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 .
Claim Status
Applicant’s amendments and remarks, filed 02/06/2026, are acknowledged.
Claims 2-3, 8-11, 14, 18, 22-27, 30-31, 34-40, 44-55, 61-64, 68, and 70-74 are canceled.
Claims 1, 4-5, 7, 12-13, 15, 17, 19, 32, 41-43, 59, 66-67, and 69 are amended.
Claims 1, 4-7, 12-13, 15-17, 19-21, 28-29, 32-33, 41-43, 56-60, 65-67, and 69 are pending.
Claims 20-21, 32-33, 41, 43, 56-60, 65-67, and 69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/10/2025.
As such, claims 1, 4-7, 12-13, 15-17, 19, 28-29, and 42 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The objections to the drawings are withdrawn in part. Specifically, issues regarding Figs. 13C, 62A, 62B, and 65C have been sufficiently addressed through amendments to the specification or drawings on 02/06/2026.
The nucleic acid and amino acid sequence disclosure objection is withdrawn. The issue of the specification missing the incorporation by reference paragraph has been sufficiently addressed through amendments to the specification on 02/06/2026.
The specification objections are withdrawn in part. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 02/06/2026.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 02/06/2026.
Withdrawn Rejections
Applicant’s arguments, see pages 13 and 14, filed 02/06/2026, with respect to claims 1-7, 9, 11-19, 28, 29, 37, and 42 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive in part. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 2-3, 9, 11, 14, 18, and 37 are canceled thus rendering the rejection moot. As such, the above rejections under 35 USC 112(b) are withdrawn.
The rejection of claims 1-7, 9, 11-15, 18-19, and 28-29 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ali et al (US 2017/0042995 A1, publication date: 02/16/2017) as evidenced by Shriver et al (Handb Exp Pharmacol. 2012 ; (207): 159–176); the rejection of claims 1-7, 9, 11, 13-19, and 28-29 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mooney et al (US 2019/0216910 A1, publication date: 07/18/2019) as evidenced by Shriver et al (Handb Exp Pharmacol. 2012 ; (207): 159–176); and, the rejection of claims 1-7, 9, 11-16, 18, 28-29, 37, and 42 under 35 USC 102 as allegedly being anticipated by Stephan (US 2016/0008399 A1, publication date: 01/14/2016) are modified in favor of the new limitations added in the amendment filed 02/06/2026. Specifically, Examiner acknowledges that claim 13 was amended to recite “the porous scaffold of claim 1, wherein the at least one compound that inhibits induction of regulatory T cells is released by controlled degradation from the scaffold” and claim 42 was amended to recite “the porous scaffold of claim 1, wherein the T cell immunostimulatory compound is IL-2 bound to silica-heparin microparticles in an alginate-RGD polymer, the at least one compound that inhibits induction of Tregs is loaded in one or more PLGA nanoparticles, and the porous scaffold further comprises anti-CD3 and anti-CD28 antibodies covalently bound to said alginate-RGD polymer”. Further, Examiner acknowledges that claims 2-3, 9, 11, 14, 18, and 37 are canceled thus rendering the rejection moot. Applicant’s arguments, see pages 18 and 19, filed 02/06/2026, with respect to the claims rejected under 35 USC 102 have been fully considered.
Maintained Objections
Drawings
The drawings are objected to because the specification references colors in the figures (e.g., see [049]), however, no color drawings are submitted. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant’s Arguments
Applicant respectfully requests withdrawal of the objections. See page 12 of the Remarks filed on 02/06/2026.
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. As stated above, Examiner acknowledges the amendments to Figs. 13C, 62A, 62B, and 65C. However, Applicant has made no arguments regarding the specification referencing colors in the figures (see [049]) nor has the specification been amended to remove the language. As such, the drawing objection is maintained.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see [309], [311], [337], and [338]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant’s Arguments
Applicant asserts that the embedded hyperlinks were amended to domain names without prefix. See page 13 of the Remarks filed on 02/06/2026.
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. Examiner acknowledges the amendments to the specification to remove the prefix of the hyperlinks; however, the hyperlinks are still browser-executable because they comprise “http” and/or “www.”. As such, Examiner suggests amending the specification to remove the prefixes “http” and “www” to overcome this objection.
Claim Rejections - 35 USC § 112(a) Written Description
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 1, 4-7, 12-13, 15-17, 19, 28, 29, and 42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claim 1 is drawn to a synthetic, biocompatible or biodegradable porous scaffold comprising: (a) at least one T cell immunostimulatory compound; and (b) at least one compound that inhibits induction of regulatory T cells (Tregs).
Claim 4 is drawn to the porous scaffold of claim 1, wherein the T cell immunostimulatory compound comprises a T cell activator, a T cell attractant or a T cell adhesion compound.
Claim 5 is drawn to the porous scaffold of claim 1, wherein the T cell immunostimulatory compound comprises a cytokine or an anti-cluster of differentiation (anti-CD) antibody or fragment thereof.
Claim 6 is drawn to the porous scaffold of claim 5, wherein the cytokine comprises an interleukin.
Claim 7 is drawn to the porous scaffold of claim 1, wherein the T cell immunostimulatory compound comprises interleukin-2 (IL-2) or IL-2 superkine.
Claim 12 is drawn to the porous scaffold of claim 1, wherein the T cell immunostimulatory compound comprises anti-CD3 antibodies or anti-CD28 antibodies, or the combination thereof.
Claim 13 is drawn to the porous scaffold of claim 1, wherein the at least one compound that inhibits induction of regulatory T cells is released by controlled degradation from the scaffold.
Claim 15 is drawn to the porous scaffold of claim 1, wherein the compound that inhibits induction of regulatory T cells is an inhibitor of transforming growth factor-beta (TGF-β).
Claim 16 is drawn to the porous scaffold of claim 15, wherein the inhibitor of TGF-β is a TGF-β receptor inhibitor.
Claim 17 is drawn to the porous scaffold of claim 15, wherein the inhibitor of TGF-β is galunisertib (LY2157299) or SB505124.
Claim 19 is drawn to the porous scaffold of claim 1, wherein the at least one T cell immunostimulatory compound is bound to heparin.
Claim 28 is drawn to the porous scaffold of claim 1, further comprising one or more nanoparticles.
Claim 29 is drawn to the porous scaffold of claim 28, wherein the one or more nanoparticles comprise poly(lactic-co-glycolic acid) (PLGA).
Claim 42 is drawn to the porous scaffold of claim 1, wherein the T cell immunostimulatory compound is IL-2 bound to silica-heparin microparticles in an alginate-RGD polymer, the at least one compound that inhibits induction of Tregs is loaded in one or more PLGA nanoparticles, and the porous scaffold further comprises anti-CD3 and anti-CD28 antibodies covalently bound to said alginate-RGD polymer.
The specification discloses of production of scaffolds with immunostimulatory and immunosuppression capabilities and methods of use (see Examples 1 and 2). The specification discloses that monodisperse mesoporous silica microparticles were formed using a microfluidic jet spray-drying route, using CTAB and/or Pluronic F127 as templating agents and TEOS for silica (see [299]). EDC/NHS was utilized to modify silica conjugates with heparin after treating the silica with APTES to provide primary amine groups (see [299]). For the preparation of antibody-conjugated microparticles, anti-CD3 (clone 2C11) and anti-CD28 (clone 37.51) were covalently conjugated to the surface of particles using carbodiimide chemistry (see [300]). The specification also discloses of forming scaffolds comprising oxidizing alginate with sodium periodate and covalently conjugated to RGD-containing peptide (see [301]). To immobilize anti-CD3 and anti-CD28 scaffolds, the scaffolds were activated with EDC/NHS or EDC/sulfo-NHS (see [305]). To prepare IL-2 loaded aAPCs, microparticles were incubated with cytokine in PBS buffer containing bovine serum albumin (see [306]). In vitro release of IL-2 from aAPCs or from aAPCs-loaded scaffolds as well as chemokine (C-C motif) ligand 21 (CCL21) release from the scaffolds were studied by incubating microparticles or one scaffolds (see [307]). Galunisertib (LY2157299) loaded PLGA nanoparticles were prepared using a nanoprecipitation method (see [308]). To load these nanoparticles into alginate-based scaffolds, LY2157299-loaded PLGA nanoparticles were mixed with alginate prior to crosslinking via calcium (see [308]).
To test the capacity of the heparin-conjugated particles, IL-2 was loaded (see [320]). Heparin modification delayed the release kinetics significantly, and the resulting relative diffusion constant was 10-fold less for the heparin conjugated particles than those of silica alone (see Figure 1E). Testing of degradation of anti-CD3 and anti-CD28 enhanced silica microparticles demonstrated that the particles’ masses are lost over 15-20 days (see Figure 1F). Example 12 demonstrates that IL-2 loaded silica-heparin particles are potent aAPCs for in vitro T cell expansion. Example 18 demonstrates that localized delivery in vitro of immunostimulants in 3D scaffolds. The specification discloses that at 1 nM concentrations, LY2157299 was found to be about twice as potent as SB505124 (a TGF-beta receptor inhibitor) in suppressing Treg formation (see [338]). Due to the hydrophobic nature of LY2157299, PLGA was selected as a carrier to load and release the selected TGF-beta inhibitors because PLGA renders a slow, controlled biodegradation due to its compact structure (see [339]). Treg formation was suppressed by about 40% via both soluble administration of TGF-beta inhibitors or upon co-culture with TGF-beta inhibitors releasing PLGA nanoparticles (see [339]). Example 19 demonstrates that particles with LY2157299 were loaded within the 3D scaffolds along with IL-2 releasing silica-heparin microparticles and PLGA-loaded TGF-beta inhibitor had a superior suppressive effect compared with its soluble administration (see Figure 15D).
However, the specification fails to disclose that Applicant was in possession of the large genera of scaffolds as claimed. Specifically, the specification fails to disclose that Applicant was in possession of a synthetic porous scaffold wherein the scaffold comprises any compound that regulates T cell immune response and any compound that regulates induction of Tregs. The specification also fails to disclose that Applicant was in possession of the claimed scaffolds wherein the T cell immunostimulatory compound comprises any of the compounds recited in claims 5-7 and 11; excluding IL-2, TGF-beta, and CCL21.
Although the specification discloses of antibody-conjugated silica microparticles comprising anti-CD3 and anti-CD28 antibodies loaded with IL-2 and PLGA-loaded TGF-beta inhibitor (LY2157299 or SB505124) nanoparticles, the claims are not limited to these scaffolds, and are inclusive of any porous scaffolds comprising any compound that regulates T cell immune response and any compound that regulates induction of Tregs. This indicates that there are hundreds, if not thousands, of possible scaffolds encompassed by the claims. However, the specification provides limited guidance on the structure and steps required for maintaining the claimed function(s). Therefore, the specification does not provide adequate written description to identify the broad and variable genus of scaffolds because, inter alia, the specification does not disclose a correlation between the necessary structure of the compounds and the function(s) recited in the claims; and thus, the specification does not distinguish the claimed genus from others, except by function. Although the term antibody does impart some structure, the structure that is common to antibodies is generally unrelated to its specific binding function; therefore, correlation is less likely for antibodies than for other molecules. Accordingly, the specification does not define any structural features commonly possessed by the members of the genus, because while the description of an ability of the claimed substance may generically describe the molecule’s function, it does not describe the substance itself. A definition by function does not suffice to define the genus because it is only an indication of what the substance does, rather than what it is; therefore, it is only a definition of a useful result rather than a definition of what achieves the result. In addition, because the genus of substances is highly variable (i.e. each substance would necessarily have a unique structure, See MPEP 2434), the generic description of the substance is insufficient to describe the genus. Further, given the highly diverse nature of antibodies, particularly in CDRs, even one of skill in the art cannot envision the structure of an antibody by only knowing its binding characteristics. Thus, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing a potentially massive number of antibodies/compounds and variants thereof claimed only by a functional characteristic(s) and/or partial structure.
A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not sufficient identifying characteristics for written description purposes, even when accompanied by a method of obtaining the agent. The specification does not adequately describe the correlation between the chemical structure and function of the genus, such as structural domains or motifs that are essential and distinguish members of the genus from those excluded. Thus, the genus of antibodies has no correlation between their structure and function.
MPEP § 2163.03(V) states:
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. “Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Applicant has not shown possession of a representative number of species of scaffolds. The disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.") (MPEP 2163).
The instant claims do not fully describe the structure of the compound that regulates T cell immune response or the compound that regulates induction of Tregs to achieve the required function. Accordingly, the specification also does not provide adequate written description to identify the broad genus of scaffolds, claimed only by a function characteristic(s) and not structures per se, because inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the claimed genus. Consequently, based on the lack of information within the specification, there is evidence that a representative number and a representative variety of the numerous scaffolds had not yet been identified and thus, the specification represents little more than a wish for possession. Therefore, one of skill in the art would not conclude that Applicant was in possession of the broad and highly variable genus of scaffolds claimed only by a partial structure and functional characteristic(s). Thus, the scaffolds described by the instant claims encompasses an overly broad genus, the structure of the compounds, and the functional outcome.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361). An adequate written description must contain enough information about the actual makeup of the claimed products — “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361). Most significant to the present case, the Court held that "knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies" (Amgen at 1361). The idea that written description of an antibody can be satisfied by the disclosure of a newly-characterized antigen “flouts basic legal principles of the written description requirement” as it “allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen... And Congress has not created a special written description requirement for antibodies” (Amgen at page 1362).
Abbvie v. Centocor (Fed. Cir. 2014) is also relevant to the instant claims. In Abbvie, the Court held that a disclosure of many different antibodies was not enough to support the genus of all neutralizing antibodies because the disclosed antibodies were very closely related to each other in structure and were not representative of the full diversity of the genus. The Court further noted that functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support especially in technology fields that are highly unpredictable where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
The instant case has many similarities to AbbVie above. First, the claims clearly attempt to define the genus of scaffold compounds by the functions of regulating T cell immune response and regulating induction of Tregs. As noted by AbbVie above, functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description. Second, there is no information in the specification based upon which one of skill in the art would conclude that the disclosed species for which applicant has identified as having the recited functions would be representative of the entire genus. The specification discloses no structure to correlate with the function. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim.
Furthermore, regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Further, the skilled artisan cannot envision the detailed chemical structure of the encompassed scaffold compounds, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ... To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
Regarding the encompassed scaffold compounds that are antibodies, the functional characteristics of antibodies (including binding specificity and affinity are dictated on their structure. Amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. For example, Vajdos et al. (J Mol Biol. 2002 Jul 5;320(2):415-28 at 416; previously submitted with the Office Action mailed 08/26/2025) teaches that, “ … Even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding. Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. As an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site." The art shows an unpredictable effect when making single versus multiple changes to any given CDR. For example, Brown et al. (J Immunol. 1996 May;156(9):3285-91 at 3290 and Tables 1 and 2; previously submitted with the Office Action mailed 08/26/2025), describes how the VH CDR2 of a particular antibody was generally tolerant of single amino acid changes, however the antibody lost binding upon introduction of two amino changes in the same region.
The claims encompass an extremely large number of possible compounds that have specific required functions. In the instant application, neither the art nor the specification provides a sufficient representative number of antibodies/compounds or a sufficient structure-function correlation to meet the written description requirements.
Regarding the encompassed scaffold compounds that are proteins and peptides, protein chemistry is one of the most unpredictable areas of biotechnology. This unpredictability prevents prediction of the effects that a given number or location of mutation will have on a protein (such as TNF or a cytokine) as taught by Skolnick et al. (Trends Biotechnol. 2000 Jan;18(1):34-9; previously submitted with the Office Action mailed 08/26/2025), sequence-based methods for predicting protein function are inadequate because of the multifunctional nature of proteins (see e.g. abstract). Further, just knowing the structure of the protein is also insufficient for prediction of functional sites (see e.g. abstract). Sequence to function methods cannot specifically identify complexities for proteins, such as gain and loss of function during evolution, or multiple functions possible within a cell (see e.g. page 34, right column). Skolnick advocates determining the structure of the protein, then identifying the functionally important residues since using the chemical structure to identify functional sites is more in line with how a protein actually works (see e.g. page 34, right column).
The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al. (J. Cell Biol. 111:2129-2138, 1990; previously submitted with the Office Action mailed 08/26/2025) who teach that replacement of a single lysine residue at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Lazar et al. (Mol. Cell. Biol., 8:1247-1252, 1988; previously submitted with the Office Action mailed 08/26/2025) who teach that in transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen. These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein.
Further, Miosge (Proc Natl Acad Sci U S A. 2015 Sep 15;112(37):E5189-98; previously submitted with the Office Action mailed 08/26/2025) teach that Short of mutational studies of all possible amino acid substitutions for a protein, coupled with comprehensive functional assays, the sheer number and diversity of missense mutations that are possible for proteins means that their functional importance must presently be addressed primarily by computational inference (see e.g. page E5189, left column). However, in a study examining some of these methods, Miosge shows that there is potential for incorrect calling of mutations (see e.g. page E5196, left column, top paragraph). The authors conclude that the discordance between predicted and actual effect of missense mutations creates the potential for many false conclusions in clinical settings where sequencing is performed to detect disease-causing mutations (see e.g. page E5195, right column, last paragraph). The findings in their study show underscore the importance of interpreting variation by direct experimental measurement of the consequences of a candidate mutation, using as sensitive and specific an assay as possible (see e.g. page E5197, left column, top paragraph). Additionally, Bork (Genome Research, 2000,10:398-400; previously submitted with the Office Action mailed 08/26/2025) clearly teaches the pitfalls associated with comparative sequence analysis for predicting protein function because of the known error margins for high-throughput computational methods. Bork specifically teaches that computational sequence analysis is far from perfect, despite the fact that sequencing itself is highly automated and accurate (p. 398, column 1). One of the reasons for the inaccuracy is that the quality of data in public sequence databases is still insufficient. This is particularly true for data on protein function. Protein function is context dependent, and both molecular and cellular aspects have to be considered (p. 398, column 2). Conclusions from the comparison analysis are often stretched with regard to protein products (p. 398, column 3). Further, although gene annotation via sequence database searches is already a routine job, even here the error rate is considerable (p. 399, column 2). Most features predicted with an accuracy of greater than 70% are of structural nature and, at best, only indirectly imply a certain functionality (see legend for table 1, page 399). As more sequences are added and as errors accumulate and propagate it becomes more difficult to infer correct function from the many possibilities revealed by database search (p. 399, paragraph bridging columns 2 and 3). The reference finally cautions that although the current methods seem to capture important features and explain general trends, 30% of those features are missing or predicted wrongly. This has to be kept in mind when processing the results further (p. 400, paragraph bridging cols 1 and 2).
One key issue is the prediction of protein function based on sequence similarity, which could be one way to identify the functional proteins that are useful in the instant claims. Kulmanov et al (Bioinformatics, 34(4), 2018, 660–668; previously submitted with the Office Action mailed 08/26/2025), teach that there are key challenges for protein function prediction methods (see e.g. page 661, left column). These challenges arise from the difficulty identifying and accounting for the complex relationship between protein sequence structure and function (see e.g. page 661, left column). Despite significant progress in the past years in protein structure prediction, it still requires large efforts to predict protein structure with sufficient quality to be useful in function prediction (see e.g. page 661, left column). Another challenge is that proteins do not function in isolation. In particular higher level physiological functions that go beyond simple molecular interactions will require other proteins and cannot usually be predicted by considering a single protein in isolation (see e.g. page 661, left column). Due to these challenges, it is not obvious what kinds of features should be used to predict the functions of a protein and whether they can be generated efficiently for a large number of proteins, such as the vast genus of proteins and peptides that may be encompassed by the instant claims (see e.g. page 661, left column).
The state of the art regarding the structure-function correlation cannot be relied upon because functional characteristics of any peptide/protein are determined by its structure as evidenced by Greenspan et al. 1999 (Defining epitopes: It's not as easy as it seems; Nature Biotechnology, 17:936-937; previously submitted with the Office Action mailed 08/26/2025). Greenspan et al. teach that as little as one substitution of an amino acid (e.g. alanine) in a sequence results in unpredictable changes in the 3-dimenstional structure of the new peptide sequence which, in turn, results in changes in the functional activity such as binding affinity of the peptide sequence (page 936, 1st column). Greenspan et al. teach that contribution of each residue (i.e. each amino acid) cannot be estimated with any confidence if the replacement affects the properties of the free form of the molecule (page 936, 3rd column).
Given not only the teachings of Skolnick et al., Lazar et al., Burgess et al., and Greenspan et al., but also the limitations and pitfalls of using computational sequence analysis and the unknown effects of alternative splicing, post translational modification and cellular context on protein function as taught by Bork, the claimed scaffold compounds could not be predicted based on sequence identity. Clearly, it could not be predicted that a polypeptide or a variant that shares only partial homology with a disclosed protein or that is a fragment of a given SEQ ID NO. will function in a given manner.
Regarding scaffold compounds that are small molecules of a particular protein target, the prediction of binding to a target, much less the inhibitory activity, is highly unpredictable. According to Guido et al. (Curr Med Chem. 2008;15(1):37-46; previously submitted with the Office Action mailed 08/26/2025), accurately predicting the binding affinity of new drug candidates remains a major challenge in drug discovery (see page 37). There are a vast number of possible compounds that may bind any particular target, many of which have likely not been discovered. Relying on virtual screening also lends unpredictability to the art regarding identification of molecules that would be capable of the required functions of the instant claims. Guido et al. teach that there are two main complex issues with predicting activity for a small molecule: accurate structural modeling and/or correct prediction of activity (see page 40). As taught by Clark et al. (J. Med. Chem., 2014, 57 (12), pp 5023–5038; previously submitted with the Office Action mailed 08/26/2025), even when guided by structural data, developing selective structure-activity relationships has been challenging owing to the similarities of the enzymes (see page 5028). Therefore, it is impossible for one of skill in the art to predict that any particular encompassed small molecule therapeutic would function to inhibit a particular protein, especially a particular protein family member, or treat disease.
Regarding scaffold compounds that are nucleic acid-based therapeutics, the efficacy of any possible DNA or RNA based therapeutic modality is highly unpredictable. This unpredictability stems from an inability to predict the effects of any particular sequence the expression or function of any target. As taught by Aagaard et al. (Advanced Drug Delivery Reviews 59 (2007) 75–86; previously submitted with the Office Action mailed 08/26/2025), the development of RNAi based therapeutics faces several challenges, including the need for controllable or moderate promoter systems and therapeutics that are efficient at low doses (see page 79), the ability of an unpredictable number of sequences to stimulate immune responses, such as type I interferon responses (see page 79), competition with cellular RNAi components (see page 83), the side effect of suppressing off targets (see page 80), and challenging delivery (see page 83). The success of antisense strategies, including anti-RNA and anti-DNA strategies are also highly unpredictable. Warzocha et al. (Leukemia and Lymphoma (1997) Vol. 24. pp. 267-281; previously submitted with the Office Action mailed 08/26/2025) teach that the efficacy of antisense effects varies between different targeted sites of RNA molecules and three-dimensional RNA structures (see page 269), while DNA-targeting strategies have numerous problems including a restricted number of DNA sequences that can form triple helices at appropriate positions within genes and the inaccessibility of particular sequences due to histones and other proteins (see page 269). These references demonstrate that variation in RNA or DNA based therapeutics will often dramatically affect the biological activity and characteristics of the intended therapeutic. McKeague et al. (J Nucleic Acids. 2012;2012:748913. Epub 2012 Oct 24; previously submitted with the Office Action mailed 08/26/2025) teach that aptamers have particular challenges because unlike antibodies or molecular imprinted polymers, their tertiary structure is highly dependent on solution conditions and they are easily degraded in blood. Further, they have less chemical diversity than other antagonist molecules (see page 2), and have issues associated with determining the Kd measurements for a given molecule (see page 13).
Given the teachings of Aagaard et al, Warzocha et al, and McKeague et al, the claimed nucleic acid therapeutics could not be predicted based on the targets selected or similarities to the disclosed example therapeutics. Therefore, it is impossible for one of skill in the art to predict that any particular encompassed nucleic acid based therapeutic, such as oligonucleotide aptamers, RNAi molecules and antisense oligonucleotides, would function to decrease expression or function of a target gene or protein, or treat disease.
The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function (see MPEP 2163). A patent specification must set forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed. In the case of DNA or proteins, an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention (see Lilly, 119 F.3d at 1566 (quoting Fiers, 984 F.2d 15 1171 ). Because the specification does not describe the amino acid sequences nor any core structures for potentially numerous different antibody amino acid sequences which would have the recited dissociation constant, one of skill in the art would reasonably conclude that applicant was not in possession of the claimed genus of all scaffolds.
A key role played by the written description requirement is to prevent “attempt[s] to preempt the future before it has arrived.” Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of antibodies that includes members not previously characterized or described could negatively impact the future development of species within the claimed genus of antibodies.
While “examples explicitly covering the full scope of the claim language” typically will not be required, a sufficient number of representative species must be included to “demonstrate that the patentee possessed the full scope of the [claimed] invention.” Lizard tech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724,1732 (Fed. Cir. 2005).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the claimed scaffolds. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features (see, Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916,927, 69 USPQ2d 1886, 1895 (Fed. Cir. 2004); accord Ex Parte Kubin, 2007-0819, BPAI 31 May 2007, opinion at p. 16, paragraph 1). The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116).
Without an adequate structural description of the claimed components and descriptive support on how to put them together, one of ordinary skill in the art would not be reasonably apprised that Applicant was in possession of the genus of recombinant proteins as claimed. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Applicant’s Arguments
Applicant traverses the rejection in light of the amendments to the claims (see page 15 of the Remarks filed on 02/06/2026). Applicant states that the claims have been amended to focus on immunostimulatory scaffolds that comprise both a T cell immunostimulatory compound and a compound that inhibits induction of Tregs. The specification describes various porous scaffold components that can comprise such an immunostimulatory scaffold and compounds comprised therein, description of selections of the individual compounds, and scaffold components comprising those compounds in sufficient identifying characteristics such as structure or physical properties, functional properties coupled with disclosed correlation between structure and function, or combinations thereof, to satisfy the written description requirement… Applicant asserts that sufficient guidance is provided in the specification to support the limited genus of scaffolds by compound and/or function in the amended claims. With regard to the T cell immunostimulatory compound contained therein, the specification contains sufficient teaching of the desired function of such compound and provides selections of immunostimulatory compounds (e.g., claim 7 before amendment herein) that suffice. With regard to compounds that inhibit induction of Tregs, the function of compounds described starting at paragraph [0214] for example, including TGF-3 receptor inhibitors and various examples provided (paragraph [0215]). Applicant asserts that sufficient description is provided for the selections of T cell immunostimulatory compounds and compounds that inhibit induction of Tregs, to support the claims as amended. Additional components of the porous scaffolds are similarly sufficiently described, for example, use of heparin to bind the T cell immunostimulatory compound (paragraph [0122]), as loading of the T cell immunostimulatory compound on silica microparticles is enhanced by heparin as well as providing controlled release (same paragraph). The selection of PLGA for loading the compound that inhibits induction of Tregs is described to enhance loading and release (paragraph [0339]) is merely an option of how the compound may be incorporated into the porous nanoparticles.
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. The claims describe components of the porous scaffold by function without providing a structure. While Applicant is entitled to use functional language in the description of claimed agents, according to MPEP 2163, an invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. This matches the facts here. The claims require specific functionality for the components of the porous scaffold, but the instant disclosure does not provide description of the corresponding structure for that functionality or a representative number of species for the agents/components. For example, the T cell immunostimulatory compound is defined by its binding specificity, and the compound that inhibits induction of Tregs are also defined by their ability to inhibit TGF-beta. In both the base claims and the dependent claims, for at least one agent/component in each claim, the claims only describe what the agent/component does, not what the agents/components are. While the agent/component of the porous scaffold that galunisertib or SV505124 is described as long as there are no additional functional requirements like those found in the dependent claims, the T cell immunostimulatory compound is not defined in any way, except for its functional properties. While methods to identify compounds with the required function may be routine in the art, the fact that any experimentation is required to figure out exactly what is encompassed necessarily means that applicant has not sufficiently described the claimed subject matter.
There are thousands of possible porous scaffolds encompassed by the instant claims. One of skill in the art could not immediately envisage the encompassed species in each genus from the guidance provided in the instant specification and claims. Applicant has supplied examples of components of the claimed porous scaffold, the claims are not limited to this species. The claims encompass all T cell immunostimulatory compounds, all compounds that inhibit induction of Tregs, any anti-CD3 antibody, and any anti-CD28 antibody. This encompasses an extremely broad genus of compounds with a specific function, for which no correlating structure is provided. While one of skill in the art could likely screen for said compounds and antibodies, the mere fact that experimentation is necessary to identify the members of the genus indicates that proper description has not been provided.
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). Describing a composition by its function alone typically will not suffice to sufficiently describe the composition. See Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene' s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product; however, the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").
Specifically addressing the anti-CD3 and anti-CD28 antibodies, the Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself even when preparation of such an antibody would be routine and conventional. Amgen Inc., v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). A key role played by the written description requirement is to prevent “attempt[s] to preempt the future before it has arrived.” Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of antibodies that includes members not previously characterized or described could negatively impact the future development of species within the claimed genus of antibodies. In the instant application, neither the art nor the specification provides a sufficient representative number of antibodies or a sufficient structure-function correlation to meet the written description requirements.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Further, arguments relating to the isolation of an antibody with specific characteristics may be more appropriately directed to the invention' s enablement, since the method of isolating would detail how to make the invention. However, the enablement of the invention has not been rejected by the Examiner.
Regarding the disclosed species, Applicant is attempting to read limitations into the claims that are not present. As indicated in MPEP 2145, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims are not limited to the porous scaffolds described in the arguments, and instead encompass a large genus of admixtures, for which the components are not adequately described.
As such, the written description rejection is maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Ali (US 2017/0042995 A1)
Claims 1, 4-7, 12, 13, 15, 19, and 28-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ali et al (US 2017/0042995 A1, publication date: 02/16/2017) as evidenced by Shriver et al (Handb Exp Pharmacol. 2012 ; (207): 159–176; previously submitted with the Office Action mailed 08/26/2025).
With respect to claims 1, 4-7, and 12, Ali et al disclose of compositions, methods, and devices for enhancing an endogenous immune response against cancer (see Abstract). Particularly, Ali et al disclose of a device comprising an inhibitor of an immune-inhibitory protein; a scaffold composition; a cell recruitment composition; and a bioactive composition wherein the bioactive composition is incorporated into or coated onto the scaffold composition, and wherein the bioactive composition causes modification of cells in or recruited to the device (see [0005]). Ali et al disclose that the immune-inhibitory protein (e.g., CTLA4 or PD1) enhances the immunosuppressive function of a Treg cell (see [0006]). The device contains a scaffold that comprises open, interconnected macropores comprising a deployment signal capable of inducing or promoting migration of cells wherein the deployment signal comprises a protein, peptide, or nucleic acid that depletes or diffuses of the cell recruitment composition comprising a cytokine, chemokine, or growth factor (see [0012]-[0013]). Examples of cytokines include IL-2 and IL-4 (see [0241] and [0280]).
With respect to claims 12 and 15, Ali et al disclose that growth factors encompassed by the composition include, but are not limited to, transforming growth factor beta (see [0241]).
With respect to claim 13, Ali et al disclose that the claimed scaffold comprises an alginate that control the rate of degradation of the scaffold (see [0249]).
With respect to instant claim 19, Ali et al disclose of immunostimulatory compounds comprising a TLR agonist wherein said agonist further comprises heparin sulfate or a fragment thereof (see [0047] and [0051]). While Ali et al does not explicitly recite heparin, it is known in the art that heparin sulfate contains all of the structural variations found in heparin as evidenced by Shriver et al (see pg. 3).
With respect to claims 28 and 29, Ali et al disclose that PLG (poly-lactide-co-glycolide) scaffolds were modified to present nanoparticles containing TLR-activating (see [0322]).
As such, the teachings of Ali et al anticipate the instant claims.
Mooney (US 2019/0216910 A1)
Claims 1, 4-7, 15-17, 19, and 28-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mooney et al (US 2019/0216910 A1, publication date: 07/18/2019) as evidenced by Shriver et al (Handb Exp Pharmacol. 2012 ; (207): 159–176).
With respect to instant claims 1 and 4-7, Mooney et al disclose of methods and compositions for eliciting an immune response to an antigen, such as cancer and microbial antigens (see Abstract). Particularly, Mooney et al disclose of a device comprising a delivery vehicle comprising a scaffold composition and any combination of one or more of the following compounds: (a) at least one antigen; (b) at least one immunostimulatory compound; (c) at least one compound that attracts an immune cell to or into the delivery vehicle; (d) at least one compound that induces immunogenic cell death of a tumor cell; (e) at least one compound that inhibits T-cell or dendritic cell suppression; and/or (f) at least one compound that inhibits an immune-inhibitory protein (see [0006]). Mooney et al also disclose that the claimed invention further comprises one or more of (i) an immunostimulatory compound, (ii) a compound that causes immunological cell death of a tumor cell, (iii) a compound that inhibits T cell or dendritic cell suppression, (iv) a compound that inhibits an immune-inhibitory protein, and (v) a cytokine (e.g., a chemoattractant of immune cells, such as dendritic cells) (see [0060]). Mooney et al disclose that the compound that inhibits T cell or dendritic cell suppression is a TGF-beta inhibitor (see [0061]). Mooney et al disclose that the scaffold comprises a cytokine comprises a cytokine such as GM-CSF, Flt3L, XCL1, IL-2, or IL-12 (see [0061]).
With respect to instant claims 15-17, Mooney et al disclose of immunostimulatory compounds being a TGF-beta inhibitor comprising LY2157299 (see [0051] and [0061]).
With respect to instant claim 19, Mooney et al disclose of immunostimulatory compounds comprising a TLR agonist wherein said agonist further comprises heparin sulfate or a fragment thereof (see [0043]). While Mooney et al does not explicitly recite heparin, it is known in the art that heparin sulfate contains all of the structural variations found in heparin as evidenced by Shriver et al (see pg. 3).
With respect to instant claims 28 and 29, Mooney et al disclose of the scaffolds comprise nanoparticles comprising PLGA (see [0036], [0054], and [0069]).
As such, the teachings of Mooney et al anticipate the instant claims.
Stephan (US 2016/0008399 A1)
Claims 1, 4-7, 12, 13, 15, 16, and 28-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stephan (US 2016/0008399 A1, publication date: 01/14/2016).
With respect to instant claims 1, 4-7, 12, 15, 16, and 28-29, Stephan discloses of compositions and methods for the delivery of immune cells to treat un-resectable or non-resected tumor cells and tumor relapse; the compositions comprise (i) a structure comprising an injectable polymer or scaffold comprising pores; (ii) lymphocytes disposed within the structure, (iii) at least one lymphocyte-adhesion moiety associated with the structure; and (iv) at least one lymphocyte-activating moiety associated with the structure, and optionally an immune stimulant (see Abstract). Particularly, Stephan discloses that the lymphocytes are T-cells, specifically CD8+ T cells (see [0007]). Stephan discloses that the lymphocyte-activating moieties are bound to or incorporated in one or more particles, wherein the particles are microparticles or nanoparticles (see [0009], [0087], and [0171]). Stephan discloses that the particles can be included within injectable structures and/or within scaffolds, and can be formed from any biocompatible polymer including PLGA (see [0048] and [0086]). Stephan discloses that the immune stimulant can be a cytokine, an antibody, a small molecule, an siRNA, a plasmid DNA , and/or a vaccine adjuvant; wherein the cytokine is IL-2, IL-4, IL-10, IL-11, IL-12, IL-15, IL-18, TNF-alpha, IFN-alpha, IFN-beta, IFN-gamma, or GM-CSF (see [0011], [0079], and [0080]). Stephan discloses that the small molecule drugs include TGF-beta inhibitors (see [0081]).
With respect to instant claim 13, Stephan discloses that the composition control releases tumor fighting lymphocytes (see [0021]).
As such, the teachings of Stephan anticipate the present invention.
Applicant’s Arguments
Applicant respectfully traverses the 102 rejections (see pages 16-19 of the Remarks filed on 02/06/2026).
While Ali's compositions, methods and devices include a bioactive composition which is defined in Ali as among many different components, in one aspect, the bioactive composition is described as at least a tumor antigen, tumor cell lysate, irradiated tumor cells, or other antigen (e.g., paragraphs [0093] and [0096]; moreover, all examples in Ali pertain to a "PLG Vaccine" that includes a tumor component. Ali references US Patent 8,067,237 for compositions and methods of making their instantly described vaccine; the '237 patent describes antigens incorporated into the polymer. Such incorporated antigens recruit dendritic cells (e.g., paragraph [0074]). In contrast, Applicant discovered that a scaffold comprising an immunostimulatory component and an inhibitor of induction of Tregs could recruit immune cells from a tumor and enhance their tumor killing activity, without the need to include a tumor antigen in the scaffold. Furthermore, Ali states in paragraph [0380]: "These data suggest that the tumor inhibition induced by combining vaccination with blockade treatments is likely due to enhanced T cell activation and cytotoxicity as opposed to blocking the immune suppression mediated by Tregs as reported elsewhere." Applicant's scaffold is not a vaccine; it enhances the tumoricidal activity of immune cells already targeting the tumor.
Applicant asserts that Mooney's methods and compositions require the presence of an antigen in the scaffold (as well as polyethyleneimine [PEI], bound or unbound thereto); all examples include such antigen. In the absence of antigen, Mooney's scaffolds are ineffective (e.g., Example 2, Figure 21C), as are scaffolds with antigen alone, without PEI (Fig. 20C). As with Ali, Mooney's scaffolds incorporate antigen to recruit dendritic cells; in contrast, Applicant's scaffolds recruit and activate immune cells. Mooney does not disclose a composition comprising both a T cell immunostimulatory compound and a compound that inhibits induction of Tregs; while description of these components is provided individually, at the core, only a composition comprising antigen with PEI is provided.
Stephan's scaffolds comprise tumor-reactive T lymphocytes, whereas Applicant's scaffolds recruit immune cells, e.g., from a tumor, and do not comprise tumor-reactive T lymphocytes. Furthermore, Stephan does not disclose a scaffold comprising including a compound that inhibits induction of Tregs in its composition; inhibitors of TGF-beta are mentioned among a litany of exemplary small molecule drugs, without ascribing a function or as a component of the scaffold; small molecules are included among immune stimulants.
Response to Arguments
Applicant's arguments filed 2/06/2026 have been fully considered but they are not persuasive.
Applicant is reminded that the instant claims recite the transitional phrase “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). In the instant case, the composition requires specific components which are all described within the Ali reference. MPEP 2131.02 states that when the species is clearly named in a reference, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). Ali discloses of a composition comprising a scaffold which comprises the elements recited in the instant claims such as the immune-inhibitory protein (e.g., CTLA4 or PD1) enhances the immunosuppressive function of a Treg cell (see [0006]); a protein, peptide, or nucleic acid that depletes or diffuses of the cell recruitment composition comprising a cytokine, chemokine, or growth factor (see [0012]-[0013]). Examples of cytokines include IL-2 and IL-4 (see [0241] and [0280]); growth factors encompassed by the composition include, but are not limited to, transforming growth factor beta (see [0241]); an alginate that control the rate of degradation of the scaffold (see [0249]); immunostimulatory compounds comprising a TLR agonist wherein said agonist further comprises heparin sulfate or a fragment thereof (see [0047] and [0051]); and, PLG (poly-lactide-co-glycolide) scaffolds were modified to present nanoparticles containing TLR-activating (see [0322]). Lastly, Applicant’s arguments regarding the function of Ali’s invention are not relevant with respect to the 102 rejection because it is noted that the features upon which applicant relies (i.e., Applicant discovered that a scaffold comprising an immunostimulatory component and an inhibitor of induction of Tregs could recruit immune cells from a tumor and enhance their tumor killing activity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). MPEP 2145 states that a statement of intended use may not render a known composition patentable (see In re Sullivan, 498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007)). As disclosed above, the claimed composition is disclosed by Ali. While Ali may include an additional element, the present claims do not exclude any elements not specified in the claims; therefore, the claims are anticipated.
Applicant is reminded that the instant claims recite the transitional phrase “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). In the instant case, the composition requires specific components which are all described within the Mooney reference. MPEP 2131.02 states that when the species is clearly named in a reference, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). As stated above, Mooney disclose of a composition comprising a scaffold which comprises the elements recited in the instant claims such as at least one immunostimulatory compound, at least one compound that inhibits T-cell or dendritic cell suppression, and/or at least one compound that inhibits an immune-inhibitory protein (see [0006]); a cytokine (e.g., a chemoattractant of immune cells, such as dendritic cells) (see [0060]); the compound that inhibits T cell or dendritic cell suppression is a TGF-beta inhibitor (see [0061]); immunostimulatory compounds comprising a TLR agonist wherein said agonist further comprises heparin sulfate or a fragment thereof (see [0043]); and the scaffolds comprise nanoparticles comprising PLGA (see [0036], [0054], and [0069]). As such, Mooney teaches the elements of the present invention. Further, Applicant’s arguments regarding the function of Mooney’s invention are not relevant with respect to the 102 rejection because it is noted that the features upon which applicant relies (i.e., Applicant’s scaffolds recruit and activate immune cells) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). MPEP 2145 states that a statement of intended use may not render a known composition patentable (see In re Sullivan, 498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007)). As disclosed above, the claimed composition is disclosed by Mooney. While Mooney may include an additional element, the present claims do not exclude any elements not specified in the claims; therefore, the claims are anticipated.
Applicant is reminded that the instant claims recite the transitional phrase “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). In the instant case, the composition requires specific components which are all described within the Stephan reference. MPEP 2131.02 states that when the species is clearly named in a reference, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). As stated above, Stephan discloses that the lymphocyte-activating moieties are bound to or incorporated in one or more particles, wherein the particles are microparticles or nanoparticles (see [0009], [0087], and [0171]). Stephan discloses that the particles can be included within injectable structures and/or within scaffolds, and can be formed from any biocompatible polymer including PLGA (see [0048] and [0086]). Stephan discloses that the immune stimulant can be a cytokine, an antibody, a small molecule, an siRNA, a plasmid DNA , and/or a vaccine adjuvant; wherein the cytokine is IL-2, IL-4, IL-10, IL-11, IL-12, IL-15, IL-18, TNF-alpha, IFN-alpha, IFN-beta, IFN-gamma, or GM-CSF (see [0011], [0079], and [0080]). Stephan discloses that the small molecule drugs include TGF-beta inhibitors (see [0081]). Further, Applicant’s arguments regarding the function of Stephan’s invention are not relevant with respect to the 102 rejection because it is noted that the features upon which applicant relies (i.e., Applicant’s scaffolds recruit immune cells, e.g., from a tumor) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). MPEP 2145 states that a statement of intended use may not render a known composition patentable (see In re Sullivan, 498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007)). As disclosed above, the claimed composition is disclosed by Stephan. Thus, while Stephan adds the element of tumor-reactive T lymphocytes, the art also discloses of the elements recited in the instant claims. The present claims do not exclude any elements not specified in the claims; therefore, the claims are anticipated.
As such, the 102 rejections are maintained.
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.
17/642,515
Claims 1, 4-7, 12, 15-17, 19, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-11, 13-14, 16-17, 19-24, 27-37, 41, 46-47, 65, 70, 72, and 80 of copending Application No. 17/642,515 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1, 4-5, 12, 15, and 28, the ‘515 application is drawn to a microparticle or nanoparticle comprising: (a) an antigen specific to a cell or virus of interest; and (b) a costimulatory component derived from an antigen presenting cell (see claim 1). The microparticle or nanoparticle of claim 1, wherein the antigen comprises a tumor antigen; a cancer-specific antigen; a self-antigen; an IgE receptor-specific antigen; a pathogen-specific antigen; an antigen specific to an organ, tissue, or cell of interest; an antigen specific to a transplanted organ, tissue, or cell of interest; a macrophage-specific antigen; an erythrocyte-specific antigen; a platelet- specific antigen; a platelet factor 5-specific antigen; a fibrinogen-specific antigen; a stem cell- or progenitor cell-specific antigen; a lymphocyte-specific antigen; a monocyte-specific antigen; an immune cell-specific antigen; or a stromal cell-specific antigen or a combination thereof (see claim 2). The ‘515 application is drawn to the microparticle or nanoparticle, wherein the antigen comprises a B cell-specific antigen comprising a membrane isolated from a B cell or wherein the antigen comprises a T cell-specific antigen comprising a membrane isolated from a T cell (see claim 5). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, wherein the costimulatory component from an antigen presenting cell comprises a membrane isolated from an antigen presenting cell (see claim 9). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, wherein the microparticle or nanoparticle comprises a polymer (see claim 11). The ‘515 application is drawn to the microparticle or nanoparticle, wherein the polymer is alginate, hyaluronic acid, or chitosan (see claim 13). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, further comprising at least one immunoregulatory compound (see claim 19) wherein the immunoregulatory compound comprises an immunostimulatory compound (see claim 20) or an immunosuppression compound (see claim 21). The ‘515 application is drawn to the microparticle or nanoparticle, wherein the cytokine comprises an interleukin (IL) or stromal cell-derived factor 1a (SDF-1a) (see claim 23). The ‘515 application is drawn to the microparticle or nanoparticle of claim 22, wherein the growth factor comprises transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), or bone morphogenetic protein-2 (BMP-2) (see claims 27 and 28). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, further comprising at least one compound that regulates induction of Tregs (see claims 29-31).
With respect to instant claims 6 and 7, the ‘515 application is drawn to the microparticle or nanoparticle of claim 23, wherein the interleukin comprises interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-10 (IL-10), interleukin-12 (IL-12), or interleukin-15(IL-15) or an IL-2 superkine (see claim 24).
With respect to instant claims 16 and 17, the ‘515 application is drawn to the microparticle or nanoparticle of claim 31, wherein the TGF-β inhibitor is a TGF-β receptor inhibitor (see claim 32). The ‘515 application is drawn to the microparticle or nanoparticle of claim 31, wherein the TGF-β inhibitor is galunisertib (LY2157299) or SB505124 (see claim 33).
With respect to instant claim 19, the ‘515 application is drawn to the microparticle or nanoparticle of claim 1, wherein the microparticle or nanoparticle further comprises heparin (see claim 14).
The difference between the instant claims and the ‘515 application is that the ‘515 application is drawn to methods of using the claimed product. However, with respect to the method of using, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
As such, the ‘515 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-7, 12-13, 15-17, 19, 28, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-11, 13-14, 16-17, 19-24, 27-37, 41, 46-47, 65, 70, 72, and 80 of copending Application No. 17/642,515 (reference application) in view of Stephan (US 2016/0008399 A1, publication date: 01/14/2016). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1, 4, 5, 12, and 15, the ‘515 application is drawn to a microparticle or nanoparticle comprising: (a) an antigen specific to a cell or virus of interest; and (b) a costimulatory component derived from an antigen presenting cell (see claim 1). The microparticle or nanoparticle of claim 1, wherein the antigen comprises a tumor antigen; a cancer-specific antigen; a self-antigen; an IgE receptor-specific antigen; a pathogen-specific antigen; an antigen specific to an organ, tissue, or cell of interest; an antigen specific to a transplanted organ, tissue, or cell of interest; a macrophage-specific antigen; an erythrocyte-specific antigen; a platelet- specific antigen; a platelet factor 5-specific antigen; a fibrinogen-specific antigen; a stem cell- or progenitor cell-specific antigen; a lymphocyte-specific antigen; a monocyte-specific antigen; an immune cell-specific antigen; or a stromal cell-specific antigen or a combination thereof (see claim 2). The ‘515 application is drawn to the microparticle or nanoparticle, wherein the antigen comprises a B cell-specific antigen comprising a membrane isolated from a B cell or wherein the antigen comprises a T cell-specific antigen comprising a membrane isolated from a T cell (see claim 5). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, wherein the costimulatory component from an antigen presenting cell comprises a membrane isolated from an antigen presenting cell (see claim 9). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, wherein the microparticle or nanoparticle comprises a polymer (see claim 11). The ‘515 application is drawn to the microparticle or nanoparticle, wherein the polymer is alginate, hyaluronic acid, or chitosan (see claim 13). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, further comprising at least one immunoregulatory compound (see claim 19) wherein the immunoregulatory compound comprises an immunostimulatory compound (see claim 20) or an immunosuppression compound (see claim 21). The ‘515 application is drawn to the microparticle or nanoparticle, wherein the cytokine comprises an interleukin (IL) or stromal cell-derived factor 1a (SDF-1a) (see claim 23). The ‘515 application is drawn to the microparticle or nanoparticle of claim 22, wherein the growth factor comprises transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), or bone morphogenetic protein-2 (BMP-2) (see claims 27 and 28). The ‘515 application is drawn to the microparticle or nanoparticle of claim 1, further comprising at least one compound that regulates induction of Tregs (see claims 29-31).
With respect to instant claims 6 and 7, the ‘515 application is drawn to the microparticle or nanoparticle of claim 23, wherein the interleukin comprises interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-10 (IL-10), interleukin-12 (IL-12), or interleukin-15(IL-15) or an IL-2 superkine (see claim 24).
With respect to instant claims 16 and 17, the ‘515 application is drawn to the microparticle or nanoparticle of claim 31, wherein the TGF-β inhibitor is a TGF-β receptor inhibitor (see claim 32). The ‘515 application is drawn to the microparticle or nanoparticle of claim 31, wherein the TGF-β inhibitor is galunisertib (LY2157299) or SB505124 (see claim 33).
With respect to instant claim 19, the ‘515 application is drawn to the microparticle or nanoparticle of claim 1, wherein the microparticle or nanoparticle further comprises heparin (see claim 14).
The difference between the instant claims and the ‘515 application is that the instant claims are drawn to nanoparticles comprising PLGA, at least one compound that regulates induction of regulatory T cells is released slowly from the scaffold, and scaffolds comprising one or more immune cells. Additionally, the ‘515 application is drawn to methods of using the claimed product. However, with respect to the method of using, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
Further, Stephan discloses of compositions and methods for the delivery of immune cells to treat un-resectable or non-resected tumor cells and tumor relapse; the compositions comprise (i) a structure comprising an injectable polymer or scaffold comprising pores; (ii) lymphocytes disposed within the structure, (iii) at least one lymphocyte-adhesion moiety associated with the structure; and (iv) at least one lymphocyte-activating moiety associated with the structure, and optionally an immune stimulant (see Abstract). Particularly, Stephan discloses that the lymphocytes are T-cells, specifically CD8+ T cells (see [0007]). Stephan discloses that the lymphocyte-activating moieties are bound to or incorporated in one or more particles, wherein the particles are microparticles or nanoparticles (see [0009], [0087], and [0171]). Stephan discloses that the particles can be included within injectable structures and/or within scaffolds, and can be formed from any biocompatible polymer including PLGA (see [0048] and [0086]). Stephan discloses that the immune stimulant can be a cytokine, an antibody, a small molecule, an siRNA, a plasmid DNA , and/or a vaccine adjuvant; wherein the cytokine is IL-2, IL-4, IL-10, IL-11, IL-12, IL-15, IL-18, TNF-alpha, IFN-alpha, IFN-beta, IFN-gamma, or GM-CSF (see [0011], [0079], and [0080]). Stephan discloses that the small molecule drugs include TGF-beta inhibitors (see [0081]).
With respect to instant claim 13, Stephan discloses that the composition control releases tumor fighting lymphocytes (see [0021]).
As such, it would have been obvious to one of ordinary skill in the art to combine the teachings of the ‘515 application and Stephan to develop the claimed invention. One would be motivated to do so because both Ali et al and Stephan disclose of a composition for elicit immune response in cancer cells which comprise of immunostimulatory scaffolds. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by modifying the invention of the ‘515 application with a scaffold comprising an immune cell (i.e., CD8+ T cell), as described by Stephan, would induce a robust proliferative T-cell response.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17/933,817
Claims 1, 4-7, 12, 15-17, 28, 29, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-35 of copending Application No. 17/933,817 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1, 4, 5, 12, 15, 28, 29, and 42, the ‘817 application is drawn to a porous biocompatible or biodegradable scaffold for regulating an immune response in a subject in need thereof, the scaffold comprising (i) one or more microparticles, (ii) one or more nanoparticles, and (iii) a polymer comprising one or more of alginate, hyaluronic acid, chitosan, and poly(lactic-co-glycolic acid), wherein said one or more microparticles comprise heparin, and the heparin is bound to at least one compound that regulates T cell immune response, wherein said one or more nanoparticles or microparticles comprise at least one compound that regulates induction of regulatory T cells (Tregs) (see claim 1). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the alginate comprises one or more arginine-glycine-aspartate (RGD) peptides (see claim 2). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the one or more nanoparticles or microparticles comprise poly(lactic-co-glycolic acid) (PLGA) (see claim 4). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the at least one compound that regulates T cell immune response comprises a cytokine, a growth factor, an immunostimulatory compound, a chemokine, or an antibody or fragment thereof (see claim 5). The ‘817 application is drawn to the porous scaffold of claim 5, wherein the antibody is covalently bound to the polymer (see claim 7). The ‘817 application is drawn to the porous scaffold of claim 1, comprising one or more silica-heparin microparticles bound to IL-2; one or more PLGA nanoparticles or microparticles comprising a TGF-β inhibitor; and anti-CD3 and anti-CD28 antibodies covalently bound to an alginate-RGD polymer (see claim 10). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the scaffold further comprising one or more immune cells (see claim 11). The ‘817 application is drawn to the porous scaffold of claim 11, wherein the immune cells comprise wild-type or transgenic T cells, murine or human T cells, CD4+ or CD8+ T cells, or chimeric antigen receptor T cells (CAR-T cells) (see claim 12).
With respect to instant claims 6 and 7, the ‘817 application is drawn to the porous scaffold of claim 5, wherein the compound that regulates T cell immune response comprises one or more of interleukin-2 (IL-2), interleukin-4 (IL- 4), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-10 (IL-10), interleukin-12 (IL-12), interleukin-15 (IL-15), TL-2 superkine, chemokine (C-C motif) ligand 21 (CCL21), anti-CD3 antibodies, and anti-CD28 antibodies (see claim 6).
With respect to instant claims 16 and 17, the ‘817 application is drawn to the porous scaffold of claim 1, wherein the at least one compound that regulates induction of regulatory T cells is an inhibitor of transforming growth factor- beta (TGF-β) (see claim 8). The ‘817 application is drawn to the porous scaffold of claim 8, wherein the inhibitor of TGF-β is galunisertib (LY2157299) or SB505124 (see claim 9).
The difference between the instant claims and the ‘817 application is that the ‘817 application is also drawn to a method of using the product. However, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
As such, the ‘817 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-7, 12, 13, 15-17, 19, 28, 29, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-35 of copending Application No. 17/933,817 (reference application) in view of Ali et al (US 2017/0042995 A1, publication date: 02/16/2017) as evidenced by Shriver et al (Handb Exp Pharmacol. 2012 ; (207): 159–176). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1, 4, 5, 12, 15, 28, 29, and 42, the ‘817 application is drawn to a porous biocompatible or biodegradable scaffold for regulating an immune response in a subject in need thereof, the scaffold comprising (i) one or more microparticles, (ii) one or more nanoparticles, and (iii) a polymer comprising one or more of alginate, hyaluronic acid, chitosan, and poly(lactic-co-glycolic acid), wherein said one or more microparticles comprise heparin, and the heparin is bound to at least one compound that regulates T cell immune response, wherein said one or more nanoparticles or microparticles comprise at least one compound that regulates induction of regulatory T cells (Tregs) (see claim 1). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the alginate comprises one or more arginine-glycine-aspartate (RGD) peptides (see claim 2). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the one or more nanoparticles or microparticles comprise poly(lactic-co-glycolic acid) (PLGA) (see claim 4). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the at least one compound that regulates T cell immune response comprises a cytokine, a growth factor, an immunostimulatory compound, a chemokine, or an antibody or fragment thereof (see claim 5). The ‘817 application is drawn to the porous scaffold of claim 5, wherein the antibody is covalently bound to the polymer (see claim 7). The ‘817 application is drawn to the porous scaffold of claim 1, comprising one or more silica-heparin microparticles bound to IL-2; one or more PLGA nanoparticles or microparticles comprising a TGF-β inhibitor; and anti-CD3 and anti-CD28 antibodies covalently bound to an alginate-RGD polymer (see claim 10). The ‘817 application is drawn to the porous scaffold of claim 1, wherein the scaffold further comprising one or more immune cells (see claim 11). The ‘817 application is drawn to the porous scaffold of claim 11, wherein the immune cells comprise wild-type or transgenic T cells, murine or human T cells, CD4+ or CD8+ T cells, or chimeric antigen receptor T cells (CAR-T cells) (see claim 12).
With respect to instant claims 6 and 7, the ‘817 application is drawn to the porous scaffold of claim 5, wherein the compound that regulates T cell immune response comprises one or more of interleukin-2 (IL-2), interleukin-4 (IL- 4), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-10 (IL-10), interleukin-12 (IL-12), interleukin-15 (IL-15), TL-2 superkine, chemokine (C-C motif) ligand 21 (CCL21), anti-CD3 antibodies, and anti-CD28 antibodies (see claim 6).
With respect to instant claims 16 and 17, the ‘817 application is drawn to the porous scaffold of claim 1, wherein the at least one compound that regulates induction of regulatory T cells is an inhibitor of transforming growth factor- beta (TGF-β) (see claim 8). The ‘817 application is drawn to the porous scaffold of claim 8, wherein the inhibitor of TGF-β is galunisertib (LY2157299) or SB505124 (see claim 9).
The difference between the instant claims and the ‘817 application is that the ‘817 application is also drawn to a method of using the product. Additionally, the instant claims are drawn to at least one compound that regulates induction of regulatory T cells is released slowly from the scaffold, and wherein one compound that regulates T cell immune response is bound to heparin.
However, with respect to a method of using the product, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
Further, Ali et al disclose of compositions, methods, and devices for enhancing an endogenous immune response against cancer (see Abstract). Particularly, Ali et al disclose of a device comprising an inhibitor of an immune-inhibitory protein; a scaffold composition; a cell recruitment composition; and a bioactive composition wherein the bioactive composition is incorporated into or coated onto the scaffold composition, and wherein the bioactive composition causes modification of cells in or recruited to the device (see [0005]). Ali et al disclose that the immune-inhibitory protein (e.g., CTLA4 or PD1) enhances the immunosuppressive function of a Treg cell (see [0006]). The device contains a scaffold that comprises open, interconnected macropores comprising a deployment signal capable of inducing or promoting migration of cells wherein the deployment signal comprises a protein, peptide, or nucleic acid that depletes or diffuses of the cell recruitment composition comprising a cytokine, chemokine, or growth factor (see [0012]-[0013]). Examples of cytokines include IL-2 and IL-4 (see [0241] and [0280]).
With respect to claims 12 and 15, Ali et al disclose that growth factors encompassed by the composition include, but are not limited to, transforming growth factor beta (see [0241]).
With respect to claim 13, Ali et al disclose that the claimed scaffold comprises an alginate that control the rate of degradation of the scaffold (see [0249]).
With respect to instant claim 19, Ali et al disclose of immunostimulatory compounds comprising a TLR agonist wherein said agonist further comprises heparin sulfate or a fragment thereof (see [0047] and [0051]). While Ali et al does not explicitly recite heparin, it is known in the art that heparin sulfate contains all of the structural variations found in heparin as evidenced by Shriver et al (see pg. 3).
With respect to claims 28 and 29, Ali et al disclose that PLG (poly-lactide-co-glycolide) scaffolds were modified to present nanoparticles containing TLR-activating (see [0322]).
As such, it would have been obvious to one of ordinary skill in the art to combine the teachings of ‘817 application and Ali et al to develop the claimed invention. One would be motivated to do so because both the ‘817 application and Ali et al disclose of an immunostimulatory, porous scaffold comprising nanoparticles. Additionally, Ali et al teach of developing biodegradable scaffolds comprising heparin bound biomolecules.
Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation that modifying a compound that regulates T cell immune response by linking said compound with heparin will bind to TGF-beta, therefore enhance an immune response (i.e., reduce inflammation).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/719,643
Claims 1, 4-7, 15-17, 19, 28, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-14, and 16-34 of copending Application No. 18/719,643 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1, 4-7, 15-17, 19, 28, and 29, the ‘643 application is drawn to a microparticle comprising: (a) at least one immunogen; and (b) at least one T memory stem cell (TMSC) inducer (see claim 1). The ’643 application is drawn to the microparticle of claim 1, wherein the immunogen is a viral, bacterial, protozoan, helminthic, or cancer antigen (see claim 2). The ‘643 application is drawn to the microparticle of claim 1, further comprising at least one immunostimulatory cytokine (see claim 5). The ‘643 application is drawn to the microparticle of claim 5, wherein the at least one immunostimulatory cytokine is IL-2, IL-7 or IL-15, or any combination thereof (see claim 6). The ‘643 application is drawn to the microparticle of claim 1, further comprising a T cell activator (see claim 7). The ’643 application is drawn to the microparticle of claim 7, wherein the T cell activator is anti-CD3 antibodies and/or anti-CD28 antibodies, or the combination thereof (see claim 8). The ‘643 application is drawn to the microparticle of claim 1, further comprising an RGD peptide (see claim 10). The ‘643 application is drawn to the microparticle of claim 1, further comprising a chemokine (see claim 11). The ‘643 application is drawn to the microparticle of claim 11, wherein the chemokine is CCL21, CCL19, CCL17, CCL22 or any combination thereof (see claim 12). The ‘643 application is drawn to the microparticle of claim 1, further comprising heparin (see claim 13). The ‘643 application is drawn to the microparticle of claim 1, comprising a polymer scaffold (see claim 14). The ‘643 application is drawn to the microparticle of claim 1, wherein the TMSC inducer is provided in a nanoparticle within the microparticle (see claim 16). The ‘643 application is drawn to the microparticle of claim 16, wherein the nanoparticle comprises PLGA (see claim 17). The ‘643 application is drawn to the microparticle of claim 1, wherein the microparticle comprises a porous scaffold (see claim 18). The ‘643 application is drawn to the microparticle of claim 1, wherein the porous scaffold comprises anti-CD3 or anti-CD28 antibodies bound to or cross-linked to heparin (see claim 19). The ‘643 application is drawn to the microparticle of claim 14, wherein the polymer comprises alginate, hyaluronic acid, polycaprolactone, poly(lactic acid), or PLGA (see claim 34).
The difference between the instant claims and the ‘643 application is that the ‘643 application is also drawn to a method of using the product. However, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
As such, the ‘643 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-7, 13, 15-17, 19, 28, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-14, and 16-34 of copending Application No. 18/719,643 (reference application) ) in view of Stephan (US 2016/0008399 A1, publication date: 01/14/2016). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With respect to instant claims 1, 4-7, 13, 15-1, 19, 28, and 29, the ‘643 application is drawn to a microparticle comprising: (a) at least one immunogen; and (b) at least one T memory stem cell (TMSC) inducer (see claim 1). The ’643 application is drawn to the microparticle of claim 1, wherein the immunogen is a viral, bacterial, protozoan, helminthic, or cancer antigen (see claim 2). The ‘643 application is drawn to the microparticle of claim 1, further comprising at least one immunostimulatory cytokine (see claim 5). The ‘643 application is drawn to the microparticle of claim 5, wherein the at least one immunostimulatory cytokine is IL-2, IL-7 or IL-15, or any combination thereof (see claim 6). The ‘643 application is drawn to the microparticle of claim 1, further comprising a T cell activator (see claim 7). The ’643 application is drawn to the microparticle of claim 7, wherein the T cell activator is anti-CD3 antibodies and/or anti-CD28 antibodies, or the combination thereof (see claim 8). The ‘643 application is drawn to the microparticle of claim 1, further comprising an RGD peptide (see claim 10). The ‘643 application is drawn to the microparticle of claim 1, further comprising a chemokine (see claim 11). The ‘643 application is drawn to the microparticle of claim 11, wherein the chemokine is CCL21, CCL19, CCL17, CCL22 or any combination thereof (see claim 12). The ‘643 application is drawn to the microparticle of claim 1, further comprising heparin (see claim 13). The ‘643 application is drawn to the microparticle of claim 1, comprising a polymer scaffold (see claim 14). The ‘643 application is drawn to the microparticle of claim 1, wherein the TMSC inducer is provided in a nanoparticle within the microparticle (see claim 16). The ‘643 application is drawn to the microparticle of claim 16, wherein the nanoparticle comprises PLGA (see claim 17). The ‘643 application is drawn to the microparticle of claim 1, wherein the microparticle comprises a porous scaffold (see claim 18). The ‘643 application is drawn to the microparticle of claim 1, wherein the porous scaffold comprises anti-CD3 or anti-CD28 antibodies bound to or cross-linked to heparin (see claim 19). The ‘643 application is drawn to the microparticle of claim 14, wherein the polymer comprises alginate, hyaluronic acid, polycaprolactone, poly(lactic acid), or PLGA (see claim 34).
The difference between the instant claims and the ‘643 application is that the ‘643 application is also drawn to a method of using the product. Additionally, the instant claims are drawn to at least one compound that regulates induction of regulatory T cells is released slowly from the scaffold, and wherein one compound that regulates T cell immune response is bound to heparin.
However, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
Further, Stephan discloses of compositions and methods for the delivery of immune cells to treat un-resectable or non-resected tumor cells and tumor relapse; the compositions comprise (i) a structure comprising an injectable polymer or scaffold comprising pores; (ii) lymphocytes disposed within the structure, (iii) at least one lymphocyte-adhesion moiety associated with the structure; and (iv) at least one lymphocyte-activating moiety associated with the structure, and optionally an immune stimulant (see Abstract). Particularly, Stephan discloses that the lymphocytes are T-cells, specifically CD8+ T cells (see [0007]). Stephan discloses that the lymphocyte-activating moieties are bound to or incorporated in one or more particles, wherein the particles are microparticles or nanoparticles (see [0009], [0087], and [0171]). Stephan discloses that the particles can be included within injectable structures and/or within scaffolds, and can be formed from any biocompatible polymer including PLGA (see [0048] and [0086]). Stephan discloses that the immune stimulant can be a cytokine, an antibody, a small molecule, an siRNA, a plasmid DNA , and/or a vaccine adjuvant; wherein the cytokine is IL-2, IL-4, IL-10, IL-11, IL-12, IL-15, IL-18, TNF-alpha, IFN-alpha, IFN-beta, IFN-gamma, or GM-CSF (see [0011], [0079], and [0080]). Stephan discloses that the small molecule drugs include TGF-beta inhibitors (see [0081]).
With respect to instant claim 13, Stephan discloses that the composition control releases tumor fighting lymphocytes (see [0021]).
As such, it would have been obvious to one of ordinary skill in the art to combine the teachings of ‘643 application and Stephan to develop the claimed invention. One would be motivated to do so because both the ‘643 application and Stephan disclose of an immunoregulatory compounds comprising nanoparticles. Additionally, Stephan teaches of developing biodegradable scaffolds comprising heparin bound biomolecules.
Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by modifying the invention of the ‘643 application with a scaffold comprising immune cells, as described by Stephan, would induce a robust proliferative T-cell response. Furthermore, one of skill in the art would have a reasonable expectation that modifying a compound that regulates T cell immune response by linking said compound with heparin will bind to TGF-beta, therefore enhance an immune response (i.e., reduce inflammation).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments
Applicant traverses the double patenting rejections (see pages 19 and 20 of the Remarks filed on 02/06/2026).
Applicant points out that the claims in the ‘515 application include the presence of an antigen in the microparticles or nanoparticles; the instant claims’ porous scaffolds do not comprise an antigen. Additionally, Applicant points out that the claims in the ‘643 application include the presence of an immunogen in the microparticles; the instant claims’ porous scaffolds do not comprise an immunogen (antigen).
With respect to the ‘817 application, Applicant respectfully requests that the rejection be reassessed once claims herein are allowable.
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive.
Applicant is reminded that the instant claims recite the transitional phrase “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). Thus, while the ‘515 and ‘643 applications recite additional elements, the reference applications also recite elements claimed in the present application.
Applicant is reminded that a request for a rejection to be held in abeyance does not “distinctly and specifically points out the supposed errors in the examiner’s action” as required under 37 CFR 1.111. See MPEP 714.02.
Further, Applicant is advised that a rejection under double patenting precludes the identification of allowable subject matter. Applicant has not filed a terminal disclaimer, and the claims remain rejected for reasons set forth above.
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As such, the double patenting rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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