DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-4, 9, 12-13, 16, 18-20; species: PR001166; specific heavy chain VH-CDR1, VHCDR2, and VH-CDR3 as set forth in SEQ ID NOs: 23, 59 and 100, and specific light chain VLCDR1, VL-CDR2, and VL-CDR3 as set forth in SEQ ID NOs: 131, 153 and 184) in the reply filed on 4/8/2026 is acknowledged. The traversal is on the grounds that no prior art has disclosed or hinted this elected antibody, and therefore, the Applicant deems that Groups I-IX share a special technical feature and all claims are generic.
However, contrary to Applicant’s arguments, the special technical feature defining the invention is an antibody of specific 6 CDRs. Due to the number of possible material alternatives designated as the antibodies, significant structural similarities cannot readily be ascertained between the antibodies. Without significant structural similarities, the antibodies do not have a
shared special technical feature. In the absence of a shared special technical feature, the
inventions lack unity with one another.
The test for propriety of restriction is not whether the inventions are related but rather whether they are distinct and whether it would impose a burden on the examiner to search and examine multiple inventions in a single invention. The claimed inventions in groups I-IX are independent and distinct, each from the other, requiring separate searches, which would be unduly burdensome. Furthermore, separate search terms would be required for searching the literature, e.g. a search of the literature for a method of treatment would not necessarily reveal art for an association of the method of detection.
The Groups as delineated in the restriction requirement of 2/11/2026 are patentably distinct one from the other such that each invention could, by itself, in principle, support its own separate patent (as shown by the arguments put forth in the written restriction requirement).
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-8, 10-11, 14-15, and 17 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Amended claims 1-2, 13, 16, 19-20, (4/8/26), and previously presented claims 3-4, 9, 12, 18, are under consideration by the Examiner.
Information Disclosure Statement:
The information disclosure statements filed on 6/30/2023, and 8/13/2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim Rejections - 35 USC 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4a. Claims 16 and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 16, line 1, is rejected under 35 U.S.C. 101 because of the recitation of “use”. The claim embraces “use” of the antibody and there are no provisions for "use" in the statutes. In view of the improper format for claim 18, this claim will be examined for a reasonable interpretation of its intended meaning. Appropriate correction of claim 16 is requested to obviate this rejection.
Similarly, claim 18, line 1, is rejected under 35 U.S.C. 101 because of the recitation of “use”. Appropriate correction of claim 18 is requested to obviate this rejection.
Similarly, claim 19, line 6, is rejected under 35 U.S.C. 101 because of the recitation of “use”. Appropriate correction of claim 19 is requested to obviate this rejection.
Claim Rejections - 35 USC § 112, first paragraph, written description
5. 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.
5a. Claims 1-4, 9, 12-13, 16, 18-20, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has claimed an antibody or an antigen-binding fragment against Trop-2 comprising complementarity determining regions (CDRs) as follows: (a) an HCDR1 or a variant of a sequence thereof, an HCDR2 or a variant of a sequence thereof, and an HCDR3 or a variant of a sequence thereof comprised in a heavy chain variable region (VH) set forth in SEQ ID NO: 217; and (a) an LCDR1 or a variant of a sequence thereof, an LCDR2 or a variant of a sequence thereof, and an LCDR3 or a variant of a sequence thereof comprised in a light chain variable region (VL) set forth in SEQ ID NOs: 238; preferably, the variant of the sequence is a CDR having one or several amino acid substitutions, deletions, or additions compared to a CDR from which the variant is derived; preferably, the substitutions are conservative substitutions.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. § 112(a), "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, January 5, 2001, see especially page 1106 column 3).
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted.
To show invention, a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
In The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F. 3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the court also noted: “A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin [e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.”
The court has further stated that “Adequate written description 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.” Id. at 1566, 43 USPQ2d at 1404 (quoting Fiers. 984 F.2d at 1171, 25 USPQ2d at 1606). Also see Enzo-Biochem v. Gen-Probe 01-1230 (CAFC 2002).
As discussed above, Applicant has claimed in claim 1 a Trop-2 antibody comprising complementarity determining regions (CDRs) as follows: (a) an HCDR1 or a variant of a sequence thereof, an HCDR2 or a variant of a sequence thereof, and an HCDR3 or a variant of a sequence thereof comprised in a heavy chain variable region (VH) set forth in SEQ ID NO: 217; and (a) an LCDR1 or a variant of a sequence thereof, an LCDR2 or a variant of a sequence thereof, and an LCDR3 or a variant of a sequence thereof comprised in a light chain variable region (VL) set forth in SEQ ID NOs: 238; preferably, the variant of the sequence is a CDR having one or several amino acid substitutions, deletions, or additions compared to a CDR from which the variant is derived; preferably, the substitutions are conservative substitutions.
Claim 2 recites that the antibody or the antigen-binding fragment has heavy chain VH-CDR1, VH-CDR2, and VH-CDR3 as set forth in SEQ ID NOs: 23, 59 and 100, and light chain VL-CDR1, VL-CDR2, and VL-CDR3 as set forth in SEQ ID NOs: 131, 153 and 184, wherein, any one of the amino acid sequences described above further comprises a derived sequence optionally subjected to addition, deletion, modification, and/or substitution of at least one amino acid and capable of retaining the binding affinity for TROP2.
Claim 12 recites a multispecific antibody comprising the antibody or the antigen- binding fragment against Trop-2 according to claim 1, and an additional antibody or a fragment or an antibody analog thereof; preferably, the multispecific antibody is bispecific, trispecific, or tetraspecific.
Recent court cases have indicated that recitation of an antibody which has specific functional properties in the absence of knowledge of the antibody sequences that give rise to said functional properties do not satisfy the requirements for written description. See for example AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) as well as Amgen v. Sanofi. (Fed Cir, 2017-1480. 10/5/2017). Indeed, in Amgen the court indicates that that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e. the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it. Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
In the instant case, the specification discloses on page 32, lines 2-15, discloses:
“Furthermore, in another embodiment, the present invention provides an isolated Trop2 monoclonal antibody or an antigen-binding moiety thereof, which comprises a heavy chain variable region and a light chain variable region comprising: (a) a VH CDR1 region comprising the sequence of the present invention, or an amino acid sequence with one, two, three, four, or five amino acid substitutions, deletions, or additions; (b) a VH CDR2 region comprising the sequence of the present invention, or an amino acid sequence with one, two, three, four, or five amino acid substitutions, deletions, or additions; (c) a VH CDR3 region comprising the sequence of the present invention, or an amino acid sequence with one, two, three, four, or five amino acid substitutions, deletions, or additions; (d) a VL CDR1 region comprising the sequence of the present invention, or an amino acid sequence with one, two, three, four, or five amino acid substitutions, deletions, or additions; (e) a VL CDR2 region comprising the sequence of the present invention, or an amino acid sequence with one, two, three, four, or five amino acid substitutions, deletions, or additions; and (f) a VL CDR3 region comprising the sequence of the present invention, or an amino acid sequence with one, two, three, four, or five amino acid substitutions, deletions, or additions.”
Therefore, Applicants claims encompass “variants” comprising one, two, three, four, or five amino acid substitutions, deletions, or additions in the heavy and light chain CDRs.
Applicant is reminded that the courts have long ruled that “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” See University of Rochester. 358 F.3d at 927, 69 USPQ2d at 1895. As such, disclosure of a screening assay to test for functional properties of an antibody does not provide evidence of possession of the antibody itself.
It is well established in the art that the formation of an intact antigen-binding site requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three different complementarity determining regions, CDR1, CDR2 and CDR3, which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of the heavy chain CDRs and the light chain CDRs are critical in maintaining the antigen binding specificity and affinity. It is also known that single amino acid changes in the CDRs can abrogate the antigen binding function of an antibody (Rudikoff et al., 1982, see entire document, particularly the abstract and the middle of the left column of page 1982). However, as discussed above, only the 6 CDRs for the antibody or the antigen-binding fragment having a heavy chain VH-CDR1, VH-CDR2, and VH-CDR3 as set forth in SEQ ID NOs: 23, 59 and 100, and light chain VL-CDR1, VL-CDR2, and VL-CDR3 as set forth in SEQ ID NOs: 131, 153 and 184, and a heavy chain variable region (VH) set forth in SEQ ID NO: 217; and a light chain variable region (VL) set forth in SEQ ID NOs: 238 have been described (See PR001166 in Tables 1a and 1b on pages 26-27).
Indeed, in AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) the court ruled that all of the antibodies disclosed by AbbVie were all structurally similar as they were variants of a starting antibody named Joe9 and therefore did not serve to inform artisans as to the breadth of structures which had the recited function of cytokine binding. In the instant application, the instant claims recite antibodies to be used in the claimed methods while the specification does not disclose structures which necessarily have the requisite functions. The instant specification fails to disclose sufficient structural information to indicate to artisans that Applicant had possession of the various antibodies as presently claimed. Therefore, it appears that the broad genus of antibodies recited in Applicant’s claims lacks adequate written description because there does not appear to be sufficient correlation between the structure of the antibodies in question and their recited functional activities. As such a skilled artisan would reasonably conclude that Applicant was not in possession of the recited genus of antibodies. Therefore, there is insufficient written description for genus of antigen-binding immunoglobulin molecules having the claimed “limitations” at the time the invention was made and as disclosed in the specification as filed under the written description provision of 35 USC 112.
Appellant has been reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115.)
Claim rejections-35 USC § 112, second paragraph
6. 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.
6a. Claims 1-4, 9, 12-13, 16, 18-20 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 pre-AIA the applicant regards as the invention.
Claim 1 is rejected as vague and indefinite for several reasons.
Claim 1 is vague and indefinite because it recites the limitation "variant" in lines 3, 4, 6, 7, 9, and 10. The metes and bounds of the term are unclear. How different is the “variant” from the original Trop-2 monoclonal antibody? Is it 50%, 75% or 99% similar?
Regarding claim 1, lines 9-10, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction of claim 1 is requested to obviate this rejection.
Claim 1, line 9, is rejected as vague and indefinite because it recites “having one or several amino acid substitutions, deletions, or additions compared to a CDR from which the variant is derived”. Firstly, there is no upper limit on the number of amino acid substitutions, deletions, or additions compared to the original CDR. Secondly, the term “derived” is itself vague and indefinite because it is unclear how similar the CDR is to the original Trop-2 monoclonal antibody CDRs? Is it 50%, 75% or 99% similar? Therefore, the metes and bounds of the claim are unclear. Appropriate amendment of claim 1 is requested to obviate this rejection.
Claim 2 is rejected as vague and indefinite for several reasons.
Claim 2, line 3, is improper because it recites the limitation "has heavy chain " rather than the conventional “comprises heavy chain”.
Claim 2 is rejected as vague and indefinite because it recites “….wherein, any one of the amino acid sequences described above further comprises a derived sequence optionally subjected to addition, deletion, modification, and/or substitution of at least one amino acid and capable of retaining the binding affinity for TROP2”. Firstly, there is no upper limit on the number of amino acid substitutions, deletions, or additions compared to the original CDR recited in the claim. Secondly, the term “derived” is itself vague and indefinite because it is unclear how similar the CDR is to the original Trop-2 monoclonal antibody CDRs? Is it 50%, 75% or 99% similar? Therefore, the metes and bounds of the claim are unclear. Appropriate amendment of claim 2 is requested to obviate this rejection.
Claim 4, line 1, is rejected as vague and indefinite because it recites “ a recombinant protein”, is redundant because the only protein recited in the specification is the antibody to Trop-2. It is required that the claim be amended to recite “an antibody….and an optional tag…”.
Claim 12 is rejected as vague and indefinite for several reasons.
Claim 12, line 3, is vague and indefinite because it recites the limitation "antibody analog”. Firstly, there is no upper limit on the number of amino acid substitutions, deletions, or additions compared to the original Trop-2 antibody recited in the claim. Secondly, it is unclear how similar the CDR’s in this antibody are to the original Trop-2 monoclonal antibody CDRs? Is it 50%, 75% or 99% similar? Therefore, the metes and bounds of the claim are unclear. Appropriate correction of claim 12 is requested to obviate this rejection.
Regarding claim 12, line 3, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction of claim 12 is requested to obviate this rejection.
Claim 13 is rejected as vague and indefinite for several reasons.
Claim 13 is vague and indefinite because it recites non-elected subject matter. “An immune cell” is not elected subject matter. Appropriate correction of claim 13 is requested to obviate this rejection.
Claim 13 is rejected as vague and indefinite because the pharmaceutical composition recites “the recombinant protein comprising the antibody or the antigen- binding fragment, the antibody-drug conjugate comprising the antibody or the antigen-binding fragment, an immune cell expressing the antibody or the antigen-binding fragment, the multispecific antibody comprising the antibody or the antigen-binding fragment, and combinations thereof”. However, it is unclear what “anti-drug conjugate” or “multispecific antibody” is being referred to in the claim because these limitations are not dependent on claim 1. It is required that a pharmaceutical composition comprising the “anti-drug conjugate” and “multispecific antibody” be recited as separate claims dependent on claim 9 and claim 12, respectively.
Claim 13 is vague and indefinite because it recites “combinations thereof” and it is inconceivable that all these active ingredients recited in the claim can be in a single pharmaceutical composition.
Similarly, claim 16 is vague and indefinite because it recites non-elected subject matter. “An immune cell” is not elected subject matter. Appropriate correction of claim 16 is requested to obviate this rejection.
Claim 16 is rejected as vague and indefinite because it recites “the recombinant protein comprising the antibody or the antigen- binding fragment, the antibody-drug conjugate comprising the antibody or the antigen-binding fragment, an immune cell expressing the antibody or the antigen-binding fragment, the multispecific antibody comprising the antibody or the antigen-binding fragment, and/or the pharmaceutical composition comprising the antibody or the antigen-binding fragment, in preparing a medicament for the prevention and/or treatment of a tumor, wherein the tumor is breast cancer, gastric cancer, pancreatic cancer, ovarian cancer, intestinal cancer, lung cancer, cervical cancer, or other tumor positive for Trop2 expression”. Firstly, it is unclear what “anti-drug conjugate” or “multispecific antibody” is being referred to in the claim because these limitations are not dependent on claim 1.
Secondly, claim 16 is a mixed claim and is rejected as vague and indefinite because it recites “for the prevention and/or treatment of a tumor, wherein the tumor is breast cancer, gastric cancer, pancreatic cancer, ovarian cancer, intestinal cancer, lung cancer, cervical cancer, or other tumor positive for Trop2 expression”. Claim 16 is a product claim and there is improper recitation of a product and treatment using the product recited in the claim. The claim is confusing because it is unclear how the intended use further limits the product. The expression “for the prevention and/or treatment” does not change the nature of a composition. It is required that the claim be amended to delete the intended use, to obviate this rejection.
Claim 18 is rejected as vague and indefinite because it recites “use….in preparing a detection reagent or kit” because this is a product claim and Applicant is reciting both a method and a product in the same claim. It is required that the claim be amended to delete the intended use, to obviate this rejection.
Claim 19 is vague and indefinite for several reasons.
Claim 19 is vague and indefinite because it recites non-elected subject matter. “An immune cell” is not elected subject matter. Appropriate correction of claim 19 is requested to obviate this rejection.
Claim 19 is rejected as vague and indefinite because it recites “….the recombinant protein comprising the antibody or the antigen- binding fragment, the antibody-drug conjugate comprising the antibody or the antigen-binding fragment, an immune cell expressing the antibody or the antigen-binding fragment, the multispecific antibody comprising the antibody or the antigen-binding fragment, and/or the pharmaceutical composition comprising the antibody or the antigen-binding fragment, and optionally instructions for use”. Firstly, it is unclear what “anti-drug conjugate”, “multispecific antibody” or “pharmaceutical composition” is being referred to in the claim because these limitations are not dependent on claim 1. It is required that kit claims comprising the “anti-drug conjugate” “multispecific antibody” and “pharmaceutical composition” be recited as separate claims depending on claim 9, claim 12, and claim 13, respectively.
Claim 20 is vague and indefinite for several reasons.
Claim 20 is vague and indefinite because it recites non-elected subject matter. “An immune cell” is not elected subject matter. Appropriate correction of claim 20 is requested to obviate this rejection.
Claim 20 is rejected as vague and indefinite because it recites “an administration device comprising: (i) an infusion module for administering to a subject a pharmaceutical composition comprising an active ingredient; (ii) a pharmaceutical composition for infusion, comprising an active ingredient selected from the group consisting of: the antibody or the antigen-binding fragment according to claim 1, the recombinant protein comprising the antibody or the antigen-binding fragment, the antibody-drug conjugate comprising the antibody or the antigen-binding fragment, an immune cell expressing the antibody or the antigen-binding fragment, the multispecific antibody comprising the antibody or the antigen-binding fragment, and/or the pharmaceutical composition comprising the antibody or the antigen-binding fragment; and (iii) an optional pharmacodynamic monitoring module”.
Firstly, it is unclear what “anti-drug conjugate”, “multispecific antibody” or “pharmaceutical composition” is being referred to in the claim because these limitations are not dependent on claim 1. It is required that device claims comprising the “anti-drug conjugate” “multispecific antibody” or “pharmaceutical composition” be recited as separate claims depending on claim 9, claim 12, and claim 13, respectively.
Claims 3, 9, are rejected because they are dependent on claim 1 for its limitations.
Conclusion
No claim is allowable.
Claims 1-4, 9, 12-13, 16, and 18-20 are rejected
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Prema Mertz whose telephone number is (571) 272-0876. The examiner can normally be reached on Monday-Friday from 7:00AM to 3:30PM (Eastern time).
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1646
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