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 .
Claims 2, 5-173, 175, and 178-188 have been cancelled.
Claims 1, 3-4, 174, 176-177, and 189-192 are under consideration.
Applicant's arguments filed 7/7/2026 have been fully considered but they are not persuasive.
Applicant is requested to provide the 7/17/2026 decision revoking EP 3 596 464 after appeal (Appeal No. T0124/24) in order to complete the instant record.
Claim Objections
Applicant is advised that should claims 1, 174, 176, and 177 be found allowable, claims 189-192, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
As amended, claims 1 and 189 recite the same limitations. They are duplicate claims. Claims 190-192 each depend on claim 189 and recite the same limitations as claims 174, 176, and 177 which each depend on claim 1. Claims 190-192 are duplicates of claims 174, 176, and 177, respectively.
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 189-192 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 limitations “means for detecting,” “means for binding,” and “means for producing a fluorescent signal” invoke 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 functions and to clearly link the structure, material, or acts to the function. Therefore, independent claims 1 and 189 and dependent claims 3-4, 174, 176-177, and 190-192 are indefinite and are rejected 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.
35 U.S.C. 112(f) states that a claim limitation expressed in means plus function language “shall be construed to cover the corresponding structure…described in the specification and equivalents thereof.” The language “the corresponding structure” (underlying added) implies one structure. “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. Claims 1 and 189 require three separate means: the “means for detecting,” the “means for binding,” and the “means for producing a fluorescent signal.” There are no specific corresponding structures disclosed in the specification for the “means for detecting,” the “means for binding,” and the “means for producing a fluorescent signal.” The specification does not disclose corresponding structures for the “means for detecting” comprising the “means for binding” and the “means for producing a fluorescent signal.” Note that the claims do not set forth how the “means for binding” and the “means for producing a fluorescent signal” (particularly any equivalents) are combined or associated to result in the “means for detecting.” It is noted that adding limitations such as fusing or attaching etc. would likely result in claims that do not properly invoke 35 USC 112(f).
Applicant’s response does not clearly link or associate SEQ ID NOS: 4, 12, and 16 to the function of detecting any first antibody. The specification indicates that SEQ ID NOS: 4, 12, and 16 are exemplary (see specification paragraphs [0079-0081] Applicant’s response does not identify a specifically disclosed “means for detecting” such that one would be advised of the equivalents permitted by 35 USC 112(f).
Note that claims 1 and 189 encompass three structurally and functionally different “means for binding” (and by extension three structurally and functionally different “means for detection” as the “means for detection” comprises the “means for binding”). The “means for binding” in claim 1, part (a); claim 1, part (b); and claim 1, part (c), CANNOT be the same “means for binding” as they require three different binding specificities as recited in the claim. That is, the “means for binding” for part (a) is NOT a corresponding structure for part (b) or part (c). See also claim 189.
Applicant’s 7/7/2026 response points to the camelid sdAb of SEQ ID NO: 4 as a disclosed “means for binding” for part (a) of claims 1 and 189. The response points to the camelid sdAb of SEQ ID NO: 12 as a disclosed “means for binding” for part (b) of claims 1 and 189. The response points to the camelid sdAb of SEQ ID NO: 16 as a disclosed “means for binding” for part (c) of claims 1 and 189.
SEQ ID NO: 4 is NOT a corresponding structure for SEQ ID NO: 12 or SEQ ID NO: 16. No corresponding structures for SEQ ID NO: 4 and having the required binding characteristics are disclosed.
SEQ ID NO: 12 is NOT a corresponding structure for SEQ ID NO: 4 or SEQ ID NO: 16. No corresponding structures for SEQ ID NO: 12 and having the required binding characteristics are disclosed.
SEQ ID NO: 16 is NOT a corresponding structure for SEQ ID NO: 4 or SEQ ID NO: 12. No corresponding structures for SEQ ID NO: 16 and having the required binding characteristics are disclosed.
It is further noted that the 7/7/2026 amendment changes the binding characteristics recited in parts (a)-(c) of claims 1 and 189. At least for example, donkey IgG, pig IgG, and horse IgG are no longer recited in parts (a)-(c). At least for example, human IgM is no longer recited in parts (a)-(b). Note that SEQ ID NOS: 4, 12, and 16 are disclosed as lacking these cross-reactivities; however, the claims now include other means for binding where they may cross-react with donkey IgG, pig IgG, and horse IgG and/or human IgM. See specification paragraphs [0111] at pages 36-37. That is, it is unknown if the equivalents may or may not include cross-reactivities not possessed by SEQ ID NOS: 4, 12, and/or 16.
The 7/7/2026 response asserts that the corresponding structure for the recited "means for producing a fluorescent signal" includes the fluorescent labels (enumerated fluorescent dyes) disclosed at paragraph [0074] as well as the fluorescent protein tags disclosed at paragraph [0071]. These are distinctly different structures and not a single corresponding structure. This is particularly true for the embodiments where cysteines must be introduced or added to the sdAb for attachment of the fluorescent label. Note that the fluorescent protein tag would be expressed as part of a larger protein such as a camelid single domain antibody fusion protein thereby overlapping the definition for the “means for binding.” This makes the definitions of “means for producing a fluorescent signal” and “means for binding” ambiguous. This does not clearly link or associate a single corresponding structure with the required function.
The claims are also indefinite as while they recite a “means for producing a fluorescent signal,” the method does not have any step whereby a fluorescent signal is produced such that it can be detected. As stated in applicant’s 7/7/2026 response “means for producing a fluorescent signal” recites a function, namely the capacity to emit light upon excitation. At least for example, there is no step for excitation where external light that is absorbed is then emitted (i.e. fluoresces). Applicant is reminded about the distinction between chemiluminescence (emits light from a chemical reaction without external excitation) and fluorescence.
The corresponding structures for the three means are not disclosed to inform one of ordinary skill in the art what is intended for these means and by extension their equivalents. The originally filed specification and claims did not disclose means plus function language according to 35 USC 112(f). At least for example, there is no disclosure in the original specification or claims that “equivalents” to SEQ ID NOS: 4, 12, and 16 were part of the invention.
Applicant’s arguments with respect to Ex parte Chamberlain, Appeal 2022-001944 (Appeal Review Panel of the PTAB, May 21, 2024), a decision issued by an Appeal Review Panel comprising the Director of the USPTO, the Commissioner for Patents, and the Chief Administrative Patent Judge, which was formed in response to the remand in In re Xencor, Inc., No. 2023-2048 (Fed. Cir. Jan. 23, 2024) are not persuasive. Ex parte Chamberlain and In re: Xencor, Inc. (2024-1870, decided 13 March 2025) are not precedential decisions and the fact pattern in the 16/803,690 application can be distinguished from the fact pattern in the instant application. Claim 9 of the 16/803,690 application was directed to (bolding added):
A method of treating a patient by administering an anti-C5 antibody comprising: a) means for binding human C5 protein; and b) an Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of in Kabat et al., wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.
A single means for binding a particular protein as in the ‘690 application can be distinguished from the instant claims having three separate means, where the “means for detecting” comprises two other means, and where the “means for binding” includes three separate means as discussed above. A further distinction is that each “means for binding” in the instant claims has complex binding requirements. The means for binding in part (a) of claims 1 and 189 must specifically bind guinea pig IgG and not be cross-reactive to the following antibody species: mouse IgG, rat IgG, chicken IgY, rabbit IgG, human IgG, goat IgG, and cattle IgG. The means for binding in part (b) of claims 1 and 189 must specifically bind mouse or rat IgG and not be cross-reactive to the following antibody species: guinea pig IgG, chicken IgY, rabbit IgG, human IgG, goat IgG, and cattle IgG. The means for binding in part (c) of claims 1 and 189 must specifically bind human IgM and not be cross-reactive to the following antibody species: guinea pig IgG, mouse IgG, rat IgG, chicken IgY, rabbit IgG, goat IgG, and cattle IgG.
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.).
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).
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.
Applicant has now invoked 35 USC 112(f) means plus function language’ however, they have not adequately described the corresponding structure for the “means for detecting,” the “means for binding,” and the “means for producing a fluorescent signal.”
While the claims have been amended to remove recitations to camelid single domain antibodies, the claims still encompass these embodiments as a “means for binding,” particularly as applicant has pointed out SEQ ID NOS: 4, 12, and 16 in their 7/7/2026 arguments.
SEQ ID NO: 4 meets the functional limitations of part (a) of claims 1 and 189, and is adequately described.
SEQ ID NO: 12 meets the functional limitations of part (b) of claims 1 and 189, and is adequately described.
SEQ ID NO: 16 meets the functional limitations of part (c) of claims 1 and 189, and is adequately described.
The specification indicates that SEQ ID NOS: 4, 12, and 16 are exemplary (see specification paragraphs [0089-0091] but does not disclose the structure of any other “means for binding” having the recited functional characteristics.
The 7/7/2026 amendment changes the binding characteristics recited in parts (a)-(c) of claims 1 and 189. At least for example, donkey IgG, pig IgG, and horse IgG are no longer recited in parts (a)-(c). At least for example, human IgM is no longer recited in parts (a)-(b). Applicant did not point to basis for removal of these cross-reactivities. Note that SEQ ID NOS: 4, 12, and 16 are disclosed as lacking these cross-reactivities; however, the claims now include other means for binding where they may cross-react with donkey IgG, pig IgG, and horse IgG and/or human IgM. See specification paragraphs [0111] at pages 36-37. The amendments to claims 1 and 189 broaden the scope of the claims and no basis is seen for this. The claims constitute new matter.
No “means for detecting” a first antibody comprising a means for binding said first antibody and a means for producing a fluorescent signal has been specifically identified or disclosed in the specification or in applicant’s arguments.
In the absence of the “means for detecting” meeting the limitations of the claims, the claimed methods are not adequately described.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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