DETAILED CORRESPONDENCE
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 .
Response to Amendment
As to the amended specification and drawings filed on 2/13/26, the amendments are accepted and the previous objections to the drawings are withdrawn.
As to the amended claims filed on 2/13/26, the previous 112b rejections are withdrawn. However, new rejections are entered.
Based on the claim amendments are remarks filed on 2/13/26, the previous prior art rejection is withdrawn and a new rejection is set forth to address the claim amendments.
Information Disclosure Statement
For the sake of clarity of prosecution, the examiner reiterates the following paragraph regarding the information disclosure statement. Although the examiner appreciates applicants remarks on page 10 of their remarks filed on 2/13/26, the examiner maintains that there are many references listed in the specification that are not addressed by applicants remarks. Notably, due to the lack of information in the citations, the examiner reiterates that many of the potential citations could not be discerned.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The examiner notes the listing of US 9974839 in [16] of the instant specification, which is not listed on the IDS. The examiner also notes Sharma (2012), Huang (2017), de Vos (2014), Van Vlierberghe (2011), Stephan (2015), Andreasen (2003), Niggemann (1997), Applegate (1990), Gajewski (2013), Sheikh (2015), Veiseh (2015), Omer (2005), Paredes-Juarez (2014), Morch (2006) in [53, 54, 55, 57, 90] of the instant specification, which are not listed on the IDS. Many of these citations are not even full citations such that an actual journal could be searched or found. The examiner notes that these are just examples, and that there may be other instances of references not disclosed. Any references not listed on the IDS have not been considered unless cited on a PTO-892.
Claim Status
Claims 1-17 are pending with claims 1-8 being examined and claims 9-17 deemed withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what a “physiologically acceptable carrier” is describing. Applicants point to [36] of the specification when providing support for this amendment, but this section of the specification does not help describe applicants intent. The reason this limitation is unclear is because it is unclear what would or would not be “acceptable” since this is a subjective and relative term and it is unclear what would or would not be “acceptable” since there is no guidance relating what carriers are acceptable and what carriers are not acceptable (see MPEP 2173.05(b)). A potential infringer would not know whether any carrier would or would not read on the claim language. Further, it is unclear what the carrier is for. What is being carried by the carrier? Additionally, it is unclear how the carrier and the toroidal particles are related to each other.
Claims 2-8 are rejected based on further claim dependency.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3-6, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al (Sharma et al, “Toroidal-Spiral Particles for Codelivery of Anti-VEGFR-2 Antibody and Irinotecan: A potential implant to Hinder Recurrence of Glioblastoma Multiforme”; Biomolecules 15 (3): 756-762 (2014); hereinafter “Sharma”; already of record) in view of Brudno et al (US 20220354972; hereinafter “Brudno”; already of record).
As to claim 1, Sharma teaches an in situ molecule bioreactor and delivery system comprising a physiologically acceptable carrier and toroidal-spiral particles (Sharma teaches toroidal spiral particles that are used for treatment and delivery of cancer, including glioblastoma; p. 756-757, Fig. 1. Sharma teaches that the particles are placed into FACS or DMEM buffer/medium solutions, which the examiner is interpreting as physiologically acceptable since these buffer solutions are known to be used in cell culture or in cell-based experiments; p. 757-758), the toroidal-spiral particles comprising a biocompatible polymer matrix having an open channel and an internal compartment therein, wherein the internal compartment is operatively connected to said open channel, wherein said internal compartment encapsulates macromolecules suspended in a scaffold material that modulates activity or release of the macromolecules from the toroidal-spiral particles via the open channel and said internal compartment optionally comprises one or more active agents (Sharma teaches toroidal spiral particles that have a PEGDA polymer matrix and a channel formed with scaffold material of alginate encapsulating macromolecules; p. 756-757, Fig. 1. In as much as claimed and as best understood, Sharma teaches the compartment as part of the channel which includes the scaffold alginate encapsulating macromolecules such as antibodies, or the compartment as part of the polymer matrix PEGDA that includes small molecule drugs; p. 756-757, Fig. 1. The examiner notes that the compartment optionally comprises an active agent is not required).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Sharma does not specifically teach the alginate encapsulates cells thereby forming the cell bioreactor and delivery system. However, Brudno teaches the analogous art of molecular release for the treatment of cancer, including glioblastoma (Brudno; [1, 116]) which includes using a scaffold hydrogel material, such as alginate or collagen, to encapsulate and release molecules such as drugs, antibodies, and cells (Brudno teaches alginate hydrogel scaffold; [55, 119]. Brudno teaches that the hydrogel scaffold can include antibodies and chemotherapeutics; [5, 59, 115]. Brudno teaches that the hydrogel scaffold can encapsulate and release T-cells; [1, 52, 119, 125]. It would have been obvious to one of ordinary skill in the art to have modified the alginate hydrogel scaffold material that encapsulates molecules to treat cancer of Sharma to have been an alginate of collagen hydrogel that encapsulated cells as in Brudno because Brudno teaches that encapsulating cells with drugs enables the release of reprogramed cells to assist in the treatment of cancer (Brudno; [1, 116]) and also because Brudno teaches that encapsulating cells within a hyrdrogel is an obvious variant of encapsulating other molecules for the treatment of cancer (Brudno; [5, 52, 59, 115, 119, 125]). Additionally, Brudno teaches the need for using pharmaceutically acceptable carriers to prepare compositions that are safe and non-toxic (Brudno; [42, 91, 98]) and it would have been obvious to one of ordinary skill in the art to ensure that the delivery system for treating cancers of modified Sharma was used within an acceptable carrier as in Brudno because Brudno teaches the importance of using a safe and non-toxic carrier (Brudno; [42]) and that carriers are known to one of ordinary skill in the art in order to administed compositions to humans (Brudno; [98]).
As to claim 2, modified Sharma teaches the system of claim 1, wherein the biocompatible polymer matrix comprises polyethylene glycol diacrylate, polyethylene glycol methacrylate, gelatin methacryloyl, methacrylated hyaluronic acid, methacrylated chitosan, methacrylated chondroitin sulfate, methacrylated glycol chitosan, methacrylated alginate, methacrylated dextran, methacrylated gellan gum, methacrylated poly(ε-caprolactone), dimethacrylate poly-D,L-lactide, dextran hydroxyl ethyl methacrylate, dextran mono(2-acryloyloxyethyl) succinate, polyglycerol-co-sebacate acrylate, α,ω-diacrylate polyethylene carbonate, polytrimethylene carbonate methacrylate, polyglycerol-co-sebacate-cinnamate, polyethylene glycol methyl ether methylacrylate, ethylene glycol dimethacrylate, polypropylene glycol methacrylate, or combinations or copolymers thereof (Sharma teaches toroidal spiral particles that have a PEGDA matrix; p. 756-757, Fig. 1).
As to claim 3, modified Sharma teaches the system of claim 1, wherein the cells comprise immune cells, chimeric antigen receptor T cells, T cells engineered to express modified T cell receptors, stem cells, or islets of Langerhans (The modification of the alginate hydrogel scaffold material that encapsulates molecules to treat cancer of Sharma to have encapsulated cells as in Brudno has already been discussed above. Brudno teaches T-cells; [1, 52, 119, 125]).
As to claim 4, modified Sharma teaches the system of claim 1, wherein the scaffold material comprises collagen, alginate, chitosan, fibrin, keratin, polyacrylamide, polyethylene glycol, hyaluronic acid, or a combination thereof or copolymer thereof (Sharma teaches a channel formed with alginate encapsulating macromolecules; p. 756-757, Fig. 1).
As to claim 5, modified Sharma teaches the system of claim 1, wherein the one or more active agents comprise immune checkpoint antibodies, therapeutic proteins or peptides, cancer chemotherapeutic drugs, immunoregulators, cytokines, vitamins, nutrients, diagnostic contrast agents, quantum dots, polymeric nanoparticles, or lipid nanoparticles (In as much as claimed and as best understood, Sharma teaches the compartment as part of the channel which includes the scaffold alginate encapsulating macromolecules such as antibodies, or the compartment as part of the polymer matrix PEGDA that includes small molecule chemotherapeutic drugs; p. 756-757, Fig. 1. The examiner notes that the active agents are optional in claim 1 and are not required, and therefore what further defines the active agents does not further limit the system as claimed).
As to claim 6, modified Sharma teaches the system of claim 1, wherein the one or more active agents reside on a surface of the internal compartment, in the internal compartment, in the open channel, or a combination thereof (In as much as claimed and as best understood, Sharma teaches the compartment as part of the channel which includes the scaffold alginate encapsulating macromolecules such as antibodies, or the compartment as part of the polymer matrix PEGDA that includes small molecule drugs; p. 756-757, Fig. 1. The examiner notes that the active agents are optional in claim 1 and are not required, and therefore what further defines the active agents does not further limit the system as claimed).
As to claim 8, modified Sharma teaches the system of claim 1, wherein the cells comprise immune cells or chimeric antigen receptor T cells, the scaffold material comprises collagen, and the one or more active agents comprise IL-2 (The modification of the alginate hydrogel scaffold material that encapsulates molecules to treat cancer of Sharma to have been an alginate of collagen hydrogel that encapsulated cells as in Brudno has already been discussed above. Brudno teaches T-cells; [1, 52, 119, 125]. Brudno teaches collagen; [55, 125]. Brudno also teaches IL-2; [5]. The examiner notes that the active agents are optional in claim 1 and are not required, and therefore what further defines the active agents does not further limit the system as claimed).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al (Sharma et al, “Toroidal-Spiral Particles for Codelivery of Anti-VEGFR-2 Antibody and Irinotecan: A potential implant to Hinder Recurrence of Glioblastoma Multiforme”; Biomolecules 15 (3): 756-762 (2014); hereinafter “Sharma”; already of record) in view of Brudno et al (US 20220354972; hereinafter “Brudno”; already of record) in view of Vegas et al (Vegas et al. “Long-term glycemic control using polymer-encapsulated human stem cell–derived beta cells in immune-competent mice.” Nature Medicine, 22, pages 306-311 (2016); hereinafter “Vegas”; already of record).
As to claim 7, modified Sharma teaches the system of claim 1, where the scaffold material comprises alginate (Sharma teaches a channel formed with alginate encapsulating macromolecules; p. 756-757, Fig. 1) which encapsulates cells (The modification of the alginate hydrogel scaffold material that encapsulates molecules of Sharma to have been an alginate hydrogel that encapsulated cells as in Brudno has already been discussed above).
Modified Sharma does not specifically teach that the alginate scaffold material encapsulates islets of Langerhans cells. However, Vegas teaches the analogous art of treatment of disease in the body using alginate scaffold material that encapsulates islets of Langerhans cells (Vegas teaches beta cells encapsulated in alginate; p. 306, 308, 310). It would have been obvious to one of ordinary skill in the art to have modified the alginate hydrogel scaffold material that encapsulates cells to delivery and treatment of diseases in the body of modified Sharma to have been an alginate that encapsulated beta cells as in Vegas because Vegas teaches that it is common to attempt to treat diabetes by encapsulating islets into alginate (Vegas; p. 306, p. 310).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Orlando et al (US 20220305175; hereinafter “Orlando”; already of record) teaches islets encapsulated in alginate; [160].
Liu et al (Liu et a, “Heterogeneous polymeric particles encapsulating human T cells for Controlled Activation, Proliferation, and Delivery”, ACS Appl. Bio. Mater. 3: 7357-7362 (2020); hereinafter “Liu”; already of record) teaches encapsulation of cells, but is does not qualify as prior art. The examiner notes that this was submitted for publication on 8/8/20, and includes authors other than the instant inventor, but it was not published prior to the instant filling date and therefore does not qualify as prior art.
Plata et al (Plata et a, “Heterogeneous toroidal spiral particles for islet encapsulation”, Biomaterials Science 9: 3954-3967 (2021); hereinafter “Plata”; already of record) teaches encapsulation of cells, but is does not qualify as prior art.
Response to Arguments
Applicant’s arguments filed 2/13/26 have been considered, but are moot because they are towards the claim amendments and not the current grounds of rejection. However, because the examiner has relied on the same prior art references, then the Applicant's arguments have been fully considered but they are not persuasive.
Applicants argue on page 13 of their remarks that references Sharma and Brudno do not teach or suggest a physiological acceptable carrier. Applicants solely argue towards secondary reference Brudno and state that Brudno describes a process prior to being administered to a patient. However, the examiner respectfully disagrees. The examiner notes that the argued claim language is ambiguous and directs applicants attention to the 112(b) rejection above. Additionally, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Further, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Sharma teaches a physiologically acceptable carrier because Sharma teaches that the particles are placed into FACS or DMEM buffer/medium solutions, which the examiner is interpreting as physiologically acceptable since these buffer solutions are known to be used in cell culture or in cell-based experiments; p. 757-758. Also, Sharma teaches that the goal of the device is in vivo treatment of glioblastoma and hydrogels, thereby showing that the toroidal-spiral particles would need to be in some type of carrier in order to be preserved and then placed in the body; p 756, 761. It would have been obvious to one of ordinary skill in the art to have modified the alginate hydrogel scaffold material that encapsulates molecules to treat cancer of Sharma to have been an alginate of collagen hydrogel that encapsulated cells as in Brudno because Brudno teaches that encapsulating cells with drugs enables the release of reprogramed cells to assist in the treatment of cancer (Brudno; [1, 116]) and also because Brudno teaches that encapsulating cells within a hyrdrogel is an obvious variant of encapsulating other molecules for the treatment of cancer (Brudno; [5, 52, 59, 115, 119, 125]). This modification results in the treatment device of Sharma that aims to treat in vivo being configured to encapsulate cells instead of molecules as in Brudno. Additionally, it is the aim of Brudno to treat cancer which would take place in vivo (see Brudno figure 1) and would require a carrier. Additionally, Brudno teaches the need for using pharmaceutically acceptable carriers to prepare compositions that are safe and non-toxic (Brudno; [42, 91, 98]) and it would have been obvious to one of ordinary skill in the art to ensure that the delivery system for treating cancers of modified Sharma was used within an acceptable carrier as in Brudno because Brudno teaches the importance of using a safe and non-toxic carrier (Brudno; [42]) and that carriers are known to one of ordinary skill in the art in order to administed compositions to humans (Brudno; [98]).
Conclusion
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 BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798