DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Pursuant to the amendment dated 04/13/2026, claims 4-8, 16 and 17 have been cancelled and new claims 20-26 have been added. Claims 20-22 are directed to a method; however, they are dependent from composition claims 14 or 9. In the interest of compact prosecution the examiner has treated these claims as reading on prior art compositions; however, as discussed below, they are indefinite under 35 USC 112(b) as being hybrid claims. Upon amendment, if the claims are properly directed to a method, they will be withdrawn.
Claims 1-3, 9-15, and 18-26 are pending. Claims 18 and 19 stand withdrawn without traverse.
The species election for condition (TNBC) remain in effect.
Claims 1-3, 9-15, and 20-26 are under current examination.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
The sequence listing filed 04/13/2026 corrects the missing SEQID for SEQID No. 8; however this application is a US national phase with an international filing date of 10/26/2021 therefore ST.25 format is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims *************** 20-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 20, 21, and 22 are indefinite because the claims are directed to a method but depend from composition claims.
See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 9-15, and 20-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17840964 (reference application) in view of Li et al (Cancer Letters 418, pages 1-9; publication year: 2018) Danikas et al. (US20110268660; publication date: 11/03/2011) and Forsyth et al. (US20090215088; publication date: 08/27/2009).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Inter alia, the claims of the ‘964 application embrace a self-assembled therapeutic dendron-micelle, comprising a first amphiphilic dendron-coil, a second amphiphilic dendron-coil, and optionally a third amphiphilic dendron-coil; and an encapsulatedBRD4 ligand, or salt thereof, or a BRD4 ligand linker-ubiquitin ligase cereblon ligand or salt thereof (i.e. a chemotherapy agent); wherein the first amphiphilic dendron-coil comprises a first non-peptidyl, hydrophobic core-forming component covalently linked to a first polyester dendron which is covalently linked to first a poly(ethylene glycol) (PEG) moiety, wherein the first PEG moiety comprises a first conjugated therapeutic peptide; wherein the second amphiphilic dendron-coil comprises a second non-peptidyl, hydrophobic core-forming component covalently linked to a second polyester dendron which is covalently linked to a second poly(ethylene glycol) (PEG) moiety, wherein the second PEG moiety does not comprise a conjugated peptide, and optionally a third amphiphilic dendron-coil, wherein the third amphiphilic dendron- coil comprises a third non-peptidyl, hydrophobic core-forming component covalently linked to a third polyester dendron which is covalently linked to a third poly(ethylene glycol) (PEG) moiety, wherein the third PEG moiety comprises a second therapeutic binding peptide (i.e. three amphiphilic dendron-coils, two of which are conjugated to a peptide at the PEG moiety, and one of which that is not conjugated to a peptide at the PEG moiety). More specifically, the non-peptidyl hydrophobic core may be polycaprolactone (PCL), the polyester dendron may be a generation 3 polyester-8-hydroxyl-1-acetylene bis-MPA dendron, and the PEG may be mPEG (limitations of instant claims 1, 3, 9, 11, and 12). The linear hydrophobic polymer (e.g. the PCL segment) has a molecular weight ranging from 0.5 to 20 kDa and the PEG moiety has a molecular weight ranging from about 0.2 to 5 kDa (limitations of instant claims 10 and 13). The peptides may bind PD-L1, PD-1, or PDGFR, among others, and any combination of therapeutic peptides is considered within the scope of the ‘964 application. The PEG moiety may be linked to an image contrast agent. The claims of the ’964 application embrace a pharmaceutical composition formed from the claimed micelles.
The claims of the cited application embrace a PD-L1 ligand; however, they do not embrace EGFR binding ligands.
Li discloses that co-treatment with EGFR inhibitors and PD-1/PD-L1 immune checkpoint inhibitors may improve outcome in cancer (NSCLC) by targeting signaling in patients with EGFR activating mutations and immune suppression in the environment of the tumor (title, abstract).
Danikas discloses the sequence LARLLT (instant SEQID6) binds the EGFR.
Forsyth discloses that the sequence YHWYGYTPQNVI (instant SEQID5) is an EGFR peptide (i.e. an EGFR binding peptide).
The artisan of ordinary skill would have been motivated to use the above peptides as ligands in the micelle of the cited patent in order to improve treatment outcomes for cancer patients and had expectation of success because this would merely require conjugating the peptides to the dendron coils using known methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 9-15, 20-24, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-16 of U.S. Patent No. 9212258 (cited in the IDS filed 04/21/2023); and
claims 1-35 of U.S. Patent No. 10543171
in view of Li et al (Cancer Letters 418, pages 1-9; publication year: 2018) and Boohaker et al. (Cancer Letters 434, page 11-21; publication year: 2018), as evidenced by Cutler et al. (US 20030185831; publication date: 10/02/2003).
Inter alia, the claims of the patents embrace a micelle (‘258 patent) or a method of using a micelle (‘317 patent) comprising multiple amphiphilic dendron coils, each formed from covalently linked non-peptidyl hydrophobic core, polyester dendron, and PEG. More specifically, the non-peptidyl hydrophobic core may be polycaprolactone (PCL), the polyester dendron may be a generation 3 polyester-8-hydroxyl-1-acetylene bis-MPA dendron, and the PEG may be mPEG (limitations of instant claims 1, 3, 9, 11, and 12). The linear hydrophobic polymer (e.g. the PCL segment) has a molecular weight ranging from 0.5 to 20 kDa and the PEG moiety has a molecular weight ranging from about 0.2 to 5 kDa (limitations of instant claims 10 and 13). The micelle encapsulates a cancer drug (i.e. a chemotherapy drug; limitation of instant claim 2), and the PEG moiety can be conjugated to a ligand. Turning to the specification, the term “ligand” embraces “Interferon (IFN)-alpha, IFN-beta, IFN-gamma, CXCL10, Interleukin (IL)-4, IL-12, Transforming Growth Factor Beta inhibitor, a gamma-type Peroxisome Proliferator-Activated Receptor (PPARy) ligand, an angiotensin activity inhibitor, a Platelet-Derived Growth Factor (PDGF) inhibitor” (col 7-8 of the ‘258 patent; col 10 of the ‘171 patent) as well as Herceptin (i.e. an inhibitor of EGFR; see Cutler’s claim 15: EGF inhibitor is Herceptin; col 8 of the ‘258 patent, col 11 of the ‘171 patent). The aforementioned peptides affect the immune system and are therefore considered “immunotherapeutic” (limitation of instant claim 1). The specification also indicates that ligand embraces folic acid (Fig 1).
With regard to the requirement that the micelle comprise a first through third (instant claim 1), or fourth (instant claim 3) amphiphilic dendron-coil, the patents embrace micelles formed from greater than one amphiphilic dendron-coil. With regard to the recitation in instant claim 1 requiring that one of the third amphiphilic dendron coils lack a conjugated ligand, noting that instant claim language describing the first – third amphiphilic dendron coils embraces micelles in which all three amphiphiles are identical except that two must have a ligand conjugated to the PEG moiety, and one must not have a ligand conjugated to the PEG moiety, it would have been obvious to one of ordinary skill that the micelle must contain a sufficient number of amphiphilic molecules to stably maintain the micelle structure (e.g. a vesicle formed from the thermodynamic stability achieved when hydrophobic moieties interact with each other, and hydrophilic moieties interact with each other and the surrounding solvent). The examiner considers any arrangement of ligand-containing vs. ligand-lacking amphiphiles to have been prima facie obvious so long as the micelle remains functional, i.e. a thermodynamically stable micelle structure that is also capable of achieving the object intended in linking the PEG moiety to a ligand.
With regard to claims 20 and 21, the specification indicates that the term “ligand” embraces folic acid (i.e. a cancer cell binding ligand; see fig 1).
With regard to claim 26, the examiner considers it a matter of routine for one of ordinary skill to optimize the parameters taught by the cited patents such that a micelle is formed, targeting the list of biological molecules disclosed as achievable, to include adjusting amounts of each different dendron coil present in the micelle.
With regard to claim 23, in practicing the full scope of the 258 and 171 applications, the hydrophobic core-forming components embrace greater than one molecular weight, thus, the patents teach molecular weights that are different.
With regard to claim 1, Although the claims of the cited patents embrace multiple different peptide ligands that modulate the immune system, as noted above, there is not a particular reason set forth in the cited patent claims to select a first and a second immunotherapeutic peptide to conjugate to the amphiphilic dendron-coil.
Li discloses that co-treatment with EGFR inhibitors and PD-1/PD-L1 immune checkpoint inhibitors may improve outcome in cancer (NSCLC) by targeting signaling in patients with EGFR activating mutations and immune suppression in the environment of the tumor (title, abstract).
Boohaker discloses a peptide inhibitor for the PD-1/PD-L1 interaction that allows for CTL (cytotoxic T-lymphocyte) anti-tumor activity (abstract, title).
It would have been prima facie obvious to select an EGF ligand such as Herceptin from the ligands embraced by the cited patents for conjugation with the amphiphilic dendron-coils and combine it for co-delivery with a PD-1/PD-L1 inhibitory peptide disclosed by Boohaker to arrive at a micelle comprised of amphiphilic dendron-coils conjugated to both of these immunotherapeutic peptides, either together or separately, along with sufficient unconjugated amphiphilic dendron-coils to form a stable micelle from the amphiphiles bearing the therapeutic peptides. The skilled artisan would have been motivated to combine e.g. Herceptin with a PD-1/PD-L1 inhibitory peptide in order to both interrupt pro-tumorigenic EGFR signaling and attenuate immunosuppression in the vicinity of the tumor. The artisan of ordinary skill would have had reasonable expectation of success because the patents embrace dendron-coils conjugated to any ligand, the amphiphilic dendron coils had been established to form micelles, and because this particular combination of ligands was known to show benefit in anti-cancer therapy.
With regard to instant claims 3 and 14, the claim as it is currently worded only requires a ligand to be present anywhere within the micelle. This reads on combinations of any of the above ligands embraced by the cited patents.
With regard to claim 15, as the inventions of the cited patents embrace compositions intended for pharmaceutical use, they are considered to be pharmaceutical compositions.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-16 of U.S. Patent No. 9212258 (cited in the IDS filed 04/21/2023); and
claims 1-35 of U.S. Patent No. 10543171
in view of Li et al (Cancer Letters 418, pages 1-9; publication year: 2018) and Boohaker et al. (Cancer Letters 434, page 11-21; publication year: 2018), as evidenced by Cutler et al. (US 20030185831; publication date: 10/02/2003) as applied to claims 1-3, 9-15, 20-24, and 26 above, and further in view of Danikas et al. (US20110268660; publication date: 11/03/2011) and Forsyth et al. (US20090215088; publication date: 08/27/2009).
The relevant limitations of the 258 and 171 patents and the disclosures of Li, Boohaker are set forth above. None disclose the specific sequences required by instant claim 25.
As noted above, the cited patents embrace micelles bound to Herceptin, which binds to HER2 and inhibits EGFR.
Danikas discloses the sequence LARLLT (instant SEQID6) binds the EGFR.
Forsyth discloses that the sequence YHWYGYTPQNVI (instant SEQID5) is an EGFR peptide (i.e. an EGFR binding peptide).
It would have been prima facie obvious to include the EGFR binding peptides disclosed by Danikas and Forsyth as ligands in the dendron micelle embraced by the cited patents because they were known for the same purpose of binding EGFR. See MPEP 2144.06.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
On pages 9-10 Applicant requests that the examiner withdraw the double patenting rejections until the claims are in final form and otherwise in condition for allowance.
Applicants comments are noted. The rejections are based upon the current claim language in both applications and are therefore maintained.
On page 10, Applicant references the arguments traversing the obviousness rejection.
Please see the examiners response to the traversal of the rejection under 35 USC 103 below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 9-15, 20-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US9212258; issue date: 12/15/2015; cited in the IDS filed 04/21/2023) in view of Li et al (Cancer Letters 418, pages 1-9; publication year: 2018) and Boohaker et al. (Cancer Letters 434, page 11-21; publication year: 2018), as evidenced by Cutler et al. (US 20030185831; publication date: 10/02/2003).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US9212258; issue date: 12/15/2015; cited in the IDS filed 04/21/2023) in view of Li et al (Cancer Letters 418, pages 1-9; publication year: 2018) and Boohaker et al. (Cancer Letters 434, page 11-21; publication year: 2018), as evidenced by Cutler et al. (US 20030185831; publication date: 10/02/2003)as applied to claims 1-3, 9-15, 20-24, and 26 above, and further in view of Danikas et al. (US20110268660; publication date: 11/03/2011) and Forsyth et al. (US20090215088; publication date: 08/27/2009).
The claims are rejected as obvious under 35 USC 103 exactly as set forth in the double patenting rejection above.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
On page 8, applicant argues that Hong makes no mention of immunotherapeutic peptides and that Herceptin is, rather, an antibody not a peptide.
The examiner respectfully disagrees with the scope of the term “peptide” recited in the claim. There is no formal definition restricting the number of amino acids in the peptide in the instant application and as such, the term reads on anything containing a peptide bond.
On pages 8 and 9, Applicant describes the independent teachings of Li and Boohaker.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 8 and 9, Applicant describes achieving bispecific targeting with the claimed micelle formed from amphiphilic dendron coils and cites Example 4 of the specification as demonstrating an ability to bind PD-L1 and EGFR expressing cells, and that these peptides showed a similar level of binding/cell retention compared to whole antibodies. Applicant argues that this result is unexpected.
Please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, the result is unexpected, and of practical significance; however, the data are not commensurate in scope with the claims. In the experiments described in the specification, a specific dendron micelle having a specific chemical make-up was used; however, the instant claims embrace any dendron coil formed from any hydrophobic polymer that is non-peptidyl. Also, only claim 25 limits the peptide ligands to those ligands demonstrated to show surprisingly strong affinity for their targets. Finally, the examiner notes that the claim reads on a combination of EGFR binding peptides, and does not require the PD-1 ligand (SEQID7), as it is listed as an alternative to SEQID6 (EGFR binding). Neither evidence nor reasoned argument currently support that these surprising data would extend across the full scope of the claims as they are currently worded.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
Prosecution Insights