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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 27, 2024 has been entered.
Applicants' arguments, filed September 27, 2024, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Specification
The disclosure is objected to because of the following informalities: trademarks such as TAXOL® and DESFERAL® are present in the specification as filed but are not properly formatted.
The trademarks should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
Claim 19 is 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.
Claim 19 contains the trademark/trade name TAXOL®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe paclitaxel and, accordingly, the identification/description is indefinite.
Please clarify.
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.
Claim(s) 1 – 10 and 12 – 36 were rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (WO 2010/019718). This rejection is MAINTAINED for the reasons of record set forth herein.
Davis et al. discloses carrier nanoparticles comprising a polymer containing a polyol coupled to a polymer containing a boronic acid (whole document, e.g., abstract). One or more compounds of interest can be carried by the nanoparticle, or attached to the polyol containing polymer and/or the boronic acid containing polymer (¶ [0008]). The polymer containing polyols comprises polymers of about 40,000 or less molecular weight (¶ [0055]). Example polymer structures are given at ¶ [0072]) with a structural unit of
PNG
media_image1.png
99
128
media_image1.png
Greyscale
being particularly relevant to the instant claims. Formula XI in ¶ [0082] contains two polyethylene glycol moieties with the sugar mucic acid, a vicinal diol, as one possible structure for structural unit A. Cationic moieties B can be used with anionic cargo (¶ [0086]) and formula XXIII at ¶ [0093] is amongst the specific structures specified for cationic B moieties. The polymer containing boronic acid can have formula
PNG
media_image2.png
163
299
media_image2.png
Greyscale
(¶ 00108]) which falls within the scope of instant claims. Targeting ligands can be attached to the nanoparticles with the choice of ligands depending on the type of delivery desired (e.g., ¶¶ [0068] - [0070]). Exemplary agents and targeted ligands are discussed in ¶ [00109] and include polynucleotides, polypeptides and proteins. Examples of the therapeutic agents include small molecule pharmaceuticals such as the chemotherapeutics doxorubicin and TAXOL®; antibiotics, steroids; or polynucleotides such as genomic DNA, cDNA and mRNA and can be covalently bound, such as through a biodegradable ester or disulfide linkage (¶ [00149]). In example 19, the small molecule drug camptothecin is linked to the mucic acid polymer via a biodegradable ester linkage (¶¶ [0063] and [00118]). Methods of administering a compound to an individual by the administration of an effective amount of nanoparticle with the compound comprised in the polyol containing polymer and/or the boronic acid containing polymer (¶ [0013]).
No specific examples of polymers that fall within the scope of the instant claims are exemplified.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare polymers as disclosed by Davis et al. of the –(AB)- structures disclosed by Davis using groups such as Formula XI and formula XXIII for A and B within the structural unit that can repeat in the polymers. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such elements are disclosed as part of the repeating structural unit –(AB)- that reads on the polymers of the instant claims and also comprises a boronic acid containing polymer segment. These materials can be made into nanoparticles that can have targeting agents attached and loaded with therapeutic agents such as the chemotherapeutics doxorubicin and TAXOL®, antibiotics, steroids, polynucleotides such as genomic DNA, cDNA and mRNA. The nanoparticles loaded with compounds can be administered to an individual and will address the need of such a subject for the compound delivered with the nanoparticles comprised of the polymeric materials disclosed by Davis et al.
Applicants traverse this rejection on the grounds that citation to formula XI ignores the clear language of claim 1 requiring the segment comprising at least one polyhydroxy linkage is cationically charged and this feature cannot be found in structure XI. Polymer 4 was also previously cited but the repeating unit structure of polymer 4 does not make it identical to the claimed polymers and does not contain an uncharged segment comprising a polyalkyeneglycol. As the claims require both a cationically charged segment and uncharged segment comprising a polyalkylene glycol, none of the compounds cited in Davis make obvious the claimed polymers.
These arguments are unpersuasive. Patentability is based on the structures encompassed by the claims and those disclosed by the prior art and not the specific wording or description in either. Polymers of the same structure can be defined using different structural or repeating units. The instant claims require a polymer with at least one structural unit of either -AB- or -BA-. Part A must comprise a polyalkylene glycol while part B has two parts whose order is not specified - a cationically charged segment, that will be called C, and a polyhydroxy linkage containing at least one pair of vicinal diols, that will be called D. This results in possible structural units for the instant claims of -ACD-, -ADC-, -CDA- and –DCA-. More than one such unit can be present and the different structural unit can be present as the claimed polymer comprises the claimed structural unit. Sequential charged and/or sequential uncharged segments can be present as long as at least one of -AB- or -BA- is present somewhere in the polymer. Turning to the prior art, the polymers containing polyols of Davis et al. can have structural units of –(A*B*)-, -(A*)-(B*)- or just -(A*)- (¶ [0072]; given the similar polymer descriptions in Davis et al. and the instant application, the Examiner has added the * to the letters of the prior art to better distinguish between the instant claims and the prior art). Formula XI is exemplified as one possibility for A*, which in the nomenclature of the instant claims above would be -A-D-A-. B* can be cationic such as Formula XXIII (¶¶ [0086] and [0093]), reading on the C portion of B of the instant claims.
PNG
media_image3.png
229
1265
media_image3.png
Greyscale
Despite the differences in how the structural/repeating units are defined in the instant claims and Davis et al., a polymer as disclosed in Davis et al. meets the limitations of the instant claims as shown by the boxed area above.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. as applied to claims 1 – 10 and 12 – 26 above, further in view of Davis et al. (WO 2014/133549, Davis’549, cited on IDS filed 8/20/21).
Davis et al. discloses the presence of boronic acid containing polymers but does not disclose the specific nitro containing boronic acid groups of claim 11.
Davis’549 discloses carrier nanoparticle comprising a polymer containing a polyol coupled to a polymer containing a boronic acid (whole document, e.g., abstract). Nanoparticles containing a nitrophenylboronic acid group have enhanced particle stability because of a reduced pKa (¶ [0017]). Structures of such groups are shown beginning at ¶ [0178] and while shown conjugated to the polyol polymer on p 45, those nitrophenylboronic acid groups have the same structure as the fragments recited in instant claim 11 with the nitro group ortho, meta or para to the boronic group.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a nitrophenylboronic acid group into the polymers of Davis et al. as the boronic acid containing moiety. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Davis’549 discloses that the presence of such groups lowers the pKa and enhances particle stability when the polymer is used to prepare a carrier nanoparticle. Both the polymers of Davis et al. and Davis’549 comprise polyol portions and can be attached in an analogous manner to alter the pKa to enhance particle stability.
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 – 36 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 37 of U.S. Patent No. 8,557,292 optionally further in view of Davis et al. (WO 2014/133549, Davis’549, cited on IDS filed 8/20/21). This rejection is MAINTAINED for the reasons set forth herein.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’292 recite nanoparticles containing a polyol and a boronic acid containing polymer with the boronic acid coupled to the polyol containing polymer via a reversible covalent linkage (claim 1) with structural units that can be as defined in claim 1 onward that fall within the scope of the instant claims. As shown in claims such as dependent claims 6, 8 and 9, mucic acid can be present in the claimed polymeric nanoparticles. Targeting and therapeutic agents, which read on biologically active agents, can be present (e.g., claims 20 – 24). The nanoparticles can be administered to a subject (claim 32), which when the nanoparticles also comprise a biologically active agent, will result in the delivery of the biologically active agent to the subject. Therefore the claims of US’292 are not patentably distinguished over the claims of the instant application as the same polymer structures are encompassed by the instant claims and the claims of US’292.
The boronic acid containing structure shown in claim 17 does not contain a nitro group as required by instant claim 11 but Davis’549, discussed above, discloses such structures and motivates their use due to the lower pKa imparted by the presence of such a group enhancing particle stability.
The arguments regarding this double patenting are the same as those addressed above regarding Davis et al. which were not persuasive for the reasons set forth above.
Claims 1 – 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 37 of U.S. Patent No. 9,913,911 optionally further in view of Davis et al. (WO 2014/133549, Davis’549, cited on IDS filed 8/20/21). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’911 recite a polyol polymer derived from the coupling of compound A with a compound of formula B as defined in claim 1 conjugated with a polymer containing a phenylboronic acid (claim 1). Formula A can contain mucic acid (claim 2) and formula B can be cationic (claim 3). The portion containing the phenylboronic acid can comprise polyethylene glycol (see R3 and R4 in claims 9 and 10). The polymer can be in nanoparticle form (claims 16 – 34) and can containing various therapeutic agents, reading on biologically active agents, and can comprise targeting ligands. The therapeutic agent can be delivered to a target (claims 35 – 37). Therefore the claims of US’911 are not patentably distinguished over the claims of the instant application as the same polymer structures are encompassed by the instant claims and the claims of US’911.
The phenylboronic acid groups do not contain a nitro group as required by instant claim 11 but Davis’549, discussed above, discloses such structures and motivates their use in the claimed polymers due to the lower pKa imparted by the presence of such a group enhancing polymeric nanoparticle stability.
Claims 1 – 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 26 of U.S. Patent No. 11,041,050. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’050 recite nanoparticles comprised of –[ABA]- or -[BAB]- wherein A is an uncharged polyalkylene glycol segment and B is a segment containing both a cationic charged moiety and at least one polyhydroxy linkage comprising at least one pair of vicinal diols; an encapsulated or covalently bound biologically active agent and can optionally comprising a boronic acid-containing structures of formula (X) (claim 1), which reads on the boron containing element of the instant claims. Dependent claims contain structures for these fragments (e.g., claims 3 – 6) that are the same as those of the instant claims. As RA can be nitro (claim 17), the structure of instant claim 11 is disclosed. The exemplified biological agents in claims 12 and 14 – 16 are the same as those of the instant claims and can be attached via a covalent bond that can be biodegradable (claim 13). While no methods of use are claimed, it would have been obvious to one of ordinary skill in the art to administer the biologically active agent containing nanoparticles to a subject in need of the biologically active agent as required by the instant claims.
Claims 1 – 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4- 10, 12 – 15 and 21 - 29 of copending Application No. 16/458,614 optionally further in view of Davis et al. (WO 2014/133549, Davis’549, cited on IDS filed 8/20/21). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’6124 recite nanoparticles comprised of a polymer of formula (I) – (III) as set forth in claim 1 with A being mucic acid; B can be cationic and can optionally contain a polyglycol –(CH2-CH2-O)20-200- that are covalently linked by amide or ester linkages; a targeting ligand attached via various specific bonds that are biodegradable and at least one therapeutic agent from the Markush group of claim 1 (claim 1). The nanoparticles can also be administered to human patient to treat a functional disorder (claims 25 – 29). Therefore the claims of US’614 are not patentably distinguished over the claims of the instant application as the same polymer structures are encompassed by the instant claims and the claims of US’614.
No boronic acid containing groups are claimed as being present in the claimed nanoparticles.
Davis’549 is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a nitrophenylboronic acid group into the polymers of US’614 as the boronic acid containing moiety. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Davis’549 discloses that the presence of such groups lowers the pKa and enhances particle stability when the polymer is used to prepare a carrier nanoparticle.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 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, Michael Hartley can be reached at 571-272-0616. 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.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618