DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Specification – Paragraph Numbering
There appears to be a discrepancy regarding paragraph numbering in the instant specification. This is at least because the instant specification lists a paragraph 00135 on pages 35-36 (of the copy of the specification filed on 31 October 2024) and a separate paragraph labeled paragraph 00135 on page 50 of the copy of the specification filed on 31 October 2024. This indicates that the paragraph numbering is non-consecutive. Paragraph numbering should be consecutive; appropriate correction is required.
Claim Interpretation
For the purposes of examination under prior art, the examiner understands a platelet membrane and a bacterial cell membrane to be within the scope of the required cellular membrane of part (b) of claim 1.
Claim Rejections - 35 USC § 102(b) (pre-AIA )
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3-6, and 8-9 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Huang et al. (US 2009/0274630 A1).
Huang et al. (hereafter referred to as Huang) is drawn to red blood cell derived vesicles, as of Huang, title and abstract, wherein said vesicles may encapsulate substances, as of Huang, title and abstract.
As to claim 1, the claim requires an outer surface derived from a membrane and an inner core of a non-cellular material. Huang appears to teach this as of page 3, paragraph 0040, relevant text reproduced below.
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The examiner notes that the above-reproduced text indicates that the red cell derived vesicles are cytoskeleton-free, indicating that there is an inner core comprising a non-cellular material. The outer surface appears to comprise red blood cell derived membrane.
As to claim 1, the claim further recites a releasable cargo. Huang teaches multiple different types of releasable cargo as of page 3, Table 2, reproduced below.
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As to claims 3-5, the composition of Huang appears to comprise an exterior made from the plasma membrane and/or the cellular membrane of red blood cells. This is understood to read on all of the requirements of claims 3-5.
As to claim 6, the agents in Table 2, reproduced above, read on the required therapeutic, diagnostic, or marker agents.
As to claims 8-9, the composition of Huang appears to be both a medicament delivery system as well as a pharmaceutical composition.
Claim Rejections - 35 USC § 103 – Obviousness
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-6 and 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huang et al. (US 2009/0274630 A1).
Huang et al. (hereafter referred to as Huang) is drawn to red blood cell derived vesicles, as of Huang, title and abstract, wherein said vesicles may encapsulate substances, as of Huang, title and abstract.
As to claim 1, the claim requires an outer surface derived from a membrane and an inner core of a non-cellular material. Huang appears to teach this as of page 3, paragraph 0040, relevant text reproduced in the anticipation rejection above. The red cell derived vesicles appear to be cytoskeleton-free, indicating that there is an inner core comprising a non-cellular material. The outer surface appears to comprise red blood cell derived membrane.
As to claim 1, the claim further recites a releasable cargo. Huang teaches multiple different types of releasable cargo as of page 3, Table 2, reproduced in the anticipation rejection above.
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner takes the position that Huang teaches all of the required elements, but not in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claims 3-5, the composition of Huang appears to comprise an exterior made from the plasma membrane and/or the cellular membrane of red blood cells. This is understood to read on all of the requirements of claims 3-5.
As to claim 6, the agents in Table 2, reproduced above, read on the required therapeutic, diagnostic, or marker agents.
As to claims 8-9, the composition of Huang appears to be both a medicament delivery system as well as a pharmaceutical composition.
This rejection does not apply to claim 2. Although Huang teaches poly-L-lysine in paragraph 0053, this appears to be used to grow the cells, and there is no evidence that the poly-L-lysine would have been present on the inside of the particle.
Claim 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huang et al. (US 2009/0274630 A1) in view of Capan et al. (Journal of Controlled Release, Vol. 60, 1999, pages 279-286) and Ferkol Jr. et al. (US Patent 5,972,901).
Huang is drawn to a red blood cell derived vesicle encapsulating an active agent that is non-cellular. See the rejections above over Huang by itself. Huang may encapsulate a nucleic acid, as of Huang, abstract.
Huang does not teach PLGA and/or polylysine.
Capan et al. (hereafter referred to as Capan) is drawn to a composition comprising PLGA microspheres encapsulating poly(L-lysine) complexed DNA, as of Capan, page 279, title and abstract. This complex appears to be used for increasing the transfection efficiency of the nucleic acid, as of Capan, page 280, left column, first full paragraph.
Capan does not teach a nanoparticle comprising a cell-derived membrane. Capan also does not appear to teach the benefits of complexing DNA with poly(L-lysine).
Ferkol Jr. et al. (hereafter referred toas Ferkol) is drawn to the administration of nucleic acids, as of Ferkol, title and abstract. Ferkol teaches the following, as of column 9, relevant text reproduced below.
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Also see the following text from Ferkol, column 9, lines 35-40, relevant text reproduced below.
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The examiner’s best understanding of this teaching is that Ferkol teaches that complexing DNA with poly(L-lysine) results in increased transfection, at least under certain routes of administration to certain tissue types.
It would have been prima facie obvious for one of ordinary skill in the art to have complexed the poly(L-lysine) of Capan with the nucleic acid of Huang. Huang is drawn to a nanoparticle for delivering a nucleic acid. Ferkol teaches that administration of a nucleic acid in combination with poly-L-lysine has advantages. As such, the skilled artisan would have been motivated to have combined the nucleic acid with the poly(L-lysine) of Capan to have predictably achieved various advantages such as increased transfection, as taught by Ferkol, with a reasonable expectation of success. The skilled artisan would have also been motivated to have included PLGA as this is taught by Ferkol to have been useful for the delivery of nucleic acids.
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huang et al. (US 2009/0274630 A1) in view of or as evidenced by Chambers et al. (Journal of Controlled Release, Vol. 100, 2004, pages 111-119).
Huang is drawn to a red blood cell derived vesicle encapsulating an active agent that is non-cellular. See the rejections above over Huang by itself.
Huang does not teach an increase in blood circulation half-life.
Chambers et al. (hereafter referred to as Chambers) is drawn to non-covalent adsorption of erythrocytes on polymeric nanoparticles to increase their circulation time, as of Chambers, page 111, title and abstract. See e.g. Chambers, page 115, left column, figure 2, reproduced below.
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Chambers appears to differ from the claimed invention because Chambers appears to teach intact red blood cells coating the polystyrene nanoparticles rather than membrane from red blood cells coating the polystyrene nanoparticle with the cytoplasm of the red blood cell having been removed.
The skilled artisan would have expected that the composition of Huang would have had prolonged circulation due to the presence of an erythrocyte membrane. Chambers indicates that erythrocyte coating of particles in the nano size range would have had substantial increases in circulation time. The composition taught by Huang is a nanoparticle coated by an erythrocyte membrane. The skilled artisan would have expected that, as the exterior of the nanoparticle of Huang is made from a membrane comprising the exterior of an erythrocyte, this exterior would have predictably delayed clearance from circulation in the manner taught by Chambers with a reasonable expectation of success.
Neither Huang nor Chambers explicitly compare the claimed composition to a PEG-coated composition. Nevertheless, there would have been a reasonable expectation that the composition of Huang would have had a circulation time in the claimed range. Something which is old (e.g. the composition of Huang) does not become patentable upon the discovery of a new property (e.g. that the composition has a half-life in the claimed range), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I & II). Additionally, once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the composition of Huang appears to be substantially identical to the claimed invention, at least at the exterior of the particle which would have presented to the immune system. Chambers provides evidence that the exterior of red blood cells significantly increases half-life in blood circulation, as explained above. This is understood to provide sufficient evidence or reasoning to shift the burden to applicant in accordance with MPEP 2112(V).
Claims 1-2, 6 and 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Albrecht et al. (US 2009/0214663 A1).
Albrecht et al. (hereafter referred to as Albrecht) is drawn to nanoparticles coated with a viral envelope, as of Albrecht, title, abstract, and figure 1, reproduced below.
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The above-reproduced figure shows the process of making a coated nanoparticle, and figure 1H, which is the final product, shows a particle coated with a viral envelope; said envelope appears to be a bilayer membrane. The skilled artisan would have motivated to have used this particle in a method of delivering an active agent such as an immunizing peptide, as of figure 13B, reproduced below.
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Also see the abstract of Albrecht, which teaches vaccines.
As to claim 1, the claim requires treating or preventing a disease or condition in a subject in need thereof. The skilled artisan would have understood that vaccines prevent conditions, and also treat conditions, e.g. in the case of cancer vaccines.
As to claim 1, part (a), Albrecht appears to teach a PLA/PLGA core as of paragraph 0088.
As to claim 1, part (b), the outer surface in Albrecht appears to be a membrane derived from a virus, as of at least figure 1H, reproduced above.
As to claim 1, Albrecht appears to teach all of the claimed requirements, but not together in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, Albrecht teaches PLA and PLGA, as explained above.
As to claim 6, Albrecht teaches antigens in paragraph 0046; these are understood to read on the required therapeutic or prophylactic agents.
As to claims 8-9, Albrecht teaches pharmaceutically acceptable carriers or vehicles in paragraph 0061; these read on the medicament delivery system in claim 8 and the pharmaceutically acceptable carrier or excipient in claim 9.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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.
Claims 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering to a subject a nanoparticle comprising an inner core of a non-cellular material and an outer surface comprising cellular material derived from a cell, does not reasonably provide enablement for treating or preventing the full scope of diseases and conditions by administering this. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As an initial matter, this rejection is specific to the options of claim 2 which are non-polar polymers; namely PLGA, PLA, and PGA. This rejection does not apply to the options of claim 2 reciting polylysine and polyglutamic acid as polylysine and polyglutamic acid are polar polymers having repeating ionic groups.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. See MPEP 2164.01(a). The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by MPEP 2164.01(a) and are set forth below.
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved; see MPEP 2164.03. Keeping that in mind, the factors set forth in MPEP 2164.01 are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative skill level (B)-(E)
The invention relates to a method of administering a composition comprising a non-cellular inner core coated with a cellular material. The relative skill of those in the art is high, that of an MD or PhD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Hu et al. (Proceedings of the National Academy of Sciences, Vol. 108 No. 27, July 5, 2011, pages 10980-10985). Hu et al. (hereafter referred to as Hu) appears to have been published slightly after the effective filing date of the instant application of 2 June 2011. Hu is drawn to a polymeric nanoparticle camouflaged by red blood cell membrane, as of Hu, page 10980, title and abstract and page 10981, figure 1, reproduced below.
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Hu teaches this for drug delivery generically, as of Hu, paragraph bridging pages 10983-10984, though the embodiment of Hu includes fluorescent dyes useful for fluorescent microscopy rather than therapeutic drugs, as of Hu, page 10982, figure 2.
The breadth of the claims (A)
The instant claims are broadly drawn to cores that are both derivatized with polar moieties and cores that are not derivatized with polar moieties. It does not appear that non-derivatized cores are properly enabled. This issue is discussed in greater detail in the section below entitled “5. Critical Unclaimed Feature:”
3. The amount of direction or guidance provided and the presence or absence of working examples (F)-(G)
Example 1, which begins on page 49 of the specification, appears to be drawn to a method of synthesis of a nanoparticle used in the method of claim 1. This may be loaded with DiD, as of page 53, paragraph 00144; the term “DiD” refers to a lipophilic indocarbocyanine fluorescent dye that is likely miscible with or soluble in the lipophilic PLGA core described in the instant application. The specification discloses an example of using the erythrocyte membrane coated particles to deliver doxorubicin, which is a known anti-cancer agent, to a cancer cell line, as of page 63, Example 2 of the instant specification. Example 3 is drawn to using erythrocyte membrane coated nanoparticles for delivery of personalized immunotherapy for cancer, as of page 78 of the instant application.
The specification provides no direction or guidance for practicing the claimed invention in its “full scope” because there would have been no reasonable expectation that the cellular material could have coated the full scope of PLGA, PGA, and PCL polymers. This is explained in the section below entitled “5. Critical Unclaimed Feature:”
4. The quantity of experimentation necessary (H)
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to have treated, cured, or prevented the full scope of diseases, especially in the absence of administration of a therapeutic agent, as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
5. Critical Unclaimed Feature:
A feature which is indicated as critical in a specification and is not recited in the claims should result in a rejection of such claim under the enablement provision section of 35 U.S.C. 112. See MPEP 2164.08(c). In this case, a charged and/or polar endgroup of the PLGA/PLA polymer recited by claim 2 would appear to be a critical feature that would need to be recited by the claim to render the claim enabled. The examiner presents the following arguments in support of this position.
As best understood by the examiner, the inner cores disclosed in the instant specification are charged. This is evidenced by the fact that said inner cores are carboxyl-terminated PLGA, as of the instant specification on pages 49-50, paragraph 00135, and carboxyl groups are negatively charged at neutral pH. The examiner presents the following rationale to explain why charged or polar groups on the surface of the inner core appear to be a critical feature rather than an optional feature.
The examiner takes the position that cell membranes in their native form in cells are generally in the form of lipid bilayers interspersed with membrane proteins. These bilayers have a hydrophilic headgroup facing the extracellular aqueous environment, a hydrophilic headgroup facing the interior intracellular environment, and a hydrophobic interior of the bilayer. See the following diagram drawn by the examiner.
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In contrast, the skilled artisan would not have expected this bilayer to have been able to have successfully coated a non-polar material were it to be in direct contact with the non-polar material. This is because, in view of the principle of like-dissolves-like, the skilled artisan would not have expected a non-polar material to have been able to have successfully interacted with the hydrophilic outside portion of the bilayer. This is because the outside portion of the bilayer is hydrophilic and engages in hydrogen bonds, ion-ion, ion-dipole, or dipole-dipole interactions, and this would not have been compatible with the van der Waals forces used by a non-polar polymer such as PLA or PLGA; this is essentially the same reason why oil and water are not miscible with each other. As such, the skilled artisan would not have expected the polar region of the interior lipid in the lipid bilayer to have been successfully able to have interacted with a non-polar polymer such as PLA or PLGA unless the non-polar polymer were derivatized to be charged or polar at its surface.
Further in support of this position, the examiner notes Albrecht et al. (US 2009/0241663 A1), over which the instant claims were rejected above. Albrecht teaches the following, as of paragraph 0043, reproduced below.
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The above-reproduced text would appear to indicate that charges surrounding the core particles of Albrecht are needed to achieve attachment to the membrane. In the absence of such charges, the hydrophobic surface of the core particle would not have been able to have attached to the hydrophilic end groups of the lipids making up the inner layer of the bilayer membrane.
As such, the presence of charges or polar moieties on the core particle to facilitate coating with the membrane appears to be a critical unclaimed feature that must be recited by the claims in order to render the claims properly enabled.
6. Properly Enabled Subject Matter:
Applicant may amend the claims to indicate that PLGA or PLA polymers are carboxy-terminated. This is because a carboxyl group (i.e. a C-(O)-OH group, which is also known as a carboxy group or a carboxylic acid group) would have been enabled for being able to non-covalently bind to cellular membrane. This is because the carboxyl group is a highly polar group, especially at neutral or basic pH under which conditions the carboxyl group would have been deprotonated and negatively charged and would have interacted electrostatically with positively charged species. Cell membranes comprise lipids which have polar endgroups. As such, the skilled artisan would have understood that in the case or carboxy-terminated PLA/PLGA, the polar carboxylic endgroups of PLA/PLGA would have interacted via ion-dipole or ion-ion interactions with the external polar groups of the lipids of the membrane, thereby resulting in the membrane being capable of coating the particle of non-cellular material via non-covalent interactions.
Non-Statutory 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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,098,839.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,632,070.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,007,147.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
Conflicting claim 1 of the ‘839 patent is drawn to a hydrogel comprising a nanoparticle comprising an inner core of a non-cellular material and an outer surface comprising a cellular material. Conflicting claim 6 recites various polymers which may comprise the inner core. Conflicting claim 13 recites a red blood cell membrane. Conflicting claim 16 recites a therapeutic, prophylactic, or other agent that is understood to read on the required releasable cargo. As such, the combination of all of these elements would result in a composition having all of the ingredients required by the instant claims, thereby resulting in a prima facie case of obviousness-type non-statutory double patenting.
The instant and conflicting claims differ because conflicting claim 1 recites a hydrogel, which is not required by the instant claims. Nevertheless, this is not understood to be sufficient to overcome this rejection because the instant claims do not exclude a hydrogel.
Regarding the ‘070 patent, these claims are drawn to a method of using a composition. However, this composition appears to have an inner core comprising a non-cellular material and an outer surface having a cellular membrane, as of conflicting claim 1, PLGA or other polymers in the inner core, as of conflicting claim 20, a red blood cell membrane as of conflicting claim 9, and a therapeutic or prophylactic agent, as of conflicting claim 33. As such, the instant claims are rejected over the claims of the ‘070 patent.
Regarding the ‘147 patent, conflicting claim 1 recites a nanoparticle having an inner core and an outer surface. Conflicting claim 6 recites a PLGA core, conflicting claim 13 recites a red blood cell membrane, and conflicting claim 16 recites a therapeutic agent.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,285,952.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims are drawn to a method of using a nanoparticle comprising an inner core made from a polymer such as PLGA along with a magnetic material, as of conflicting claim 1, and a red blood cell membrane, also as of conflicting claim 1. The examiner notes that a magnetic nanoparticle is a diagnostic agent because it is a T2 contrast agent in MRI, even if not used this way in the conflicting claims.
The instant and conflicting claims differ because the conflicting claims are drawn to a method for removal of a parasitic protozoan, which is not recited by the instant claims. Nevertheless, the composition used by the method of the conflicting claims appears to be the same as that required by the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,224,577.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,241,394.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims are drawn to a method utilizing a composition comprising a nanoparticle comprising an inner core of a non-cellular material, an outer surface comprising a platelet derived membrane, and an optional releasable cargo. The inner core may be PLGA, as of claim 10 of the ‘577 patent and claim 9 of the ‘394 patent.
The instant and conflicting claims differ because the conflicting claims are drawn to a particular method not recited by the instant claims. Nevertheless, the composition used in the method of the conflicting claims appears to have the same structure as that of the instant claims. This effectively anticipates the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This rejection applies to claims 3-4 because the examiner understands a platelet to be a type of blood cell.
Claims 1-5 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,610,493.
Claims 1-5 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,357,736.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims of both cases are drawn to a method of decreasing the effect of a toxin. The method entails administration of a nanoparticle comprising an inner core of a non-cellular material and an outer surface derived from a red blood cell membrane, as of conflicting claim 1 of both cases. The particle also comprises releasable cargo, as of conflicting claim 6 of the ‘736 patent and conflicting claim 6 of the ’493 patent.
The instant and conflicting claims differ because the conflicting claims are drawn to a method of neutralizing a toxin, which is not recited by the instant claims. Nevertheless, the subject matter of the conflicting claims appears to be drawn to a method of using the recited nanoparticle. This would therefore appear to effectively anticipate the claimed invention, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,000,593.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims are drawn to a nanostructure comprising an inner core of a non-cellular material and an outer surface comprising a cell membrane. The inner core may include PLGA and/or PCL as of conflicting claims 3 and 8, and the outer surface may include a membrane derived from a red blood cell, as of conflicting claims 1 and 15. The particle may have releasable cargo, as of conflicting claim 7.
The instant and conflicting claims differ because conflicting claim 1 specifies the cell type from which the membrane is derived, while this is not specified by instant claim 1. Nevertheless, the subject matter of conflicting claim 7 appears to be within the scope of that of instant claim 1, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
As to claim 6, although the conflicting claims do not explicitly recite a therapeutic agent, the skilled artisan would have been motivated to have combined a therapeutic agent with the subject matter of the conflicting claims because conflicting claim 12 is drawn to a method of treating a disease, and the skilled artisan would have been motivated to have added a therapeutic agent to have treated said disease.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,285,472.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims are drawn to a method for reducing anemia symptoms. This method entails administering a nanoparticle to a subject, wherein the nanoparticle comprises an inner core of a non-cellular material and an outer layer of a red blood cell membrane, as of conflicting claim 1. Conflicting claim 5 further recites a releasable cargo.
The instant and conflicting claims differ because the conflicting claims recite reducing anemia symptoms, which is not recited by the instant claims. Nevertheless, the method of the conflicting claims entails use of a particle with the same structure as that of the instant claims. As such, the subject matter of the conflicting claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
As to claim 6, although the conflicting claims do not explicitly recite a therapeutic agent, the skilled artisan would have been motivated to have combined a therapeutic agent with the subject matter of the conflicting claims because conflicting claim 1 is drawn to a method of treating a disease or symptom of a disease, and the skilled artisan would have been motivated to have added a therapeutic agent to have treated said disease.
Claims 1 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,588,867.
Claims 1 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,383,830.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims are drawn to a composition and method of using a composition comprising an inner core made of a non-cellular material and an outer surface made of a bacterial membrane. The composition of the conflicting claims or used in the method of the conflicting claims is taught to be a vaccine, indicating that it has a vaccine active ingredient therein.
The instant and conflicting claims differ because the conflicting claims recite a bacterial membrane, which is not explicitly recited by the instant claims. Nevertheless, a bacterial membrane is a type of cell membrane, reading on the requirement that the outer surface comprise a cellular membrane derived from a cell.
Claims 1 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,746,212.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The conflicting claims are drawn to a method of treating a tumor. The method entails administration of a particle comprising an inner core comprising a non-cellular material and an outer surface derived from a platelet membrane, as well as an anti-cancer therapeutic agent that is understood to read on the required releasable cargo. The inner core may be PLGA, PLA, and/or PGA, as of conflicting claim 4.
The instant and conflicting claims differ because the conflicting claims are drawn to a method of treating a tumor, which is not recited by the instant claims. Nevertheless, the subject matter of the conflicting claims is drawn to administration of a particle that is within the scope of that of the instant claims. As such, the subject matter of the conflicting claims effectively anticipates that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/582,123 (reference application – currently allowed but not yet issued). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The copending claims are drawn to a method of treating a disease or condition. This method entails administering a composition comprising an inner core made from a non-cellular material such as PLGA, an outer surface derived from a cell, and a releasable cargo for treating said disease or condition.
The instant and copending claims differ because the copending claims are drawn to a method for treating a disease, whereas the instant claims are drawn to a composition. Nevertheless, the composition used in the method of the copending claims appears to have all of the elements of the composition recited by the instant claims. As such, the composition of the copending claims effectively anticipates that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/814,200 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
Copending claim 1 is drawn to a nanoparticle comprising an inner core comprising a non-cellular material and an outer surface comprising a cellular material derived from a cell or membrane of a virus. Copending claim 5 further recites a releasable cargo.
The instant and copending claims differ because instant claim 1 requires a releasable cargo, which is not required by copending claim 1. Nevertheless, the subject matter of copending claim 5 appears to require all of the elements required by the instant claims. As such, the subject matter of copending claim 5 appears to effectively anticipate the instantly claimed invention, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/814,271 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising an interior of a non-cellular material, an outer surface comprising a cellular membrane which may be a red blood cell membrane, and a releasable cargo.
The copending claims are drawn to a pharmaceutical composition for treating or preventing an infectious, which may be a vaccine as of copending claim 3. The composition has an inner core comprising a non-cellular material and an outer surface comprising a cell or plasma membrane. The composition would also appear to have a vaccine active ingredient, which would read on the required releasable cargo.
The instant and copending claims differ because the copending claims appear to be limited to a composition for treating and preventing an infectious disease, whereas the instant claims are not limited in this manner. Nevertheless, the subject matter of the copending claims appears to be within the scope of that of the instant claims. This results in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
