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 .
2. Applicant’s amendment filed on 03/28/2025 is acknowledged.
3. Claims 1, 3, 5, 8, 11-12, 16, 18, 20, 22, 25, 31, 33-34, 38, 46, 49, 52, 56-64, 66-67, 71, 77, 85, 99, 102-103, 105-107 and 121-126 are pending.
4. Applicant’s election of the specifies of melanoma, pembrolizumab, vcMMAE, the antibody of SEQ ID NOs 1 and 2, effector function deficient antibody, lyophilization of an aqueous solution with histidine, mannitol, and sucrose and the dosing procedure of .4-1.4 mg/kg once a week for 3 consecutive weeks followed by resting one week in the reply filed on 06/14/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
5. Claims 20, 56-58, 122-123 and 125 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/14/2024. Newly added claims 122-123 and 125 and newly amended claim 20 are included in the withdrawn claims.
6. Claims 1, 3, 5, 8, 11-12, 16, 18, 22, 25, 31, 33-34, 38, 46, 49, 52, 59-64, 66-67, 71, 77, 85, 99, 102-103, 105-107, 121, 124 and 126 are under consideration as they read on the elected species.
7. The following rejections are necessitated by the amendment filed on 03/28/2025.
8. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1, 3, 5, 8, 11-12, 16, 18, 22, 25, 31, 33-34, 38, 46, 49, 52, 59-64, 66-67, 71, 77, 85, 99, 102-103, 105-107, 121, 124 and 126 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10-11, 13-14, 16, 21, 24-25, 30, 32-33, 35-38, 41, 44, 47-50, 52, 54, 57-60, 64, 66-68 and 78 of copending Application No. 17/957,302 (reference application) as evidenced by Rizzetto et al. (PTO-892 mailed on 09/30/2024; Reference U) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 17/957,302 are directed to methods which are encompassed by the instant claims.
Rizzetto et al. is being used as an evidentiary reference to teach that the programmed death (PD-1) inhibitor pembrolizumab was shown to increase survival in metastatic patients. In three clinical trials in patients with advanced melanoma, therapy with pembrolizumab alone resulted in a 30–40% complete clinical response. Specifically, in a study on advanced melanoma, pembrolizumab monotherapy resulted in a 3-year overall survival (OS) of 41% in patients previously treated with ipilimumab and 45% in therapy-naïve patients.
All melanoma patients are at risk of becoming resistant to or failing to respond to pembrolizumab. The claims do not require that pembrolizumab is administered.
The reference teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully requests that this rejection be held in abeyance until the claims of the present application are indicated as being otherwise allowable.”
It is the Examiner’s position that the rejection stands for reasons of record.
10. 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.
11. Claims 1, 3, 5, 8, 11-12, 16, 18, 22, 25, 31, 33-34, 38, 46, 49, 52, 59-64, 66-67, 71, 77, 85, 99, 102-103, 105-107, 121, 124 and 126 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, does not reasonably provide enablement for:
The specification is not enabled for the broad genus of anti-“AXL” antibodies and ADC. The specification has described 9 anti-AXL antibodies as well as 3 variants of these antibodies, but this does not adequately support the broad scope of the recited antibodies and immunoconjugates.
The specification is not enabled for the genus of ADCs comprising antibodies and cytotoxic agents, chemotherapeutic drugs or radioisotopes.
The specification is not enabled for “wherein the cytotoxic agent is selected from the group consisting of: DNA-targeting agents; microtubule-targeting agents; nucleoside analogs; and analogs, derivatives, or products thereof”. The specification does not adequately describe that the analogs, derivatives, or products thereof possess any particular conserved structure nor other disclosed distinguishing feature. Thus, the claims encompass a genus of agents without any structural features.
The specification is not enabled for anti-AXL antibodies that are effector-function-deficient antibody.
The specification is not enabled for antibodies with the functions recited in claims 25 and 38.
The specification is not enabled for antibodies with 90% identical sequences to the heavy and light chain sequences recited in claim 33.
The specification is not enabled for making and using the genus of the recited antibody and/or ADC molecules with these functions and using them in treating melanoma.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with the claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification discloses the anti-PD-1 antibodies comprising SEQ ID NOs 4 and 5; and SEQ ID NOs 9 and 10 which comprise the 6 CDRs of SEQ ID NOs 1-3 and 6-8 for use in the claimed invention. The specification discloses that the antiIL-27 antagonist may be a anti-EBI3 antibody or an anti-p28 antibody.
The specification is not enabled for making and using the following in the claimed method
The specification has not adequately disclosed the genus of these molecules which can be made and used commensurate in scope with the specification for use in a method of treating melanoma.
The specification discloses
The breadth of the instant claims encompasses antibodies with fewer than all six CDRs found in the heavy plus light chain binding region and ACDs thereof. The specification does not adequately disclose how the skilled artisan would make and use the various antibodies recited in the instant claims.
It is well established in the art that it is highly unpredictable which changes in amino acid sequence can be made in complementarity determining regions (CDRs) of a parental antibody such that the derived antibody retains the binding specificity and affinity of the parent antibody. The art of Mariuzza et al. (PTO-892; Reference V) reviews the structural basis of antigen-antibody recognition and teaches that a naturally occurring antibody comprises light and heavy chains. The antigen-combining site of an antibody is a three-dimensional structure, which fully comprises six "complementarity-determining regions" (CDRs), three each from the light and heavy chains. The amino acid sequences of the CDRs are hypervariable, as the amino acid residues contained within the CDRs determine much of antibody's antigen-binding specificity. Of the amino acid residues of the antibody contacting the antigen, six are within the light chain, nine are within the heavy chain, and two are within the constant or nearly constant "framework" regions (In particular, whole document). As such, one of skill in the art would not be able to make and use the genus of recited antibodies which would retain antigen binding function, because it is the 6 CDRs together which determine the antibody's antigen-binding specificity, but the specification sets forth that amino acids in CDRs can be varied from the parental antibody without identifying which CDR residues of the particularly disclosed antibodies that can be altered to retain antigen-binding function.
It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs 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 each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function.
Rudikoff et al. (PTO-892; Reference W) teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (In particular, page 1979, whole document). Rader et al. (PTO-892; Reference X) teaches in vitro selection and evolution of antibodies derived from phage display libraries by pairing either heavy or light chain of the rodent antibody with human polypeptide library for antibody humanization is unpredictable, and certain antibodies cannot be humanized using this approach; and in addition, antibodies consisting of the same heavy chain paired with light chains that differ in light chain CDR3 and elsewhere in VL can obtain undesired feature of binding different epitopes of the same antigen (In particular, discussion on pages 8914-8915, whole document). Accordingly, since it is known in the art that antibodies can comprise the same CDR3 amino acid sequences but not share antigen-binding specificity, it is apparent that one of skill in the art could not be able to make and use the genus of recited antibodies which would retain binding specificity and antagonist function. For these reasons, one of skill in the art would not recognize that the specification is not enabled for the use of the genus of the recited antibodies.
The specification provides insufficient direction or guidance regarding how to produce antibodies as broadly defined by the claims other than the antibodies recited in claim 34. One of ordinary skill in the art would be required to practice undue experimentation to practice the invention commensurate in scope with the claimed.
In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue trials and errors to make and use the claimed antibodies with less than six CDRs.
As evidenced by the state of the art, cancer is complex and data provided in the specification cannot be used by one of ordinary skill in the art to make and genus of antibodies, ADCs and compositions thereof to treat melanoma as claimed.
The specification does not adequately teach how to effectively treat melanoma or reach any therapeutic endpoint in animals by administrating the recited compositions. The specification does not teach how to extrapolate data obtained from the disclosed studies to the development of effective in vivo animal therapeutic treatment, commensurate in scope with the claimed invention.
It is not enough to rely on the disclosed studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to efficacy in humans or animals (emphasis added). Ex parte Maas, 9 USPQ2d 1746
In view of the absence of a specific and detailed description in Applicant's specification of how to effectively use the genus of methods claimed, absence of working examples providing evidence which is reasonably predictive that the genus of methods that are effective for in vivo treatment of disease, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed methods with a reasonable expectation of success.
Substantiating evidence may be in the form of animal tests, which constitute recognizedscreening procedures with clear relevance to efficacy in humans. See Ex parte Krepelka, 231USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein. Ex parteMaas, 9 USPQ2d 1746.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s arguments filed on 03/28/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully traverses this rejection. The claimed invention is based on the surprising discovery that anti-AXL antibodies or ADCs thereof reduced tumor volume and prolonged life span in well-established xenograft models of PD-1 resistant tumors (see, Examples 5 and 6), and also reduced tumor diameters in two case studies of human patients previously treated with the PD-1 inhibitor, pembrolizumab (see, pages 70-73).
Accordingly, one of ordinary skill in the art would reasonably accept that the disclosure in the present application is fully enabling based on the teachings and working data that is provided. More specifically, the present disclosure describes 16 different anti-AXL antibodies and 3 antibody variants, and further provides well-known methods of producing and testing additional anti-AXL antibodies. The specification further provides well-known assays for determining antibody binding affinity and competition assays (e.g., for Gas6). Also provided are examples of antibody-drug conjugates as well as methods of producing conjugates containing cytotoxic agents, chemotherapeutic drugs, or radioisotopes.
Furthermore, the Office's assertion that the specification does not adequately teach how to reach any therapeutic endpoint in animals or extrapolate animal data to show clear relevance in humans is incorrect. The requirements of the law for obtaining a patent are distinct from the requirements for obtaining government approval to market a particular drug for human consumption. "Title 35 does not demand that such human testing occur within the confines of Patent and Trademark (PTO) proceedings." In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995). Moreover, as discussed above, the data provided in the application includes in vivo studies in widely accepted murine tumor models, as well as results of a clinical trial in human patients including case studies in which patients previously treated with the PD-1 inhibitor, pembrolizumab, clearly demonstrated responsiveness (i.e., tumor reduction) after treatment with an ADC containing an anti-AXL antibody.
In short, based on the knowledge and skill in the art at the relevant filing date, as well as the guidance and working data in the specification, the skilled artisan would not have reasonably doubted that the claimed methods are fully enabled. It is well established that the enablement requirement is satisfied if one of ordinary skill in the art would reasonably accept the supporting disclosure as being enabling based on the teachings and/or data that is provided (In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995)).
Accordingly, for at least the foregoing reasons, reconsideration and withdrawal of this rejection is respectfully requested.”
It is the Examiner’s position that Applicant’s argument that “the claimed invention is based on the surprising discovery that anti-AXL antibodies or ADCs thereof reduced tumor volume and prolonged life span in well-established xenograft models of PD-1 resistant tumors (see, Examples 5 and 6), and also reduced tumor diameters in two case studies of human patients previously treated with the PD-1 inhibitor, pembrolizumab (see, pages 70-73).” is not persuasive. If Applicant was surprised that the anti-AXL antibodies used in the specification reduced tumor volume and prolonged life span in their mouse model then that is evidence that it would require undue experimentation to make and use the invention commensurate in scope with the claims which encompass the use of all anti-human AXL antibodies to treat all cancers, including the huge number of specific cancers recited in claim 8. Contrary to Applicant’s assertion one of ordinary skill in the art would not reasonably accept that the disclosure is full enabling to treat all cancers with all anti-AXL antibodies. The art of et Yadav eta l. (PTO-892; Reference U) al. teaches “these agents may have better specificity to AXL-expressing cancer cells and potentially reduce off-target effects. However, severe adverse effects may stem from inducing unwanted cytotoxicity through targeting normal cellular function. In particular, the role of AXL in platelet function will require attention to hemostasis in clinical trials. Additionally, targeting AXL-mediated functions in multiple immune cells may adversely impact immune responses.” The Yadav reference teaches that “Tilvestamab (BGB149), a first-in-class anti-AXL IgG1 monoclonal antibody, inhibits AXL signaling and reduced tumor size in preclinical RCC models [61]. This agent was in phase I trial as monotherapy (NCT04893551) in relapsed, platinum-resistant, high-grade serous ovarian cancer (HGSOC) patients. The trial was terminated after the dose escalation phase of the study [208].”
Furthermore, Liu et al. (PTO-892; Reference U) teaches that “Monoclonal antibodies against AXL target the extracellular segment of AXL, selectively disrupting receptor‒ligand interactions to inhibit downstream signaling. Several monoclonal antibodies, including Tilvestamab (BGB149), YW327.6S2, MAb173, and D9/E8, have shown anti-AXL activity in preclinical studies, significantly inhibiting tumor growth, migration, and invasion in various solid tumors [167, 168].” As such, antibodies which bind to any portion of human AXL will not be useful to selectively disrupt receptor-ligand interactions and inhibit downstream signaling.
The rejection stands for reasons of record.
12. Claims 1, 3, 5, 8, 11-12, 16, 18, 22, 25, 31, 33-34, 38, 46, 49, 52, 59-64, 66-67, 71, 77, 85, 99, 102-103, 105-107, 121, 124 and 126 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.
The specification does not adequately describe the broad genus of anti-“AXL” antibodies and ADC. The specification has described 9 anti-AXL antibodies as well as 3 variants of these antibodies, but this does not adequately support the broad scope of the recited antibodies and immunoconjugates.
The specification does not adequately describe the genus of ADCs comprising antibodies and cytotoxic agents, chemotherapeutic drugs or radioisotopes.
The specification does not adequately describe “wherein the cytotoxic agent is selected from the group consisting of: DNA-targeting agents; microtubule-targeting agents; nucleoside analogs; and analogs, derivatives, or products thereof”. The specification does not adequately describe that the analogs, derivatives, or products thereof possess any particular conserved structure nor other disclosed distinguishing feature. Thus, the claims encompass a genus of agents without any structural features.
The specification does not adequately describe anti-AXL antibodies that are effector-function-deficient antibody.
The specification does not adequately describe antibodies with the functions recited in claims 25 and 38.
The specification does not describe antibodies with 90% identical sequences to the heavy and light chain sequences recited in claim 33.
The specification has not adequately described the structure of the antibody and/or ADC molecules with these functions. Therefore, the skilled artisan cannot envision all the antibody, ADC and method possibilities recited in the instant claims.
Consequently, conception cannot be achieved until a representative description of the structural and functional properties of the claimed invention has occurred, regardless of the complexity or simplicity of the method.
As evidenced by the art of Goel et al. (PTO-892 mailed on 09/30/2024; Page 2; Reference U), Khan et al. (PTO-892 mailed on 09/30/2024; Page 2; Reference V) and Poosarla et al. (PTO-892 mailed on 09/30/2024; page 2; Reference W), antibody specificity for a particular antigen does not correlate with any particular structure for the antibodies themselves. It was well known to those skilled in the art at the time the invention was made that minor structural differences among structurally related antibodies or compositions thereof could result in substantially different binding activities. Given the lack of guidance in the specification, it is unpredictable which antibodies with which structures would bind to the recited sequences. The specification does not disclose a correlation between the structure of the antibodies themselves and their function of binding to the recited sequences such that a skilled artisan would have known what antibody structures possess the claimed functions.
U.S. Court of Appeals for the Federal Circuit recently 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. Id.
The specification does not provide adequate written description of the claimed invention.
The legal standard for sufficiency of a patent's (or a specification's) written description is
whether that description "reasonably conveys to the artisan that the inventor had possession at
that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 U.S.P.Q.2d 1111
(Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the
applicant had possession at the time of invention of the claimed inventions.
The claims also encompass antibodies with variants of the recited amino acid sequences. The claims recite variable region sequences containing amino acids not found in the antibodies that were actually produced in the examples in the specification which actually bind to AXL. The claims recite combinations of CDRs wherein the combinations encompass antibodies other than the specific antibodies produced in the examples in the specification which actually bind to AXL.
It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in
order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites.
MacCallum, et al. (PTO-892 mailed on 09/30/2024; Page 2; Reference X) analyzed many different antibodies for interactions with antigen and state that although CDR3 of the heavy and light chain dominate, a number of residues outside the standard CDR definitions make antigen contacts (see page 733, right column) and non-contacting residues within the CDRs coincide with residues as important in defining canonical backbone conformations (see page 735, left column). De Pascalis, et al. (PTO-892 mailed on 09/30/2024; Page 3; Reference U) demonstrates that grafting of the CDRs into a human framework was performed by grafting CDR residues and maintaining framework residues that were deemed essential for preserving the structural integrity of the antigen binding site (see page 3079, right column). Although abbreviated CDR residues were used in the constructs, some residues in all 6 CDRs were used for the constructs (see page 3080, left column). Thus it is unpredictable as to what amino acids can be changed in the original intact antibodies disclosed in the specification wherein the antibodies would still function. Thus, the skilled artisan cannot envision the detailed structure of the encompassed invention and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation.
Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. In the instant application, the amino acid sequence itself or isolated protein is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016. In view of the aforementioned problems regarding description of the claimed invention, the specification does not provide an adequate written description of the invention claimed herein.
See The Regents of the University of California v. Eli Lilly and Company, 43 USPQ2d 1398,
1404-7 (Fed. Cir. 1997). In University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d 1225
(Fed. Cir. 1995) the inventors claimed a genus of DNA species encoding insulin in different vertebrates or mammals, but had only described a single species of cDNA which encoded rat insulin. The court held that only the nucleic acids species described in the specification (i.e. nucleic acids encoding rat insulin) met the description requirement and that the inventors were not entitled to a claim encompassing a genus of nucleic acids encoding insulin from other vertebrates, mammals or humans, id. at 1240. The Federal Circuit has held that if an inventor is "unable to envision the detailed constitution of a gene so as to distinguish it from other materials.
. .conception has not been achieved until reduction to practice has occurred", Amgen, Inc. v.
Chugai Pharmaceutical Co, Ltd., 18 U.S.P.Q.2d 016 (Fed. Cir. 1991). Attention is also directed
to the decision of The Regents of the University of California v. Eli Lilly and Company (CAFC,
July 1997) wherein is stated: "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, 222 USPQ 369, 372-373 (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. Thus, as we have previously held, a cDNA is not defined or described by the mere name "cDNA," even if accompanied by the name of the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA." See Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606.
As such, there is insufficient written description of the required kind of structure identifying information about the corresponding makeup of the claimed antibodies and ADC to demonstrate possession.
Applicant’s arguments filed on 03/28/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully traverses these rejections. The legal standard for sufficiency of a patent application's written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 U.S.P.Q.2d 1111 (Fed. Cir. 1991). As discussed above, the specification discloses the variable region sequences of the 16 different anti-AXL antibodies and 3 variants thereof, as well as data demonstrating efficacy of anti-AXL antibodies in both in vivo xenograft models of PD-1 inhibitor resistant cancers, and in humans previously treated with pembrolizumab.
Importantly, as articulated by the Federal Circuit, it is firmly established that the descriptive text needed to meet the Written Description requirement varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Capon, the Federal Circuit explained that "since the law is applied to each invention in view of the state of the relevant knowledge, its application will vary with differences in the state of knowledge in the field and differences in the predictability of the science." Id. Specifically, the Court stated that:
Precedent illustrates that the determination of what is needed to support generic claims to biological subject matter depends on a variety of factors, such as the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, the predictability of the aspect at issue, and other considerations appropriate to the subject matter. Id. at 1359 (emphasis added).
The Court further explained that "[a]s each field evolves, the balance also evolves between what is known and what is added by each inventive contribution." Id. at 1358.
Accordingly, under current law, the standard for meeting the Written Description requirement differs for every patent specification depending upon a number of factors, including the scientific knowledge in existence at the time of the invention, the skill in the art, and the predictability of the claimed subject matter in view of the of the information provided by Applicant. When considered in light of these factors, the present disclosure clearly meets the Written Description requirement and demonstrates that Applicants were in possession of the claimed invention at the time of filing.
Applicant respectfully submits that, as of the filing date of the present application, it had become clearly established that antibodies which bind human AXL can be predictably generated, and variants engineered according to routine, well-known methods. Methods for generating/identifying such antibodies, as well as testing them to confirm the ability to bind human AXL were well known at the relevant filing date and described in the present application.
Moreover, it is well established that what is conventional or well known to one of ordinary skill in the art at the relevant filing date need not be disclosed in detail. Id at 1357.
Accordingly, in view of the ample description in the specification and knowledge in the art, one of ordinary skill in the art would have readily understood Applicant to be in possession of the genus of anti-AXL antibodies for use in the claimed method as of the relevant filing date.
Moreover, with respect to the drug portion of the antibody-drug conjugates (ADCs), it is important to note that the claims are not directed to the discovery or generation of new compounds (e.g., cytotoxic agents, chemotherapeutic drugs or radioisotopes as recited in the claims), but rather to the novel use of these known classes of compounds for use in an antibody drug conjugate for a particular therapeutic application (i.e., a method of treating cancer resistant to or predicted to be resistant to PD-1 inhibitors). The description necessary to establish written description for a novel genus of compounds logically differs from that needed to establish written description for a method of using a known genus of compounds to achieve a particular purpose. Indeed, the courts have recognized a distinction between these two types of claims and have warned against viewing such method claims like composition claims when assessing written description. See, e.g., Erfindergemeinschaft UroPep GbR v. Eli Lilly and Co., 276 F.Supp.3d 629 (E.D. Tex. Oct. 21, 2017), affirmed by United States Court of Appeals, Federal Circuit on October 10, 2018; see also Exparte AMBATI, Appeal 2017-011580 at 6 (PTAB Jan 29, 2019). The court in UroPep discussed the important differences between claims drawn to the identification of particular inhibitors versus claims to the use of compounds having the inhibiting feature for a particular therapeutic purpose, as in the present claims (citing University ofRochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2006). The PTAB in Exparte AMBATI took a similar position, noting that the level and type of description needed for claims drawn to compounds differs from that needed for claims drawn to a new use of such compounds.
Applicant respectfully notes the present rejection fails to account for this important distinction. As discussed above, the present claims are not drawn to a genus of new compounds, but rather to a new use for known compounds (e.g., cytotoxic agents, chemotherapeutic drugs or radioisotopes) in the generation of ADCs for a new method of treatment. In this regard, the specification provides working evidence and a clear rationale as to why inhibition of AXL by an ADC containing an anti-AXL antibody is effective in the treatment of cancers resistant to or predicted to become resistant to PD-1 inhibitors.
For at least the reasons discussed above, when viewed in light of the factors articulated in Capon v. Eshhar, it is clear that Applicant's disclosure meets the written description requirement with respect to the claimed methods. Accordingly, reconsideration and withdrawal of this rejection is respectfully requested.
Applicant has argues on the record that they were surprised that the anti-AXL antibodies used in the specification reduced tumor volume and prolonged life span in their mouse model. The specification has not adequately described the correlation between the structure of the antibodies with the function of binding to human AXL and treating cancer in addition to the other recited functions. The claims encompass the use of all anti-human AXL antibodies to treat all cancers, including the huge number of specific cancers recited in claim 8. The art of et Yadav eta l. (PTO-892; Reference U) al. teaches “these agents may have better specificity to AXL-expressing cancer cells and potentially reduce off-target effects. However, severe adverse effects may stem from inducing unwanted cytotoxicity through targeting normal cellular function. In particular, the role of AXL in platelet function will require attention to hemostasis in clinical trials. Additionally, targeting AXL-mediated functions in multiple immune cells may adversely impact immune responses.” The Yadav reference teaches that “Tilvestamab (BGB149), a first-in-class anti-AXL IgG1 monoclonal antibody, inhibits AXL signaling and reduced tumor size in preclinical RCC models [61]. This agent was in phase I trial as monotherapy (NCT04893551) in relapsed, platinum-resistant, high-grade serous ovarian cancer (HGSOC) patients. The trial was terminated after the dose escalation phase of the study [208].” As such, there is no demonstration in the art of the genus of the molecules encompassed by the claimed invention having the recited functions. The description in the specification is not sufficient to provide written support for the genus of antibodies encompassed.
MPEP § 2163 sets forth guidelines for the examination of patent applications under the 35 U.S.C. § 112, 1st paragraph, “Written Description” requirement:
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of 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; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "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." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)….
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation."
The art of Liu et al. (PTO-892; Reference U) teaches that “Monoclonal antibodies against AXL target the extracellular segment of AXL, selectively disrupting receptor‒ligand interactions to inhibit downstream signaling. Several monoclonal antibodies, including Tilvestamab (BGB149), YW327.6S2, MAb173, and D9/E8, have shown anti-AXL activity in preclinical studies, significantly inhibiting tumor growth, migration, and invasion in various solid tumors [167, 168].” As such, antibodies which bind to any portion of human AXL will not be useful to selectively disrupt receptor-ligand interactions and inhibit downstream signaling. The specification has not demonstrated a correlation between the structure of the antibodies and binding the extracellular portion of human AXL. Additionally, the specification’s description does not adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Applicant has admitted on the record that the effect described in the specification of treating tumors was surprising. As such, the invention is in an unpredictable art and the genus of antibodies and variants and antibody drug conjugates has not been adequately described.
The rejection stands for reasons of record.
13. 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.
14. Claim(s) 1, 3, 5, 8, 11-12, 16, 22, 46, 49, 52, 59, 121 and 126 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/193430 (PTO-892 mailed on 09/30/2024; Reference N) as evidenced by Rizzetto et al. (PTO-892 mailed on 09/30/2024; Reference U).
WO 2015/193430 teaches human or humanized anti AXL antibodies of any isotype and ADC’s thereof conjugated to MMAE, including those with reduced effector functions, to be used for treating cancers such as melanomas (In particular, whole document, pages 25, 28, 31 and 51-52).
Rizzetto et al. is being used as an evidentiary reference to teach that the programmed death (PD-1) inhibitor pembrolizumab was shown to increase survival in metastatic patients. In three clinical trials in patients with advanced melanoma, therapy with pembrolizumab alone resulted in a 30–40% complete clinical response. Specifically, in a study on advanced melanoma, pembrolizumab monotherapy resulted in a 3-year overall survival (OS) of 41% in patients previously treated with ipilimumab and 45% in therapy-naïve patients.
As such all melanoma patients are encompassed by the recitations of being “predicted to be or become resistant to” and “predicted to fail to respond to” the programmed death (PD-1) inhibitor pembrolizumab. All melanoma patients are predicted to be become resistant to or to fail to respond to pembrolizumab because 60-70% of patients do not have a complete clinical response and any particular patient may be predicted to become one of the patients that does not have a complete clinical response. It is noted that these recitations do not require that pembrolizumab is ever administered to the encompassed patient.
The reference teachings anticipate the claimed invention.
Applicant’s arguments filed on 03/28/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully traverses this rejection. At the outset, Applicant notes that the present application was filed under 35 U.S.C. § 371 on March 8, 2020, and claims priority to PCT/EP2019/059171 filed on April 10, 2019, and to U.S. Provisional Application No. 62/655417, filed on April 10, 2018. Accordingly, Rizzetto et al., which published August 24, 2023, does not qualify as prior art to the presently claimed invention.
With regard to WO 2015/193430, Applicant respectfully submits that this reference does not disclose treatment of cancer with an anti-AXL antibody or ADC thereof, wherein the cancer (i) is resistant to or is predicted to be or become resistant to; (ii) has failed to respond to, or is predicted to fail to respond to; and/or (iii) has relapsed after or is predicted to relapse, after treatment with an inhibitor of the interaction between a programmed cell death-1 (PD-1)receptor and its ligand.”
It is the Examiner’s position that Rizzetto et al.is only being used as an evidentiary reference. As such, the reference does not need to be prior art. As stated in the rejection, Rizzetto is being used to show the inherency of the method taught by WO 2015/193430. All melanoma patients are predicted to be become resistant to or to fail to respond to pembrolizumab because 60-70% of patients do not have a complete clinical response and any particular patient may be predicted to become one of the patients that does not have a complete clinical response.
The rejection stands for reasons of record.
15. 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.
16. Claims 1, 102-103 and 105-107 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/193430 (PTO-892 mailed on 09/30/2024; Reference N) as evidenced by Rizzetto et al. (PTO-892 mailed on 09/30/2024; Reference U).
WO 2015/193430 and Rizzetto et al. have been discussed supra.
The claimed invention differs from the prior art in the dosage and timing recitations of claims 102-103 and 105-107.
It would have been obvious to one of ordinary skill in the art at the time Applicant's invention was made to determine all operable features of optimal timing and dosage of administration of the components and because timing and dosage are art-recognized result-effective variables which would have been routinely determined and optimized in the pharmaceutical and cancer treatment art. The determination of the optimal dosage including timing, frequency and route of treatment are well within the purview of one of ordinary skill in the art at the time the invention was made and lend no patentable import to the claimed invention. 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.
From the combined teachings of the references, it is 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.
Applicant’s arguments filed on 03/28/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully traverses these rejections. As discussed above, Rizzetto et al., which published August 24, 2023, does not qualify as prior art to the presently claimed invention.
Moreover, the primary reference WO 2015/193430 neither teaches or suggests the presently claimed methods which are directed to treatment of a cancer that (i) is resistant to or is predicted to be or become resistant to; (ii) has failed to respond to, or is predicted to fail to respond to; and/or (iii) has relapsed after or is predicted to relapse, after treatment with an inhibitor of the interaction between PD-1 and its ligand. Accordingly, the skilled artisan provided with teachings of WO 2015/193430 would not have had any motivation to use an anti- AXL antibody or drug conjugate thereof in the presently claimed method, let alone arrive at the claimed dosage regimens with any expectation of success.
Additionally, the teachings of WO 2016/005593 fail to cure the deficiencies of WO 2015/193430. Indeed, while W02016/005593 also discloses anti-AXL antibodies and their use in the treatment of cancer, this publication does not even mention PD-1 or treatment of a cancer that (i) is resistant to or is predicted to be or become resistant to; (ii) has failed to respond to, or is predicted to fail to respond to; and/or (iii) has relapsed after or is predicted to relapse, after treatment with an inhibitor of the interaction between PD-1 and its ligand.
In short, absent impermissible hindsight, the skilled artisan even when presented with the combined teachings of WO 2105/19430 and WO 2016/005593 would have had no reason motivation to arrive at the presently claimed method with a reasonable expectation of success.
Moreover, contrary to the Office's assertions, the presently claimed dosage regimens would not have been a simple matter of routine optimization. Obviousness cannot be established based on an unsupported allegation that a therapeutic invention is the result of "routine optimization," given the unpredictable and complex nature of therapeutics. (Swiss Pharma InternationalAG v. Biogen IDEC (IPR2016-00915, October 20, 2016); In re Stepan Co., No. 2016-1811 (Fed. Cir. Aug. 25, 2017)).”
As stated supra, it is the Examiner’s position that Rizzetto et al.is only being used as an evidentiary reference. As such, the reference does not need to be prior art. As stated in the rejection, Rizzetto is being used to show the inherency of the method taught by WO 2015/193430. All melanoma patients are predicted to be become resistant to or to fail to respond to pembrolizumab because 60-70% of patients do not have a complete clinical response and any particular patient may be predicted to become one of the patients that does not have a complete clinical response.
The determination of the optimal dosage including timing, frequency and route of treatment are well within the purview of one of ordinary skill in the art at the time the invention was made and lend no patentable import to the claimed invention One of ordinary skill in the art would have a reasonable expectation of success in finding the optimal dosage, timing and frequency of administration for a particular route of administration. This is routine in the pharmaceutical art for all therapeutics.
The rejection stands for reasons of record.
17. Claim(s) 1, 102-103 and 105-107 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/193430 (PTO-892 mailed on 09/30/2024; Reference N) in view of WO 2016/005593 (PTO-892 mailed on 09/30/2024; Reference O) as evidenced by Rizzetto et al. (PTO-892 mailed on 09/30/2024; Reference U).
WO 2015/193430 and Rizzetto et al. have been discussed supra.
The claimed invention differs from the prior art in the recitation of the antibody of SEQ ID NO. 1 comprising CDRs of SEQ ID NO. 36, 37 and 38; and SEQ ID NO. 2 comprising CDRs of SEQ ID NO. 39, GAS and 40 of claims 31, 33-34.
WO 2016/005593 teaches antibodies specific for Axl and ADCs thereof comprising the antibodies and MMAE linked to the antibody through a val-cit, The reference teaches the Axl-specific antibody of instant/reference SEQ ID NO. 1 comprising instant/reference CDRs of SEQ ID NO. 36, 37 and 38; and instant/reference SEQ ID NO. 2 comprising instant/reference CDRs of SEQ ID NO. 39, GAS and 40.
It would have been obvious to one of ordinary skill in the art at the time of invention to have used the antibodies of WO 2016/005593 in the method of treating melanoma using axl-specific antibodies of WO 2015/193430.
From the combined teachings of the references, it is 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.
Applicant’s arguments filed on 03/28/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully traverses these rejections. As discussed above, Rizzetto et al., which published August 24, 2023, does not qualify as prior art to the presently claimed invention.
Moreover, the primary reference WO 2015/193430 neither teaches or suggests the presently claimed methods which are directed to treatment of a cancer that (i) is resistant to or is predicted to be or become resistant to; (ii) has failed to respond to, or is predicted to fail to respond to; and/or (iii) has relapsed after or is predicted to relapse, after treatment with an inhibitor of the interaction between PD-1 and its ligand. Accordingly, the skilled artisan provided with teachings of WO 2015/193430 would not have had any motivation to use an anti- AXL antibody or drug conjugate thereof in the presently claimed method, let alone arrive at the claimed dosage regimens with any expectation of success.
Additionally, the teachings of WO 2016/005593 fail to cure the deficiencies of WO 2015/193430. Indeed, while W02016/005593 also discloses anti-AXL antibodies and their use in the treatment of cancer, this publication does not even mention PD-1 or treatment of a cancer that (i) is resistant to or is predicted to be or become resistant to; (ii) has failed to respond to, or is predicted to fail to respond to; and/or (iii) has relapsed after or is predicted to relapse, after treatment with an inhibitor of the interaction between PD-1 and its ligand.
In short, absent impermissible hindsight, the skilled artisan even when presented with the combined teachings of WO 2105/19430 and WO 2016/005593 would have had no reason motivation to arrive at the presently claimed method with a reasonable expectation of success.
Moreover, contrary to the Office's assertions, the presently claimed dosage regimens would not have been a simple matter of routine optimization. Obviousness cannot be established based on an unsupported allegation that a therapeutic invention is the result of "routine optimization," given the unpredictable and complex nature of therapeutics. (Swiss Pharma InternationalAG v. Biogen IDEC (IPR2016-00915, October 20, 2016); In re Stepan Co., No. 2016-1811 (Fed. Cir. Aug. 25, 2017)).”
As stated supra, it is the Examiner’s position that Rizzetto et al.is only being used as an evidentiary reference. As such, the reference does not need to be prior art. As stated in the rejection, Rizzetto is being used to show the inherency of the method taught by WO 2015/193430. All melanoma patients are predicted to be become resistant to or to fail to respond to pembrolizumab because 60-70% of patients do not have a complete clinical response and any particular patient may be predicted to become one of the patients that does not have a complete clinical response.
Applicant’s argument that “W02016/005593 does not even mention PD-1 or treatment of a cancer that (i) is resistant to or is predicted to be or become resistant to; (ii) has failed to respond to, or is predicted to fail to respond to; and/or (iii) has relapsed after or is predicted to relapse, after treatment with an inhibitor of the interaction between PD-1 and its ligand” is unpersuasive. There is no hindsight being used. Applicant’s argument that, the presently claimed dosage regimens would not have been a simple matter of routine optimization is unpersuasive. The Examiner has not asserted an unsupported allegation of routine optimization.
18. No claim is allowed.
19. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 date of this final action.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 27, 2025
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights