means for binding (see for example claim 189, parts (a), (b), and (c)) or is part of the means that specifically binds and detects (see for example claim 1) in hand as a reagent in order to practice the claimed method of detecting a target antigen.
The genus of second antibodies having the properties recited in the claims is not enabled. As such, the claimed methods cannot be practiced and the methods are not enabled.
Example 1 at paragraph [0137] references Figure 4. Amino acids 10-130 of SEQ ID NO: 17 correspond to SEQ ID NO: ID 4 (camelid sdAb that is anti-guinea pig IgG). SEQ ID NO: 4 has not been disclosed as lacking cross-reactivity to cattle IgG as required by claims 176 and 187. Example 2 at paragraph [0140] references Figure 5 and the sdAb of SEQ ID NO: 19 which has a 3xFLAG-tag and GFP derivative on the C-terminus. Amino acids 9-129 of SEQ ID NO: 19 correspond to SEQ ID NO: 12 (camelid sdAb that is anti-rat/mouse IgG). Figure 5 establishes the enablement of SEQ ID NO: 12 as a second antibody meeting the limitations of claim 1, part (b), but not claims 176 and 187 or claim 1, part (f). Note cross-reactivity to mouse IgG. Example 3 at paragraph [0142] references Figure 6A. Amino acids 10-2125 of SEQ ID NO: 20 correspond to SEQ ID NO: 16 (camelid sdAb that is anti-human IgM). SEQ ID NO: 16 is disclosed as having cross-reactivity to human IgG; however, it meets the limitations of the claim 1, part (c), and claim 177. It does not meet the limitations of claim 189, part (a), or claim 190 in view of the cross-reactivity to human IgG.
The specification does not establish that the camelid sdAbs used as secondary antibodies in Examples 4 and 7 (i.e. the anti-guinea pig IgG sdAb of SEQ ID NO: 17 in Example 4; the different anti-mouse IgG sdAbs (structure unknown) in Example 7) have a non-cross-reactivity profile as defined in the claim 1 or 189. The non-cross-reactivity profile of the anti-chicken IgY sdAb (SEQ ID NO: 18) in Example 6 is also not known; however, chicken IgY sdAbs are not encompassed by the current claims. These sdAbs do not meet the limitations of the claims.
The specification enables only SEQ ID NOS: 4, 12 and 16 as particular camelid sdAbs (second antibodies of the claims) as having the lack of cross-reactivity required by the claims. However, it would constitute undue experimentation to make and/or identify all camelid sdAbs (second antibodies of the claims) having the lack of cross-reactivity required by the claims. Paragraph [0083] of the specification indicates that the antibodies can be generated by methods known in the art, referring for example to Pleiner et al. (2015; 4:e11349, of record). A reference to a general technique for fluorescently labeling nanobodies does not enable particular products with particular structural characteristics that are required by the claims.
The specification identified no antibodies meeting the limitations of claim 1, parts (d) and (e), and (f).
In In re Wands (8 USPQ2d 1400 (CAFC 1988)) the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation." These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims.
The direction or guidance in the specification is limited to a disclosure that one of ordinary skill in the art could make camelid antibodies and screen them. See also Luis Felipe Opazo Davila 37 CFR 1.132 Declaration which also concerns making and testing antibodies. With respect to the state of the art, applicant has argued that prior to the effective filing date, camelid sdAbs having such a low extent of cross-reactivity as recited in claim 1 were not known in the art. See at least 6/28/2023 response at page 17, second full paragraph. The claims are broad and encompass any anti-guinea pig IgG camelid sdAb having the non-cross-reactivity recited; any anti-mouse or rat IgG camelid sdAb having the non-cross-reactivity recited; any anti-human IgM camelid sdAb having the non-cross-reactivity recited. any anti-rabbit IgG camelid sdAb having the non-cross-reactivity recited, any anti-goat IgG camelid sdAb having the non-cross-reactivity recited, and any anti-rat IgG camelid sdAb having the non-cross-reactivity recited. A single anti-guinea pig IgG (SEQ ID NO: 4) is enabled by the specification. A single anti-mouse or rat IgG camelid second antibody (SEQ ID NO: 12) is enabled by the specification. A single anti-human IgM camelid second antibody (SEQ ID NO: 16) is enabled by the specification. Given the breadth and limitations of the claims, a large amount of experimentation would be necessary to make or identify second antibodies meeting the functional limitations of the claims. One of ordinary skill in the art would have to generate camelid sdAbs against guinea pig IgG (claim 1, part (a), and claims 174, 189-190), mouse or rat IgG (claim 1, part (b), and claims 176, 189, 191), human IgM (claim 1, part (c), and claims 177, 188, 189, and 192), rabbit IgG (claim 1, part (d)), goat IgG (claim 1, part (e)), rat IgG (claim 1, part (f)) and from these sets of antibodies determine which camelid sdAbs were specific for guinea pig IgG, mouse or rat IgG, and human IgM. From these subsets, one of ordinary skill in the art would have to screen for the presence or absence of cross-reactivity to each of the antibody species recited in the claims. Large numbers of camelid sdAbs would be generated and one of ordinary skill in the art would have expected the number specific for each of guinea pig IgG, mouse/rat IgG, and human IgM etc. to be numerous. It is unknown how common or rare second antibodies meeting the limitations of the claims would be as the specification has identified only SEQ ID NOS: 4, 12, and 16, paragraph 69 of the Luis Felipe Opazo Davila 37 CFR 1.132 Declaration notwithstanding. The declaration does not disclose or specifically identify any of the “large numbers of species-specific non-cross-reactive sdAbs for immunoglobulins from many different animal species” as asserted in paragraph 69. It is not known how many constitutes a “large number” or how many species constitutes the “many different animal species,” particularly with reference to the claimed camelid single domain antibodies. That is, the declaration makes assertions but provides no evidence supporting those assertions.
Paragraphs 50-51 of the declaration reference Exhibit C. Figure 1 discloses an anti-Rat IgG conjugated with Sulfo-Cyanin 3. Exhibit C and Figure 1 do not identify the structure of the anti-Rat IgG or any cross-reactivity (or lack of cross-reactivity) for this sdAb. Figure 2 discloses an anti-Goat IgG labeled with Cy5. Exhibit C and Figure 2 do not identify the structure of the anti-Goat IgG or any cross-reactivity (or lack of cross-reactivity) for this sdAb. Figure 4 discloses an anti-Rabbit IgG labeled with Sulfo-Cyanin 3. Exhibit C and Figure 4 do not identify the structure of the anti-Goat IgG or any cross-reactivity (or lack of cross-reactivity) for this sdAb. Figure 5 discloses an anti-Mouse IgG conjugated with Atto 488. Exhibit C and Figure 5 do not identify the structure of the anti-Mouse IgG or any cross-reactivity (or lack of cross-reactivity) for this sdAb. Figure 6 discloses an anti-Guinea pig IgG directly coupled to Cy3.. Exhibit C and Figure 6 do not identify the structure of the anti-Guinea pig IgG or any cross-reactivity (or lack of cross-reactivity) for this sdAb. It is unknown if any of these sdAb meet the limitations of the claims or correspond to either of SEQ ID NOS: 4 or 12.
The methods disclosed in paragraphs 22-27 of the declaration are general and not specific. This would have required one of ordinary skill in the art to exercise inventive skill and independent judgment in order to identify camelid single domain antibodies meeting the limitations of the claims.
It is noted that paragraph [0083] of the specification does not specifically guide one of ordinary skill in the art to the screening method steps that applicant has argued were successful. Paragraph [0083] states that it “is also possible to include negative selection steps.” The declaration of Dr. Luis Felipe Opazo Davila implies that this is necessary for success. “Blocking” and “pre-deletion” steps are not disclosed by the instant specification as being preferred or necessary. This is what one of ordinary skill in the art would have understood. The specification does not guide one away from Pleiner et al. or to include particular screening steps. Paragraph [0083] discloses that the method of Pleiner et al. was an acceptable method. This is what one of ordinary skill in the art would have understood. The declaration does not tie all of the statements concerning what “one of ordinary skill in the art would have understood” to the actual disclosure of the specification.
It is noted that the Jackson ImmunoResearch Laboratories note from 2 August 2018 (referenced as Exhibit B in paragraph 48 of the declaration) would have been well after the effective filing date and does not reflect what would have been known at the time of the invention. This application is a 371 application where the PCT was filed 14 March 2018 and claims priority to a European patent application filed 14 March 2017. The claims must be enabled as of the effective filing date.
It is not considered to be so predictable to make or identify second antibodies having meeting the functional limitations of the claims as no structural characteristics or quality common to every functional embodiment has been disclosed and the instant specification has disclosed no specific second antibody having the functional features of the claims commensurate in scope to the claims. Undue experimentation would have been required.
The Supreme Court in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) held that Amgen’s broad antibody claims were not enabled. An outline of a method for generating antibodies having the characteristics required by the claims amounted to little more than a trial-and-error process of discovery that did not meet the standard for enablement. A disclosure or argument that one of ordinary skill in the art could make antibodies and screen for those having the desired properties was not sufficient for enablement. This is on point with the fact pattern in the instant application. In addition, the Supreme Court noted that Amgen had not disclosed a quality common to every functional antibody embodiment which is analogous to the instant fact pattern.
Applicant’s claims sweep much broader than the two second antibodies of SEQ ID NOS: 12 and 16, even allowing for a reasonable degree of experimentation. Applicant seeks to monopolize an entire class of things defined by their function, including a vast number of additional second antibodies beyond SEQ ID NOS: 4, 12, and 16.
The scope of the claims is not enabled. The various genuses of camelid single domain antibodies embraced by the various subparts of the claims are not enabled.
Applicant’s arguments are unpersuasive. Again, applicant has not invoked 35 USC 112(f) means plus function language.
The Luis Felipe Opazo Davila 37 CFR 1.132 Declaration was considered and addressed as set forth above. The statement on page 12 of applicant’s response “Applicant is entitled to presume that the evidence of Dr. Luis Felipe Opazo Davila is accepted by the Examiner” is noted. In response to this statement, the examiner acknowledges the assertions and opinions set forth in the declaration. The evidence of the declaration is addressed above. The weight of the evidence does not support a determination of enablement for the full scope of the claims. The declaration is insufficient to overcome the scope of enablement rejection.
Claims 1, 3-4, 174, 176-177, and 188-192 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 claims contain 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.
Contrary to applicant’s 9/24/2025 arguments, applicant has not invoked 35 USC 112(f) means plus function language for the reasons set forth above.
The claims as amended are now are directed to generic (1) means for detection and (2) means for specifically binding and detecting and (3) means for binding. The instant specification does not disclose any generic means and the claims are not limited to camelid single domain antibodies having particular binding properties (with or without one or more fluorescent label(s) attached). The claims as currently amended now include any product (conventional antibody, binding protein, chemical compound, etc. that has the binding characteristics recited in the claims. The claims constitute new matter.
While the claims have been amended to remove recitations to camelid single domain antibodies, the claims still in encompass these embodiments as a means for binding.
One of ordinary skill in the art must have the second antibody that is a camelid single domain antibody that is itself the means for binding (see for example claim 189, parts (a), (b), and (c)) or is part of the means that specifically binds and detects (see for example claim 1) in hand as a reagent in order to practice the claimed method of detecting a target antigen.
The genus of camelid single domain, i.e. a second antibody functioning as the “means” encompassed by the claims and having the properties recited in the claims is not adequately described. As such, the claimed methods are not adequately described.
As set forth above, SEQ ID NO: 4 meets the functional limitations of at least claim 1, part (a), and is adequately described.
As set forth above, SEQ ID NO: 12 meets the functional limitations of claim 1, part (b), and is adequately described.
As set forth above, SEQ ID NO: 16 meets the functional limitations of claim 1, part (c), and is adequately described.
As set forth above, no other second antibody disclosed in the specification meets the functional limitations of the claims.
In the absence of a second antibody meeting the functional limitations of the claims, the claimed methods are not adequately described.
Claims 1, 174, 176-177, and 188-192 recite functional properties for the second antibodies in the absence of any structural properties such as amino acid sequence.
The specification does not provide representative examples for all camelid sdAbs that specifically bind guinea pig IgG, rat/mouse IgG, human IgM, rabbit, goat, and/or rat having the functional attributes of claims 1 (parts (a)-(f)), 174, 176-177, 189 (parts (a)-(c), and 190-192. They do not establish a structure/function correlation sufficient to adequately describe the genus of second antibodies claimed.
Paragraph [0083] of the specification indicates that the antibodies can be generated by methods known in the art, referring for example to Pleiner et al. (2015; 4:e11349, of record). A reference to a general technique for fluorescently labeling nanobodies does not adequately describe the structure of particular camelid sdAbs with particular functional characteristics that are required by the claims. Applicant is reminded that the written description requirement is separate from the enablement requirement. There is no evidence of record that other camelid sdAbs within the scope of the claims would have been known in the prior art.
The structures of the camelid sdAbs claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 111 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 thegenus are described in the patent. With the written description of a genus, however, merelydrawing a fence around a perceived genus is not a description of the genus. One needs to showthat 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 researchplan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598F.3d at 1353 (The written description requirement guards against claims that “merely recite adescription of the problem to be solved while claiming all solutions to it and ... cover anycompound later actually invented and determined to fall within the claim's functionalboundaries.”).
In the instant application, the specification and claims draw a fence around a perceivedgenus of camelid sdAbs but the genus is not adequately described. 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.
Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011)is also applicable to the instant claims. Centocor’s claims were directed to antibodies with nospecific structure and requiring particular functionality. This decision states, “...the specificationmust demonstrate constructive possession, and the '775 patent's specification fails to do so. Ariad, 598 F.3d at 1352. Centocor’s asserted claims to fully-human antibodies ‘merely recite a description of the problem to be solved while claiming all solutions to it.’ Ariad, 598 F.3d at 1353. The actual inventive work of producing a human variable region was left for subsequent inventors to complete.” The instant application fails to demonstrate constructive possession sufficient to support the breadth of the claims.
Applicant’s arguments are unpersuasive. Again, applicant has not invoked 35 USC 112(f) means plus function language.
Applicant admits that prior to the effective filing date camelid sdAbs having the low extent of cross-reactivity as recited in claim 1 were not known in the art. See page 17 of the 6/28/2023 response. While applicant argues that such antibodies exist (see page 18 of the 6/28/2023 response), the specification and the current record do not document a representative number of such camelid sdAbs that would have been known at time of the effective filing date. Only the camelid sdAbs of SEQ ID NOS: 4, 12, and 16 have been demonstrated as meeting the functional limitations of the claims.
Applicant is again reminded that written description and enablement are separate requirements. An argument that one of ordinary skill in the art could make and test for camelid sdAbs having the functional properties of the claims does not meet the standard for adequate written description. Applicant’s response does not address this.
The genus of camelid sdAbs encompassed by the instant claims are not adequately described and thus the claimed methods requiring the camelid sdAbs are not adequately described.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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