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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 10/23/25 is acknowledged.
2 Claims 1, 4-8, 10-13,17, 19, 20, 22, 25, 26-28, 30-32,34-36,45 are pending.
3. Applicant’s election without traverse of Group I , claims 1,4-13,17,19,20,22,25,26,34,45 in the reply filed on 06/23/25 is acknowledged.
Claims 27,28,30-32,35,36 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,4-8,10-13,17,19,20,22,25,26,34,45 read on isolated antibody capable of specifically binding to FGFR2b are under consideration in the instant application.
4. 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.
5. Claims 5, 6, 8 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Applicant is in possession of : the antibody comprising SEQ ID NO7 and SEQ ID NO:9
Applicant is not in possession of : the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 for the same reasons set forth in the previous Office Action mailed on 07/23/25.
Applicant’s arguments filed on 10/23/25 have been fully considered but have not been found convincing.
Applicant asserts that claims 5 and 6 have been amended to recited “homologous sequences” with 80% identity outside of the CDRs region.
Contrary to Applicant’s assertion, as has been stated previously, the claimed invention is drawn to a genus of antibody that recognize and specifically binds to FGFR2b and FGFR1b however, structural identifying characteristics of the genus are not disclosed. There is no evidence that there is any per se structure/function relationship between the disclosed antibody comprising SEQ ID NO7 and SEQ ID NO:9 and any others that comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 that specifically binds to FGFR2b and FGFR1b or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6.
The specification does not disclosed any amino acid sequences of claimed antibody comprising SEQ ID NO7 and SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 that specifically binds to FGFR2b and FGFR1b.
In determining that the Specification did not support the claimed the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 the Specification disclosure or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 is considered. The specification fails to disclose a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Two of these factors described in the Specification was "a functional recitation of competing for binding" Thus the skilled artisan could not envision the detailed chemical structure of the encompassed genus of antibodies comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Absent a recitation of distinguishing identifying characteristics, the Specification does not provide adequate written description support of the claimed genus.
A description of a protein by functional language in the absence of a structure is not considered sufficient to show possession of the claimed invention. A description of what a material does rather than of what it is, usually does not suffice. See Fiers, 984 F.2d at 1169-71, 25 USPQ2D at 1605-06. It is only a definition of a useful result rather than a definition of what achieves that result. Many species may achieve that result. The definition 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, 22 USPQ 369, 372-73 (Fed. Cir. 1984) affirming the rejection because the specification does “little more than outline[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 the material consists of (e.g. structural feature), is not a description of that material.
Given the well known high level of polymorphism of immunoglobulins / antibodies, the skilled artisan would not have been in possession of the vast repertoire of antibodies and the unlimited number of antibodies encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of an : the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 encompassing various structures, specificities and functional limitations, broadly encompassed by the claimed invention.
With regards to Applicant’s statement that “amended to recited “homologous sequences” with 80% identity outside of the CDRs region”
Given the well known fact that even a single amino acid substitution or what appears to be an inconsequential chemical modification or will often dramatically affect the biological activity and characteristic of a protein the skilled artisan would not have been in possession of the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 and capable of specifically binding to both FGFR2b and FGFR1b broadly encompassed by the claimed invention.
The claims do not define the relevant identifying characteristics, namely the relevant amino acid sequences of the claimed genus of : the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 encompassing various structures, specificities and functional limitations.
On 22 February 2018, the USPTO provided a Memorandum clarifying the Written Description Guidelines for claims drawn to antibodies, which can be found at www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf. That Memorandum indicates that, in compliance with recent legal decisions, the disclosure of a fully characterized antigen no longer is sufficient written description of an antibody to that antigen. Accordingly, the instant claims have been re-evaluated in view of that guidance.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, 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 claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.”
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483.
The Federal Circuit has recognized that "the written description requirement can in some cases be satisfied by functional description," it has made clear that "such functional description can be sufficient only if there is also a structure-function relationship known to those of ordinary skill in the art." In re Wallach, 378 F.3d 1330, 1335 (Fed. Cir. 2004); see also, Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (holding that the written description requirement would be satisfied "if the functional characteristic of preferential binding ... were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed"); Amgen Inc. v. Sanofi, 782 F.3d 1367, 1378 (Fed. Cir. 2017) (holding that an "adequate written description must contain enough information about the actual makeup of the claimed products"). Here, the specification provides a functional description of the claimed antibody- i.e., that it competes for binding an anti-CD3 immune molecule / anti-CD3 antibodrecited in the claim, but the specification does not identify any disclosure of a correlation between the claimed function and the structure of the antibodies that perform that function.
Federal Circuit clarification of the law of written description as it applies to antibodies. The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.
Also, it is noted that the Court has held that the disclosure of screening assays and generalclasses of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Here, the problem here is that the instant specification fails to provide a disclosure of which amino acids are required for the claimed genus of the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 encompassing various structures, specificities and functional limitations that retain the appropriate structural and functional attributes encompassed by the claimed methods.
Given the claimed broadly class of antibodies and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed genus of the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 encompassing various structures, specificities and functional limitations encompassed by the claimed methods, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims.
AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014)
And the specification at best describes plan for making a genus of the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 encompassing various structures, specificities and functional limitations
then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient.
Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011).
Therefore, there is insufficient written description for the genus of the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 encompassing various structures, specificities and functional limitations by the claimed methods to provide sufficient structure for the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 or any antibody comprising any amino acid substitution or modification in SEQ ID Nos 1-6 encompassing various structures, specificities and functional limitations claimed at the time the invention was made and as disclosed in the specification as filed under the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant 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.)
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property.
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
Ariad points out, the written description requirement also ensures that when a patent claims
a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018.
See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
The Memo clarifies the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) concerning the written description requirement for claims drawn to antibodies, including the following.
“In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional”.
“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.” See Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
“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.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
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 is “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).
This it is the Examiner’s position that one of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus of : the antibody comprising Vh having 80% sequence identity to SEQ ID NO7 and 80% sequence identity to SEQ ID NO:9 that can specifically binds to FGFR2B and FGFR1b.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claim(s) 1, 8, 10-13,17,19,20, 22, 25, 34, 45 stand rejected under 35 U.S.C. 102(a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Patents 8062635, 7531648, 9309306; 7,371825 for the same reasons set forth in the previous Office Action mailed on 07/23/25.
Applicant’s arguments filed on 10/23/25 have been fully considered but have not been found convincing.
Applicant asserts that as amended the claims now recited that antibody comprises all six of CDR sequences.
Contrary to Applicant’s assertion it is noted that an amended claims do not recited that antibody comprises all 6 CDR sequence but rather that antibody comprising sequence selected from the group of SEQ IDs 1-6. ( emphases added)
As has been stated previously, US Patent’635 teaches an isolated antibody, comprising CDR of SEQ IDN:14 that is 100% identical to the instantly claimed CDR of SEQ ID N:1 ( see sequence alignment).
US Patent’648 teaches an isolated antibody, comprising CDR of SEQ IDN:26 that is 100% identical to the instantly claimed CDR of SEQ ID N:2 ( see sequence alignment).
US Patent’306 teaches an isolated antibody, comprising CDR of SEQ IDN:15 that is 100% identical to the instantly claimed CDR of SEQ ID N:3 ( see sequence alignment).
US Patent’825 teaches an isolated antibody, comprising CDR of SEQ IDN:5 that is 100% identical to the instantly claimed CDR of SEQ ID N:4 ( see sequence alignment).
It is noted that US Patents 8062635, 7531648,9, 309306; 7,371825 do not explicitly teach that the claimed antibody specifically binds to FGFR2b and FGFR1b. However said functional properties would be inherent properties of the referenced because the reference antibody comprising CDRs that are 100% identical to the instantly claimed. Since the office does not have a laboratory to test the reference antibodies, it is applicant’s burden to show that the reference antibodies do not specifically binds to FGFR2b and FGFR1b as recited in the claims. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
A recitation of functional properties if the claimed antibody (specifically binds to FGFR2b and FGFR1b) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. For example in Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999); the following was noted. “Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. “ The Court further held that “this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art”. See MPEP 2112.02. Also, see Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 58 USPQ2d 1508 (CA FC 2001); Ex parte Novitski 26 USPQ 1389 (BPAI 1993); Mehl/Biophile International Corp. V. Milgraum, 52 USPQ2d 1303 (Fed. Cir. 1999); Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999).
Claims 8-13,17,19,20, 22, 25, are included because it would be conventional and within the skill of the art to : (i) identify the specific amino acid substitution or modification; (ii) immunoglobulin constant region (iii) type of conjudate moieties to be linked to said antibody. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
The reference teaching anticipates or , the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
9. 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.
10. Claims 1,4-13,17,19,20,22,25,26,34,45 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. 17/788,729. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application No. 17/788,729 recited an isolated antibody capable of specifically binding to FGFR2b and FGFR1b.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
The following new ground of rejection is necessitated by the amendment filed on 10/23/25
11. The following is a quotation of the first paragraph of 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.
12. Claims 5,6 and 8 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
“ wherein the homologouse sequence has substitution, insertion or deletions occur in the region outside of the CDRs” claimed in 5,6 and 8 represent a departure from the specification and the claims as originally filed .
It is noted that Applicant pointed to paragraph 0093 for the support for said amendment.
Contrary to Applicant’s assertion it is noted that paragraph 0093 explicitly teaches that
“In certain embodiments, the antiFGFR2b antibodies provided herein comprises one or more amino acid residue substitutions in one or more CDR sequences, and/or one or more FR sequences within SEQ ID NOs: 1-6 In certain embodiments, no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 substitutions are made to the CDR sequences and/or FR sequences in total.”
The skill in the art would know that FR region refers to the amino acid sequence of antibody’s framework regions within VH and VL chains.
13. No claim is allowed.
14. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 extension fee 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.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644