DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 31 July 2026, is acknowledged.
Claims 1, 6, and 16 been amended.
Claim 5 has been cancelled.
New claim 25 has been added.
Claims 1-3, 6-7, 9-19, and 21-25 are pending and under consideration in the instant Office Action, to the extent of the previously elected species poly(maleic acid-alt-1-octadecane) (PMHC18) as the amphiphilic polymer.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 103
The rejection of claim 5 under 35 U.S.C. § 103 has been rendered moot in view of Applicant’s cancellation of the claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 31 July 2026, was filed after the mailing date of the non-final Office Action on 2 March 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Maintained Rejections
Claim Rejections - 35 USC § 103
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, 5-7, 9-11, 16-19, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Herkel et al. (European Patent Application Publication No. EP 2591801 A1, published on 15 May 2013, provided by Applicant in IDS filed on 22 February 2023, hereafter referred to as Herkel) and Wooster et al. (WIPO International Publication No. WO 2017/136652 A1, published on 10 August 2017, provided by Applicant in IDS filed on 22 February 2023, hereafter referred to as Wooster).
Herkel teaches pharmaceutical compositions comprising micellar nanoparticles made of amphiphilic polymers which have “a peptide comprising at least one T cell epitope associated with the outside of the micelle” and methods of generating regulatory T cells, preventing diseases and conditions, and treating diseases and conditions consisting of administering said compositions (Abstract). The micelle comprising amphiphilic polymers may have a solid hydrophobic core, preferably an inorganic core, which comprises iron oxide, CdSe, silver, or gold (para. [0012]).
Herkel teaches that the diameter of the nanoparticles is 1-999 nm or preferably “about 5 to about 500 nm (para. [0018]). In a preferred embodiment, the amphiphilic polymer forming the micelle is poly(maleic anhydride-alt-1-octadecene) (PMCH18) (para. [0010]). In another preferred embodiment, a nanoparticle comprising an iron oxide core coated with PMCH18 is taught to have a diameter of 9-12 nm (para. [0015]). As a “virtue of the polymer forming the micelle, [the nanoparticle] may be negative charged or uncharged, preferably, it is negatively charged” (para. [0016]).
The peptide is taught to preferably covalently linked to the outside of the micelles, but may also be non-covalently associated (para. [0017]). Herkel further teaches that the peptide comprising a T cell epitope is “preferably covalently linked to the micelles, e.g., by carbodiimide or succinimide coupling” (para. [0017]). The peptide is taught to be 8-1,000 amino acids, preferably 9-60 amino acids or 10-20 amino acids, and to comprise “at least one T cell epitope” (para. [0018]). Finally, the nanoparticles are taught to be contained within a pharmaceutical composition that can be administered to a subject to generate regulatory T cells (claims 1 and 15).
Herkel does not teach the Mn of PMCH18 to be 1,000-6,000 g/mol nor the pH of their invention. These deficiencies are offset by the teachings of Wooster.
Wooster teaches particles comprising conjugates of an active agent designed to deliver said active agent, methods of making the conjugates and particles, and methods of administering formulations containing the particles and conjugates to treat or prevent cancer or diseases (Abstract). The particles of Wooster’s invention may be polymeric nanoparticles, micelles of polymers and conjugates, or composition nanoparticles and the aforementioned conjugates may be encapsulated into the particles, embedded in the particle/medium interface, or “deposited on the surface of the particles” (para. [0007]). In an embodiment wherein the particles are polymeric, the polymers are taught to be hydrophobic, hydrophilic, or amphiphilic (para. [00149]). In the case that the polymers are amphiphilic, Wooster teaches that they may be copolymers of a hydrophobic polymer block and a hydrophilic polymer block, with one example of a hydrophobic polymer being poly(maleic acid) (para. [00168] and [00172]). In polymeric micellar nanoparticles made of amphiphilic polymers, the hydrophilic block is taught to comprise 40-70% w/w of the diblock copolymer and have a Mn of 500-20,000 daltons, while the hydrophobic block may be 30-60% w/w and have a Mn of 500-10,000 daltons, resulting in a total Mn range of 1,000-17,000 daltons (para. [00185]). This range of Mn is taught to be necessary because “[w]ithin this range, the micelle of the amphiphilic deblock copolymer can be maintained stably” (para. [00185]). The conjugates are taught in certain embodiments to be targeting ligands, such as peptides, examples of which include a “bispecific T-cell engager” (para. [0071]), regulatory T cell molecules (para. [00126]), or other peptides which bind to a “cell-surface receptor” (para. [0071]).
Wooster further teaches that their particles may comprise a solid, hydrophobic, inorganic core such as superparamagnetic nanoparticles of iron oxide, which are known as SPION (para. [00223]). The SPION cores are taught to be coated with inorganic materials such as silica or gold, with organic materials such as phospholipids or peptides, or with drugs, proteins, or plasmids (para. [00223]). In one embodiment, SPION cores are taught to be surrounded by oleic acid-poloxamer copolymers and the conjugate is linked to the exterior of the nanoparticle (para. [00224-00225]). The linker is taught to be cleavable or not-cleavable (claims 17-18) and attached to the particle covalently or non-covalently (para. [00147]). In one embodiment, a polymeric micelle that delivers an active agent is taught to have a pH value of 3.0-7.0 (para. [00174]). Finally, Wooster teaches that the diameter of the whole nanoparticle should be 10 nm – 10,000 nm, or “about 25 nm to about 250 nm” (para. [00150]).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the above decisions, “the prior art taught carbon monoxide concentrations of ‘about 1-5%’ while the claim was limited to ‘more than 5%.’ The court held that ‘about 1-5%’ allowed for concentrations slightly above 5% thus the ranges overlapped.” With respect to ranges or amounts that do not overlap but are merely close, courts held that a prima facie case of obviousness also exists. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). These guidelines apply to the number average molecular weights, pH values, and nanoparticle diameters of the teachings of Herkel and Wooster. In each case, the ranges taught by Herkel and Wooster either encompass or significantly overlap with the ranges recited in the instant claims, resulting in a prima facie case of obviousness.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention of Herkel with the teachings of Wooster to arrive at the invention of claims 1-3, 6-7, 9-11, 16-19, and 21-24 because combining prior art elements according to known methods yields predictable results. Herkel teaches a micellar nanoparticle made of PMCH18 with a solid hydrophobic core, which may comprise iron oxide, CdSe, silver, or gold, and a peptide comprising at least one T cell epitope either covalently linked to the exterior via carbodiimide or succinimide coupling or non-covalently associated with the exterior. Herkel further teaches that size of the peptide may be 8-2000 amino acids, preferably 10-20 amino acids, and that the outer diameter of the nanoparticle is preferably 5-500 nm.
An ordinary skilled artisan would be motivated to use the teachings of Wooster to measure the pH of the invention of Herkel and adjust to be in the range of 3.0-7.0 because Herkel does not mention appropriate pH values and Wooster teaches the above range to be appropriate for nanoparticles that are intended to deliver active pharmaceutical agents, which is the application of the nanoparticles taught by Herkel. A person of ordinary skill in the art would further be motivated to try using lower average molecular weight polymers in view of the teachings of Wooster because Herkel only teaches the range 30,000-50,000 g/mol (Herkel, para. [0010]) and Wooster teaches that the Mn range of 1,000-17,000 daltons is necessary to maintain a stable micelle made from amphiphilic copolymers. It would be obvious to an artisan to try the lower range of molecular weight polymers, particularly in view of the teachings of Wooster, to produce a stable micelle and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success leads to predictable results. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-3, 6-7, 9-11, 16-19, and 21-24 in view of the teachings of Herkel and Wooster.
Response to Arguments
The Applicant’s arguments, filed on 31 July 2026, have been fully considered but are not persuasive.
Applicant argues in para. 2 of pg. 8 that the combination of the Herkel and Wooster references is not motivated because the previous Office Action did not demonstrate that “there had been a recognized problem or need in the art” to modify the average molecular weight of “alternating copolymers of maleic acid and an alkene” but instead demonstrated a recognized problem with respect to “amphiphilic diblock copolymers comprising poly lactic acid or its derivative as the hydrophobic block”. Applicant also argues in this para. that the Herkel reference does not indicate that the nanoparticles of their invention are unstable, therefore a person of ordinary skill would have “no reason to believe there was a need to use an amphiphilic polymer with Mn lower than 30,000-50,000 g/mol”.
Regarding the identification of a problem or need in the art, the Examiner disagrees with the Applicant’s interpretation of the MPEP – under the Applicant’s interpretation, a base reference (in this case the Herkel reference) would need to identify a problem within its own invention for another reference to be properly combined in an obviousness rejection. This reasoning is backwards; Wooster recognized a problem (in this case instability in nanoparticles resulting from amphiphilic copolymers) and presented a solution (the molecular weight range), which the rejection above argued would be obvious to use to provide stability to a nanoparticle resulting from amphiphilic copolymers.
Regarding Applicant’s argument that the amphiphilic copolymers must be identical for the teachings of one reference to be applicable to another, this requirement is not supported by the MPEP or previous case law – instead, prior art must be analogous to the claimed invention for use in an obviousness rejection. “In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention.” In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004), see also MPEP § 2141.01(a). “When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other.” See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023). The Herkel and Wooster references are directed to nanoparticles comprising amphiphilic copolymers, compositions containing the nanoparticles, and administration of the composition to a subject in need for therapeutic treatment. These references are in the same field of endeavor as the claimed invention and are therefore analogous art and proper to use in an obviousness rejection under 35 U.S.C. § 103 (see MPEP § 2141.01(a)). As stated above, it is not required that the cited references be analogous to each other and Applicant’s arguments are not found to be persuasive.
In para. 2 of pg. 9, Applicant argues that the previous Office Action did not demonstrate that there were “a finite number of identified, predictable potential solutions” to a recognized problem or need. The Examiner disagrees – the Wooster reference identified the number average molecular weight as a result-effective variable that can make a nanoparticle comprising amphiphilic copolymers stable or unstable. This is an identification of a finite potential solution. Further, Wooster teaches a number average molecular weight range that will provide stability to the nanoparticle which encompasses the range claimed in instant claims 1 and 25. Following the KSR decision, “the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” See MPEP § 2144.05.II.B. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05.II.A. Therefore, because the teachings of Wooster identified the number average molecular weight as a result-effective variable and taught a range of values that encompasses the claimed ranges, and because a person of ordinary skill would be capable of arriving at the claimed range via routine optimization within prior art conditions, the Applicant’s arguments are found to be unpersuasive.
Finally, in the para. that spans the bottom of pg. 9 and top of pg. 10, Applicant argues that the previous Office Action did not demonstrate a reasonable expectation of success because the copolymers of the Wooster and Herkel references are different. This is not found to be persuasive because, as stated above, “[w]hen more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other.” However, the Wooster and Herkel references are analogous to each other because, as mentioned above, both references are directed to nanoparticles comprising amphiphilic copolymers, compositions containing the nanoparticles, and administration of the composition to a subject in need for therapeutic treatment. Therefore, a person of ordinary skill in the art would reasonably expect to have success in modifying the number average molecular weight of an amphiphilic copolymer forming a nanoparticle to achieve stability when a prior art reference teaches that stability can be achieved with a particular range of number average molecular weights in amphiphilic copolymers that form nanoparticles.
Applicant is reminded that “[c]onclusive proof of efficacy is not required to show a reasonable expectation of success.” OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019). "To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.” See also MPEP § 2143.02. “[T]he expectation of success need only be reasonable, not absolute".
It is noted that in the antepenultimate para. of the section titled “Rejection under 35 U.S.C. § 103” on pg. 10, Applicant again has “incorporated herein by reference” their argument in the remarks filed on 11 September 2025, in response to the non-final Office Action mailed on 12 June 2025, regarding the surprising finding that their nanoparticles are easier to produce. As stated previously, Applicant has not provided an argument against the Office arguments in the final Office Action, mailed on 7 November 2025, regarding the failure to demonstrate unexpected results in accordance with MPEP § 716.02, and the argument is therefore found unpersuasive.
Maintained Rejections
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, 6-7, 9-11, 16-19, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-9 of U.S. Patent No. 12,016,931 B2 in view of Herkel (European Patent Application Publication No. EP 2591801 A1, published on 15 May 2013, provided by Applicant in IDS filed on 22 February 2023) and Wooster (WIPO International Publication No. WO 2017/136652 A1, published on 10 August 2017, provided by Applicant in IDS filed on 22 February 2023).
Claims 1-3 and 5-9 of patent ‘931 recite a pharmaceutical composition comprising three peptides covalently linked to the exterior of nanoparticles, said nanoparticles comprising “an amphiphilic polymer with a number average molecular weight (Mn) of 20,000 g/mol or less”. Claim 5 further limits the Mn of the amphiphilic polymer to be 1,000-6,000 g/mol. Claims 6-7 recite the amphiphilic polymer structure and one preferred polymer to be PMCH18. Claims 8-9 further recite the nanoparticles of their invention to have a solid iron oxide core and for the nanoparticle to have a diameter of “between 20 and 50 nm”.
The only differences between claims 1-3 and 5-9 of U.S. Patent No. 12,016,931 B2 and instant claims 1-3, 6-7, 9-11, 16-19, and 21-24 are that the claims of patent ‘931 do not recite the peptides to comprise at least one T cell epitope, the charge of the nanoparticles, nor the pH of the nanoparticles. These deficiencies are offset by the teachings of Herkel and Wooster.
Herkel and Wooster have been described above.
It would have been prima facie obvious to a person of ordinary skill in the art at the time of filing of the instant application to measure the pH and charge of the nanoparticles of patent ‘931 in view of the teachings of Herkel and Wooster because the former teaches the charge to be “a virtue of the polymer forming the micelle”, which is the same polymer (PMCH18) as recited in patent ‘931, and the latter teaches the pH range of 3.0-7.0 to be suitable for nanoparticles that are in pharmaceutical compositions to treat patients. Further, an artisan would be motivated to either confirm the peptides recited by patent ‘931 comprise T cell epitopes or to substitute the peptides for ones that comprise at least one T cell epitope in view of the teachings of Herkel because the reference teaches that autoimmune diseases may result from insufficient control of autoreactive lymphocytes (Herkel, para. [0002]). An artisan would reasonably expect that using peptides containing T cell epitopes linked to the exterior of the nanoparticles recited by patent ‘931 would have utility in treating autoimmune diseases, as taught by Herkel (Herkel, para. [0003-0004]). As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-3, 6-7, 9-11, 16-19, and 21-24 in view of claims 1-3 and 5-9 of U.S. Patent No. 12,016,931 B2 and the teachings of Herkel and Wooster.
Claims 1-3, 6-7, 9-11, 16-19, and 21-24 are directed to an invention not patentably distinct from claims 1-3 and 5-9 of commonly assigned U.S. Patent No. 12,016,931 B2 in view of Herkel and Wooster. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 12,016,931 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(I) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this section can be found above.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Herkel et al. (European Patent Application Publication No. EP 2591801 A1, published on 15 May 2013, provided by Applicant in IDS filed on 22 February 2023, hereafter referred to as Herkel) and Wooster et al. (WIPO International Publication No. WO 2017/136652 A1, published on 10 August 2017, provided by Applicant in IDS filed on 22 February 2023, hereafter referred to as Wooster).
Herkel has been described above.
Herkel does not teach the Mn of PMCH18 to be 3,000-5,000 g/mol. These deficiencies are offset by the teachings of Wooster.
Wooster has been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention of Herkel with the teachings of Wooster to arrive at the invention of claim 25 because combining prior art elements according to known methods yields predictable results. Herkel teaches a micellar nanoparticle made of PMCH18 with a solid hydrophobic core, which may comprise iron oxide, CdSe, silver, or gold, and a peptide comprising at least one T cell epitope either covalently linked to the exterior via carbodiimide or succinimide coupling or non-covalently associated with the exterior. Herkel further teaches that size of the peptide may be 8-2000 amino acids, preferably 10-20 amino acids, and that the outer diameter of the nanoparticle is preferably 5-500 nm.
An ordinary skilled artisan would be motivated to try using lower average molecular weight polymers in view of the teachings of Wooster because Herkel only teaches the range 30,000-50,000 g/mol (Herkel, para. [0010]) and Wooster teaches that the Mn range of 1,000-17,000 daltons is necessary to maintain a stable micelle made from amphiphilic copolymers. It would be obvious to an artisan to try the lower range of molecular weight polymers, particularly in view of the teachings of Wooster, to produce a stable micelle and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success leads to predictable results. As a result, there is a reasonable expectation of success in arriving at the invention of claim 25 in view of the teachings of Herkel and Wooster.
Double Patenting
The text of those sections of the MPEP relevant to nonstatutory double patenting not included in this section can be found above.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-9 of U.S. Patent No. 12,016,931 B2 in view of Herkel (European Patent Application Publication No. EP 2591801 A1, published on 15 May 2013, provided by Applicant in IDS filed on 22 February 2023).
Commonly assigned U.S. Patent No. 12,016,931 B2 has been described above.
The only difference between claims 1-3 and 5-9 of U.S. Patent No. ‘931 and instant claim 25 is that the claims of patent ‘931 do not recite the peptides to comprise at least one T cell epitope. This deficiency is offset by the teachings of Herkel.
Herkel has been described above.
It would have been prima facie obvious to a person of ordinary skill in the art at the time of filing of the instant application to either confirm the peptides recited by patent ‘931 comprise T cell epitopes or to substitute the peptides for ones that comprise at least one T cell epitope in view of the teachings of Herkel because Herkel teaches that autoimmune diseases may result from insufficient control of autoreactive lymphocytes (Herkel, para. [0002]). An artisan would reasonably expect that using peptides containing T cell epitopes linked to the exterior of the nanoparticles recited by patent ‘931 would have utility in treating autoimmune diseases, as taught by Herkel (Herkel, para. [0003-0004]). As a result, there is a reasonable expectation of success in arriving at the invention of instant claim 25 in view of claims 1-3 and 5-9 of U.S. Patent No. 12,016,931 B2 and the teachings of Herkel.
Claim 25 is directed to an invention not patentably distinct from claims 1-3 and 5-9 of commonly assigned U.S. Patent No. 12,016,931 B2 in view of Herkel. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 12,016,931 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(I) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
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 Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
