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 04/16/26 is acknowledged.
2. Claims 1,3-14,16,24-26,28,30-32,38, 42,43,52,54,55, 57 are pending.
3. Claims 14, 16-,24, 31,32,38,42,43,55,57 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,3-13, 25, 26, 28, 30, 52 and 54 read on an isolated nucleic acid encoding CAR 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 1,3-13, 25, 26, 28, 30, 52 and 54 stand 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 for the same reasons set forth in the previous Office Action mailed on 10/16/25.
Applicant’s arguments filed on 04/16/26 have been fully considered but have not been found convincing.
Applicant asserts that claims 1 and 52 have been amended to recite the presence of 6 CDRs primary responsible for binding.
Contrary to Applicant’s assertion the instantly amended claims are still recited 90% identity to SEQ ID NOs 3 and 5.
The Examiner acknowledged that :
Applicant is in possession of : 1) an isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by SEQ IDN:3, comprising and VL encoded by SEQ IDN:5 and comprising CDR-VH1 of aa 31-35 of SEQ ID NO: 13, CDR-VH2 of aa 50-66 of SEQ IDNO:13 and CDR-VH3 of aa 99-106 of SEQ ID :13 CDR-VL1 of aa24-34 of SEQ ID NO:15, CDR VL-2 of aa 50-56 of SEQ ID :15 and CDR-VL3 of aa 88-97 of SEQ ID NO:15 and wherein transmembrane domain encoded by SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoding by SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by SEQ ID :9.
However, the Examiner reiterated his position that Applicant is not in possession of : any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9.
The claimed invention is drawn to a genus of any isolated nucleic acid encoding CAR, 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 an isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by SEQ IDN:3 and VL encoded by SEQ IDN:5 and wherein transmembrane domain encoded by SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoding by SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by SEQ ID :9 and any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9.
In determining that the Specification did not support the claimed genus of any isolated nucleic acid encoding CAR, the Specification disclosure is considered. The specification fails to disclose a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation between an isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by SEQ IDN:3 and VL encoded by SEQ IDN:5 and wherein transmembrane domain encoded by SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoding by SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by SEQ ID :9 and any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9. Thus the skilled artisan could not envision the detailed chemical structure of the encompassed genus of any isolated nucleic acid encoding any CARs 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.
Given the well known fact that even a single amino acid substitution or what appears to be an inconsequential chemical modification will often dramatically affect the biological activity and characteristic of a protein the skilled artisan would not have been in possession of the vast repertoire of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9
The claims do not define the relevant identifying characteristics, namely the relevant amino acid/nucleic acid sequences of the claimed genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9 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 genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9 but the specification does not identify any disclosure of a correlation between the claimed function and the structure of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9that 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 genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9 encompassing various structures, specificities and functional limitations that retain the appropriate structural and functional attributes encompassed by the claims.
Note that the claims do not recite and the specification does not provide sufficient written description of the structure-identifying of genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9 encompassing various structures, specificities and functional limitations that retains the same function as isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 100 % identical to SEQ IDN:3 and VL encoded by a sequence that is100 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 100 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 100 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 100 % identical to SEQ ID :9. Given the claimed broadly class any isolated nucleic acid encoding CAR and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed genus of genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9 encompassing various structures, specificities and functional limitations encompassed by the claims 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 genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :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 genus of any isolated nucleic acid encoding CAR, wherein said CAR comprising VH encoded by a sequence that is 90 % identical to SEQ IDN:3 and VL encoded by a sequence that is 90 % identical to SEQ IDN:5 and wherein transmembrane domain encoded by a sequence that is 90 % identical to SEQ ID NO7, and wherein integrin alphav betta3 binding domain is attached to transmembrane domain via peptide encoded by a sequence that is 90 % identical to SEQ ID NO:6, and wherein the 4-1 BB signaling domain is encoded by a sequence that is 90 % identical to SEQ ID :9 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.
6. Prior to setting the art rejections it is noted that the term “optionally” recited in claims 6, 8, 9,10 is interpreted as the linker peptide does not encoded by SEQ ID NO:4 , CD28 signaling domain does not encoded by SEQ ID NO:9 and intracellular signaling domain does not encoded by SEQ ID NO: 10 or 2.
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. Claims 1,3-13, 25, 26, 28, 30, 52 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20180265585 in view of US Patent 6590079 and US Patent 11286306 as is evidence from the WO 20202107668 for the same reasons set forth in the previous Office Action, mailed on 10/16/25.
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant asserts that US Patent’ 585 disclosed a CARs comprising a hinge region while the instant claims recited that CAR does not have hinge region.
The Examiner disagrees with Applicant’s interpretation of the teaching of US Patent Application’585. US Patent Application’585 only teaches that CAR of the present invention should have a extracellular domain, transmembrane domain a costimulatory domain and a cytoplasmic domain ( see parargraph 0042 in particular). Nowhere does US Patent Application’585 teaches that hinge region must definitely be present in the structure of claimed CAR.
Moreover, as is evidence from the teaching of WO 2020210768 before the effective filing date of the claimed invention one skill in the art would know that in some instances it is a desirable to remove (not include) a hind region when constructing CAR for immunotherapy. ( see page 55 in particular).
Thus, it is the Examiner’s position that it would be conventional and within the skill of the art to : (i) identify the optimal structure of CAR with or without hinge region for immunotherapy. 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).
As has been stated previously, US Patent Application’585 teaches an isolated nucleic acid encoding CAR, wherein the CAR comprises an integrin alphav beta3 binding domain, a transmembrane domain, comprising CD8 alpha, a cytoplasmic co-stimulatory domain and an intracellular signaling domain, wherein CAR is free of an extracellular immunoglobin G4 hinge domain. US Patent Application’585 teaches a retroviral vector comprising said nucleic acid construct. US Patent Application’585 teaches that said CAR can be used in cellular immunotherapy for treating various diseases , including integrin alphav beta3 related. US Patent Application’585 teaches modified immune cells comprising said an isolated nucleic acid encoding CAR ( see entire document, paragraphs,0015, 0018, 0040, 0033, 0042,0046, 0082 in particular)
US Patent Application’585 does not teach the integrin alphav beta3 binding domain comprises VH that is at least 90% identical to SEQ ID NO:3 and VL is at least 90% identical to SEQ ID NO: 5 or wherein transmembrane domain comprises sequences that is at least 90% identical to SEQ ID NO:7.
US Patent ‘079 teaches an isolated nucleic acid encoding integrin alphav beta3 binding domain comprises VH of SEQ ID NO: 1 that is 100% identical to instantly claimed SEQ ID NO:3 and VL of SEQ ID NO: 3 is at least 100% identical to the instantly claimed SEQ ID NO: 5. US Patent ‘079 teaches that ( see sequence alignment). US Patent ‘079 teaches that said construct can be used for treating integrin alphav beta3 related diseases ( see entire document, paragraphs 3, 5 ,11 and sequence alignment, attached).
US Patent ‘306 teaches an isolated nucleic acid encoding CAR comprising transmembrane domain encoded by SEQ ID NO:38 that is 100% identical to the instantly claimed SEQ ID NO:7
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute integrin alphav beta3 binding domain taught by US Patent Application ‘585 and transmembrane domain with integrin alphav beta3 binding domain taught by US Patent ‘ and with transmembrane domain taught by US Patent ‘306 with a reasonable expectation of success because the prior art suggests that each of said constructs can be used for treating integrin alphav beta3 related diseases.
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
9. No claim is allowed.
10. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
11. 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
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