DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, 10, 14-21, and 37-43 are pending. Claims 3-4, 6-7, and 9-13 were canceled; claims 37-43 were added; and claims 1, 10, 14-15, and 20-21 were amended in the Response filed 11/18/2025. Claims 10, 14-21, 37, and 43 are withdrawn. Claims 1 and 38-42 are presently considered.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-9, directed to a product referred to as a “Drug delivery circuit” comprising “a plurality of biocomparators” and “a plurality of activatable drug delivery agents” as filed in the 3-page amended claim set of 3/16/2021) and a species of Example 1 in the reply filed on 3/12/2024 was previously acknowledged, and the traversal was found non-persuasive for reasons of record (see, e.g., Action mailed 4/01/2024 at pages 2-3), and the requirement was made final (see id.).
The originally elected species was previously deemed allowable in the Action mailed 4/01/2024 (see, e.g., Action mailed 4/01/2024 at pages 2-7). However, as explained in the Action mailed 10/09/2024, the amended claim scope as filed 8/01/2024 was understood to exclude the originally elected species (see, e.g., Action mailed 10/09/2024 at pages 2-3). Newly amended claim 1 is understood to read upon the originally elected species as shown in the Reply (see, e.g., Reply filed 11/18/2025 at 9 showing an “example claim” that is not actually recited in the pending claim scope, and lacks the detectable signal molecules). Accordingly, the originally elected species is understood to read upon the genus of pending claims 1, but no claim directed to the originally elected species is presently claimed.
Regarding newly added claim 37, the originally elected species comprised bacterial and viral proteases (e.g., OmpT, WNVp, TEVp), but did not comprise a “cancer-associated proteins” within the group disclosed in the Specification (see, e.g., Spec. filed 3/17/2021 at 4 at lines 7-11, p. 14 at lines 10-30). Accordingly, claim 37 is directed to a non-elected species. Regarding newly added claim 43, the originally elected species was a product as it existed prior to addition of a lipase, and therefore claim 43 is directed to a non-elected species.
The originally elected species was previously deemed allowable in the Action mailed 4/01/2024 (see, e.g., Action mailed 4/01/2024 at pages 2-7). Examination has proceeded to a non-elected species within the genus of amended claim 1, which has been rejected under 35 USC 112(a), as explained below.
Claims 10 and 14-21 remain 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/12/2024.
Claims 37 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/12/2024.
Claims 1 and 38-42 are presently considered.
Information Disclosure Statement
The IDS filed 1/08/2026 is acknowledged and presently considered.
Examiner notes that all poster sessions, poster abstracts, publications, talks, presentation, etc. in 2019 or earlier, made by either or both inventors, are germane to prosecution and should be placed on record in an IDS.
Denial of Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional 62/733,287 (filed 9/19/2018) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Claim 1 is representative of the pending claim scope. Claim 1 does not literally appear in the Pro’287, therefore the claims lack literal support in the Pro’287.
Accordingly, Pro’287 fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’287 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in Pro’287, at least because instant claim 1 and its dependents attempt to retroactively create a broad and highly variable genus, that was not literally disclosed on record, wherein the closest supporting disclosure in Pro’287 is Fig. S3 and the Table at pages 22-23. However, this closest supporting disclosure, at best, corresponds to a a single, disclosed example, which is static and non-variable with respect to the specific polymers, crosslinks, proteases, cleavable peptide sequences, quenchers, and fluorophores. Therefore, such disclosure is not commensurate in scope either implicitly or inherently with the instantly pending claims. In addition, the phrase “cleavable peptide comprising a C-terminal lysine” does not appear in the provisional document. Accordingly, the disclosure of Pro’287 does not provide written description support commensurate in scope with a subgenus synonymous and equivalent in scope with instant claim 1.
Accordingly, Pro’287 fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to , US Provisional 62/733,287 (filed 9/19/2018) is denied for claim 1 and all of the dependents of those claims; these claims have been accorded a priority date of 9/19/2019, which corresponds to the filing date of PCT/US19/51833 (filed 9/19/2019).
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111 If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action1.
Applicable claim interpretations have been previously discussed and set forth on record, and those are incorporated herein.
Withdrawn Claim Rejections
All prior rejections are withdrawn in view of the extensive amendments filed 11/18/2025. However, the amendments have necessitated new and revised rejections.
New or Revised Claim Rejections as Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and 38-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein each liposome”, and “liposome” lacks antecedent basis because “liposome” is not equivalent to “caged liposome” (see, e.g., Nystrom v. TREX Co., Inc., 424 F. 3d 1136, 1143 (Fed. Cir. 2005), noting that different words or phrases give rise to an presumption that a difference in meaning is intended). For purposes of applying prior art, the reference to “liposome” is understood to mean “caged liposome”. Clarification is required.
Claim 38 attempts to functionally limit the “protease-cleavable peptide” by specifically limiting it to structures that are “cleavable by a bacterial protease” (see, e.g., instant claim 38). Accordingly, the scope of claim 38 differs from claim 1 only by the recitation of a functional limitation. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008)
Here, the functionally defined subgenus of “protease-cleavable peptides” does not correspond to a structure/function relationship of record, and no consensus structure for peptide sequences included or excluded from the scope of claim 38 by this functional limitation is known or discussed on record in the context of instant claim 1. Accordingly, it is unclear what structures of “protease-cleavable peptides” within the scope of amended claim 1 are excluded from the scope of claim 38 by the functional limitation requiring that the “protease-cleavable peptide” is specifically “cleavable by a bacterial protease”. Accordingly, the Specification does not reasonably inform an artisan how to distinguish between infringing and non-infringing compounds, because an artisan would not be aware of what structures did or did not possess the requisite functionally defined structures as presently claimed. The Courts have stated that
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 the 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.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, claim 38 is rejected as indefinite in view of the recitation of a functional limitation that does not correspond to a structure/function relationship of record because an artisan would be unaware of the metes and bounds sufficient to apprise an artisan of infringing and non-infringing compounds.
Claims 38-42 depend directly or indirectly from an indefinite base claim, and fail to reconcile the indefiniteness of the base claim. Accordingly, claims 38-42 are rejected for the reasons applied to claim 1.
Claims 1 and 38-42 are rejected.
Claim Rejections - 35 USC § 112(a), New Matter
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 and 38-42 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.
Applicable Case Law
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Lack of literal Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Amended claim 1 is representative of the pending claims scope and does not literally appear anywhere in the originally filed disclosure “as an integrated whole”2 as instantly claimed.
Upon review of the Reply filed 11/18/2025, it is noted that Applicant failed to identify any disclosure in the originally filed application that literally disclosed amended claim 1 using either synonymous or equivalent terminology.
Accordingly, the pending claims, having the equivalent or synonymous scope instantly claimed, do not literally or inherently appear in the originally filed disclosure.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163. As noted above, the claims are not literally or inherently supported by the originally filed disclosure. Accordingly, the relevant issue is whether or not the new amendments and resulting claim scope is implicitly or inherently supported by the originally filed disclosure.
Amendments do not correct an obvious error: Per MPEP § 2163(I)(B), “[a]n amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971)”. Here, no allegation that the amendments correct an obvious error has been made. Furthermore, upon inspection, Examiner is unable to identify any single “obvious error” that would lead to instantly amended claim 1 and the scope thereof. Accordingly, the amendments cannot be said to correct an “obvious error”.
No implicit or inherent support exists commensurate in scope with the instant claims: the closest supporting disclosure appears at Example 1 (see, e.g., Reply filed 11/18/2025 at 9 showing an “example claim” that is not actually recited in the pending claim scope, and lacks the detectable signal molecules; see, e.g., Spec. filed 3/17/2021 at 34 at line 24 to page 39 at line 10). However, Example 1 is a highly specialized and complex system having defined concentrations of components, specific sequences, specific crosslinkers, specific proteases, specific liposome formulations, substrates, etc., which are disclosed as an integrated whole defining one species of the claimed genus of systems3, and the specifics of Example 1 are neither claimed nor required at the amended claims (see, e.g., Spec. filed 3/17/2021 at 34 at line 24 to page 39 at line 10). Therefore, Example 1 does not reasonably provide implicit or inherent support for the vast and highly varied subgenus of amended claim 1.
The amended claim scope is vast and highly varied: The pending claim scope pertains to a previously unclaimed, undisclosed genus of “systems”, wherein the amended claim now reads upon >>trillions of species, wherein each species of “system” is defined as unique combinations of different liposomes having different compositions, different cholesterol-anchored polymers, different crosslinks, different protease-cleavable peptides, different first proteases, different second proteases, different inhibitors, different first quenchers, different second quenchers, different first fluorophores, different second fluorophores, different second protease cleavage sites, different first protease cleavage sites, in addition to variable, unclaimed components the invention may “comprise”. Accordingly, the amended claim scope is vast and highly varied, but does not literally, implicitly, or inherently appear in the originally filed disclosure. MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Accordingly, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Here, the claims read upon >>trillions of species of unique systems differing by numerous components. Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, here the disclosure of a single species of “system” within a genus that is literally absent from the originally filed disclosure cannot reasonably be said to provide sufficient disclosure to satisfy the written description requirement.
Accordingly, the originally filed disclosure cannot be said to provide implicit or inherent support commensurate in scope with amended claim 1.
Consideration of Alleged Supporting Disclosures
In the Reply filed 11/18/2025, it is the Examiner’s understanding that the Applicant attempts to recite supporting disclosures by directing the Examiner to numerous disjointed pages, which do not literally disclose the language of instant claims 1 or 38-42 (see, e.g., Reply filed 11/18/2025 at 6 at 1st to 3rd ¶¶). Specifically, Applicant refers to “paragraphs [0016], [0056], and [0057]”, “Fig. 2A and Fig. 4A”, “paragraphs [0129] and [0137]”, and “Table 1 and Table 2” (see id.). As an initial matter, the originally filed specification did not include paragraph numbers, and therefore it is presumed that the citations refer to US20220249369. Second, upon inspection, none of the cited portions literally disclose the pending claim scope. Third, none of the cited portions provide inherent or implicit support commensurate in scope with the amended claim scope and genus of embodiments now claimed. Specifically, Figure 2A requires biocomparators, signal proteases, and peptide caged liposomes, which are not actually recited in the claims, and are not equivalent or synonymous in scope with any terms utilized in the amended claim scope (see, e.g., US’369 at Fig. 2A); furthermore, Figure 2A appears to pertain to a method of exposing four “biocomparators” to a lipase to open a “peptide caged liposome”, in order to quench probes, and instant claim 1 is directed to a “system”, not a method (see, e.g., US’369 at Fig. 2A). Figure 4A and [0016] are related and the disclosures require a specified liposome structure including a peptide comprising “IEFDSGK”, which is not recited or required by instant claim 1 (see, e.g., US’369 at Fig. 4A, ¶[0016]); furthermore, figure 4A displays a single “liposome (Biocomparator)” rather than three liposomes as instantly claimed; furthermore, [0016] pertains to embodiments requiring an N- and C-terminal amines reacted with a carboxylic acid side group of poly(acrylic acid) (see, e.g., US’369 at Fig. 4A, ¶[0016]). Accordingly, Figure 4A and [0016] do not literally, inherently, or implicitly disclose the vast and highly varied genus of systems disclosed at amended claim 1. Paragraphs [0056]-[0057] pertain to signal proteases released from peptide caged biocomparators, quencher molecules, and usage of probes to generate digital outputs (see, e.g., US’369 at ¶¶[0056]-[0057]); therefore these paragraphs do not literally, inherently, or implicitly disclose the vast and highly varied genus of systems disclosed at amended claim 1. Paragraph [0129] pertains to Example 1, which was considered in more detail above; paragraph [0129] pertains to a flash analog-to-digital converter, reference voltages, “activated comparators”, “biological analogs of comparators”, “liposomes locked by an outer peptide cage”, buffer gates, degraded cages, a “unique combination of inhibitors and signal proteases . . . that collectively act to assign priority to the highest activated biocomparator”, and a system specifically requiring the following: SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 9, WNV protease, TEV protease, WNV inhibitor, and GzmB (see, e.g., US’369 at ¶[00129]). However, the pending claims do not require “activated comparators” or “flash-analog-to-digital converter”, etc.; and furthermore the amended claims are not limited to a system requiring SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 9, WNV protease, TEV protease, WNV inhibitor, and GzmB (see, e.g., US’369 at ¶[00129]). Accordingly, this paragraph does not literally, inherently, or implicitly disclose the vast and highly varied genus of systems disclosed at amended claim 1. Paragraph [0137] pertains to Example 2, which is a “biomedical application” wherein “the biological ADC was interfaced with a living system as a plug-and-play therapeutic biocircuit for digital drug delivery” specifically limited to clearing red blood cells of DH5α e. coli cells, which recites and requires “biocomparators”, “liposomes” having SEQ ID NO: 9, protease OmT, “[a] series of 8 biocomparators with increasing peptide densities, “anionic peptide locks”, “drug-lock peptides . . . linked in tandem by OR gate peptides”, as well as SEQ ID NOs: 20 and 21 (see, e.g., US’369 at ¶[00137]). Accordingly, this paragraph does not literally, inherently, or implicitly disclose the vast and highly varied genus of systems disclosed at amended claim 1, which does not require SEQ ID NOs: 9, 20, 21, or multiple other components enumerated at [0137]. Tables 1-2 recite SEQ ID NOs: 6-19 and various proteases and peptides, which are not actually recited or required at amended claim 1 (see, e.g., US’369 at ¶[00126] at Tables 1-2). Tables 1-2 are silent regarding the recited and required liposomes at instant claim 1, and therefore these Tables do not literally, inherently, or implicitly disclose the vast and highly varied genus of systems disclosed at amended claim 1. In sum, all disclosures have been fully considered individually and in combination, but such disclosures do not literally, implicitly, or inherently disclose the genus and subgenera recited at instant claims 1 and 38-42, having the limitations recited at the new and amended claims, because the pending claims do not recite nor require the specific arrangements and combinations of components and limitations discussed at Figures 2A, 4A, ¶¶[0016], [0056], [0057], [0129], [0137] or Tables 1-2 (see, e.g., Reply filed 11/18/2025 at 6 at 1st to 3rd ¶¶).
Additional arguments by Applicant do not identify literal, inherent, or implicit support commensurate in scope with the pending claim scope: It is the Examiner’s understanding that Applicant is attempting to retroactively recreate a novel subgenus, heretofore unseen on record, by utilizing Example 1 as a starting point (see, e.g., Reply filed 11/18/2025 at 6 at § “35 U.S.C. § 112” to p. 9 at 1st full ¶), drafting a novel and hypothetical claim that is not actually pending (see id. at 9), and then alleging that in view of multiple non-patent literature references that the amended claim scope would have been obvious (see, e.g., Reply filed 11/18/2025 at 9 at penultimate ¶ to 16 at final ¶, alleging what “one of skill in the art would be able to” do, rather than discussing what was actually disclosed). This attempt to retroactively create a synthetic subgenus that was not inherently, implicitly, or literally disclosed by the originally filed disclosure is insufficient to satisfy the requirements of 35 USC § 112(a). Although the originally-filed disclosure may render the instant claims obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572). This is consistent with the other court decisions rejecting attempts to retroactively create a genus or subgenus by cobbling together various portions of a disclosure (see, e.g., In re Smith (458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972), noting that “[w]hatever may be the viability of an inductive-deductive approach to arriving at a claimed subgenus, it cannot be said that such a subgenus is necessarily described by a genus encompassing it and a species upon which it reads").
Applicant’s reliance upon non-patent literature is misplaced: It is the Examiner’s understanding that Applicant is attempting to retroactively recreate a novel subgenus at least in part by relying upon multiple non-patent literature references (see, e.g., Reply filed 11/18/2025 at 9 at penultimate ¶ to 16 at final ¶, alleging what “one of skill in the art would be able to” do, rather than discussing what was actually disclosed). First, The courts have addressed such rationales, and noted that they are generally insufficient because "[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement" (see, e.g., Genentech, Inc. v. Novo Nordisk, A/S, 108 F.2d 1361, 1366 (Fed. Cir. 1997); see also Automotive Technologies International v. BMW of North America, 501 F. 3d 1274, 1283, noting that "Although the knowledge of one skilled in the art is indeed relevant, the novel aspect of an invention must be enabled in the patent"). Second, the reliance upon non-patent literature references is understood to be an improper attempt to incorporate such disclosures by reference. Per 37 C.F.R. 1.57(d), “essential material” required to establish written description support may only be incorporated by reference from a US patent or US patent application. Third, Applicant attempts to rely upon post-filed non-patent literature published years after filing (see, e.g., Reply filed 11/18/2025 at 9-10 at bridging ¶, referring to Mac et al. published in 2022), which does not represent the state of the art at the time of filing (see, e.g., MPEP § 2163). Accordingly, such reliance is improper and does not establish nor support possession commensurate in scope with the requirements of 35 USC §112(a) years prior to the publication of such literature. In sum, the novel aspects of the invention must be literally, inherently, or implicitly supported by the as-filed disclosure.
Attempts to retroactively create a novel genus or subgenus by pointing to disjointed portions of a disclosure, without “blaze marks”, are generally insufficient to satisfy the requirements of 35 USC 112(a): Regarding numerous disjointed disclosures that do not literally recite or refer to the invention as claimed, the courts have previously addressed situations wherein an artisan originally provides a “laundry list” disclosure and subsequently attempts to combine various portions of the disclosure to arrive at a novel subgenus (see Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000), stating that "[t]here is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion"). Similarly, the arbitrary combination of limitations from numerous disjointed portions of a broad disclosure, while arbitrarily and selectively ignoring large portions of the original disclosure amounts to an attempt to “carve[] out a patentable portion” of the original disclosure fails to satisfy 35 USC 112(a). Like in Purdue Pharma, disjointed disclosures combined with selectively ignoring vast portions of the disclosure leading artisans away from the desired subgenus now claimed, is not sufficient to satisfy the requirements of 35 USC 112(a). The courts have stated that
“A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention” (see Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323, 1329 (Fed. Cir. 2021).
The courts have also noted
As Ruschig makes clear, one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree [*1327] must be in the originally filed disclosure. . . . It is "not a question of whether one skilled in the art might be able to construct the patentee's device from the teachings of the disclosure.... Rather, it is a question whether the application necessarily discloses that particular device. . .
Purdue Pharma LP v. Faulding Inc., 230 F.3d 1320, 1327, 56 U.S.P.Q.2d 1481, 1486, 2000 BL 26918, at *7 (Fed. Cir. 2000)
Here, no “blaze marks” have been identified in the originally filed disclosure commensurate in scope with the pending claims, because the originally filed disclosure discloses a “forest” (utilizing numerous vague, indefinite terms as evidenced by the instant record), rather than the “tree” presently claimed. Stated alternatively, if the instant disclosure were actually a prior art reference that could be applied against the instantly claimed inventions, the instant disclosure would not be sufficient to establish a 35 USC 102 rejection on anything other than the single, disclosed embodiment at Example 1.
Accordingly, the subgenera recited at new claim 1 does not literally appear in the originally filed disclosure “as an integrated whole”, and is not inherently or implicitly supported commensurate in scope with the instant claim using equivalent or synonymous terminology supported by the original disclosure.
Conclusion
Per MPEP § 2163, new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement (see, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971)). Here, the newly added claim limitations result in a novel claim genus which encompasses trillions of species, and the novel subgenus was not inherently, implicitly, or literally supported by the originally filed disclosure.
As noted above, regarding narrowing amendments attempting to carve a narrower genus from a broad and highly varied genus and laundry list disclosure, the case law and MPEP guidance states, per MPEP § 2163.05(II), that the introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) . . . . ; Rozbicki v. Chiang, 590 Fed.App’x 990, 996 (Fed. Cir. 2014) (non-precedential) (The court found that patentee, "while attempting to obtain the broadest claim language possible during prosecution, cannot now improperly narrow its language by importing limitations not supported by the claim language or written description."). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989).
This courts have clearly stated that the mere disclosure of “each ... individual limitations” separately and distinctly, does not evidence possession of all combinations of all such limitations “as an integrated whole” because written description support requires more than the combination of “an amalgam of disclosures plucked selectively from the ... application” (see, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”). Here, the selective inclusion and selective exclusion of particular combinations of limitations set forth in the laundry list disclosure of possibilities in the originally filed disclosure in order to arrive at a narrower genus of species that was not reasonably or specifically identified or described “as an integrated whole” in the originally filed disclosure is a violation of the written description requirement.
Although the originally-filed disclosure may render the instant claims obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572).
In sum, the pending claims are not literally, inherently, or implicitly supported by the originally filed disclosure.
Accordingly, claims 1 and 38-42 are rejected.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive. The arguments have been fully considered but rendered substantially moot in view of the new or revised rejections set forth above.
It is the Examiner’s understanding that Applicant traverses the traverses the previous rejection under 35 USC § 112(a) at pages 6-16 (see, e.g., Reply filed 11/18/2025 at 6 at § “35 U.S.C. § 112” to p. 16 at final ¶). This argument has been fully considered but not found persuasive for at least the reasons discussed below.
It is the Examiner’s understanding that Applicant is alleging that written description support exists, commensurate in scope with the requirements of 35 USC 112(a), for a heretofore unseen and novel genus encompassing >trillions of different species of “systems” (see, e.g., Reply filed 11/18/2025 at 6 at § “35 U.S.C. § 112” to p. 16 at final ¶). The basis for this support is understood to be premised upon (i) utilizing Example 1 as a starting point (see, e.g., Reply filed 11/18/2025 at 6 at § “35 U.S.C. § 112” to p. 9 at 1st full ¶); (ii) creating a hypothetical claim directed to a narrow subgenus of Example 1, which is not actually claimed (see, e.g., Reply filed 11/18/2025 at 9); then (iii) repeatedly broadening the hypothetical claim with respect to various limitations of Example 1 on the basis of specifically selected disclosures and multiple non-patent literature references (see, e.g., Reply filed 11/18/2025 at 9 at penultimate ¶ to 16 at final ¶), and (iv) arriving at the vast and highly varied genus of instantly amended claim 1 (see, e.g., Reply filed 11/18/2025 at 15-16 at “claim 1”). It is the Examiner’s understanding that that steps (i)-(iv) are “based on the disclosure of the instant application and the general knowledge in the art” and that “one of skill in the art would be able to” arrive from Example 1 to the instant genus of claim 1 (see, e.g., Reply filed 11/18/2025 at 10 at 1st partial ¶, 10 at final ¶, 11 at final ¶, 12 at ¶ in middle of page, 13 at 1st full ¶, 14 at 1st full ¶, 15 at ¶ beginning with “as such”). The argument that an artisan “would be able to” arrive at the invention from the disclosure is understood to be analogous to an argument that the amended claim is “obvious” in view of the non-patent literature and originally filed disclosure. The Applicant’s position does not reflect applicable US patent law and is not persuasive for reasons discussed in more detail below.
Applicant does not dispute that the amended claim scope lacks literal support in the originally filed disclosure: The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163. It is the Examiner’s understanding that it is presently undisputed on record that the claims are not literally disclosed in the originally filed disclosure. Accordingly, all arguments are understood to be premised upon allegations of inherent or implicit support.
Applicant’s reliance upon non-patent literature is misplaced: It is the Examiner’s understanding that Applicant is attempting to retroactively create a novel genus at least in part by relying upon multiple non-patent literature references (see, e.g., Reply filed 11/18/2025 at 9 at penultimate ¶ to 16 at final ¶).
First, the courts have addressed such rationales, and noted that they are generally insufficient because "[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement" (see, e.g., Genentech, Inc. v. Novo Nordisk, A/S, 108 F.2d 1361, 1366 (Fed. Cir. 1997); see also Automotive Technologies International v. BMW of North America, 501 F. 3d 1274, 1283, noting that "Although the knowledge of one skilled in the art is indeed relevant, the novel aspect of an invention must be enabled in the patent").
Second, the reliance upon non-patent literature references is understood to be an improper attempt to incorporate such disclosures by reference. Per 37 C.F.R. 1.57(d), “essential material” required to establish written description support may only be incorporated by reference from a US patent or US patent application.
Third, Applicant attempts to rely upon post-filed non-patent literature published years after filing (see, e.g., Reply filed 11/18/2025 at 9-10 at bridging ¶, referring to Mac et al. published in 2022), which does not represent the state of the art at the time of filing (see, e.g., MPEP § 2163). Accordingly, such reliance is improper and does not establish nor support possession commensurate in scope with the requirements of 35 USC §112(a) years prior to the publication of such literature.
Fourth, the hypothetical knowledge of one of skill in the art is not the test for written description support, but rather “it is the specification itself that must demonstrate possession” (see, e.g., Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F. 3d 1336 (Fed. Cir. 2010)).
In sum, the Applicant’s reliance upon non-patent literature in support is misplaced, because the novel aspects of the invention must be literally, inherently, or implicitly supported by the as-filed disclosure. Furthermore, post-filed references do not represent the state of the art at the relevant time.
Obviousness is not the test for Written Description Support: It is the Examiner’s understanding that that steps (i)-(iv), as discussed above, are “based on the disclosure of the instant application and the general knowledge in the art” and that “one of skill in the art would be able to” arrive from Example 1 to the instant genus of claim 1 (see, e.g., Reply filed 11/18/2025 at 10 at 1st partial ¶, 10 at final ¶, 11 at final ¶, 12 at ¶ in middle of page, 13 at 1st full ¶, 14 at 1st full ¶, 15 at ¶ beginning with “as such”). The argument that an artisan “would be able to” arrive at the invention from the disclosure is understood to be analogous to an argument that the amended claim is “obvious” in view of the non-patent literature and originally filed disclosure. Although the originally-filed disclosure may render the instant claims obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572). Stated alternatively, if the instant disclosure were actually a prior art reference that could be applied against the instantly claimed inventions, the instant disclosure would not be sufficient to establish a 35 USC 102 rejection on anything other than the single, disclosed embodiment at Example 1, which is not actually claimed. Rather, at best, it could be utilized to form an obviousness rejection relative to other species, and “obviousness” is not sufficient to establish written description support (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)).
No evidence of record establishes that an artisan would make the mental leaps required to arrive at the broad genus and subgenera of the pending claims: Applicant sets forth a roadmap leading from a claim representing Example 1 to a broad claim corresponding to instant claim 1, but arrives at the instant claim in incremental steps that an artisan would not reasonably make in view of the originally filed disclosure (see, e.g., Reply filed 11/18/2025 at 10 at 1st partial ¶, 10 at final ¶, 11 at final ¶, 12 at ¶ in middle of page, 13 at 1st full ¶, 14 at 1st full ¶, 15 at ¶ beginning with “as such”). First, the disclosure pertaining to Example 1 identifies that the example is a “unique combination of inhibitors and signal proteases . . . that collectively act to assign priority to the highest activated biocomparator”, and the system specifically requires the following: SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 9, WNV protease, TEV protease, WNV inhibitor, and GzmB (see, e.g., US’369 at ¶[00129]). In view of a disclosure pertaining to a “unique combination”, the Applicant fails to identify why an artisan would reach a genus in a piecemeal fashion requiring the artisan to ignore the “unique combination” disclosed as a whole by the disclosure. Second, Applicant completely ignores and dismisses the actual, non-equivalent language set forth in the originally filed disclosure, which was repeatedly rejected as indefinite (see, e.g., Action mailed 4/01/2024 at 12-18; see also Action mailed 10/09/2024 at 12-14; see also Action mailed 6/18/2025 at 12-16), including language such as “biocomparator”, “peptide lock”, “peptide cage”, “lipid core”, etc., etc. Zero evidence of record establishes that such terms had any unambiguous and art-recognized meaning; therefore assertions that an artisan would or could make the required mental leaps to arrive at the novel genus of claim 1 from the originally filed disclosure is not credible. Such assertions amount to attempts to merely dismiss all inconvenient portions of the disclosure, replete with indefinite and vague terminology, without actually addressing how such language would be meaningfully interpreted by one of skill in the art in the manner required to follow the rationale required to arrive at instant claim 1 (see, e.g., Reply filed 11/18/2025 at 10 at 1st partial ¶, 10 at final ¶, 11 at final ¶, 12 at ¶ in middle of page, 13 at 1st full ¶, 14 at 1st full ¶, 15 at ¶ beginning with “as such”). In sum, assertions of what conclusions an artisan “would have” or “could have” drawn from the instant disclosure, in the absence of clear literal, inherent, or implicit support, are understood to be arguments of counsel, unsupported by objective evidence. This is reasonable, because when an explicit limitation in a claim "is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill would have understood, at the time the patent application was filed, that the description requires that limitation." Hyatt v. Boone, 146 F.3d 1348, 1353, 47 USPQ2d 1128, 1131 (Fed. Cir. 1998). See also In re Wright, 866 F.2d 422, 425, 9 USPQ2d 1649, 1651 (Fed. Cir. 1989). Here, the original claims and supporting disclosures discuss myriad limitations and possibilities, but do not reasonably convey that the described invention required the claimed limitations as set forth in the amended claims, because such limitations are not presented as an integrated whole.
No inherent or implicit disclosures commensurate in scope with the instant claims has been identified on record: All disclosures identified by the Applicant (see, e.g., Reply filed 11/18/2025 at 6 at 1st to 3rd ¶¶) have been fully considered but not found persuasive for reasons set forth in the rejection above.
Retroactive construction of a generic claim that is not implicitly, inherently, or literally supported by the as-filed disclosure violates the written description requirement: As explained above, it is the Examiner’s understanding that Applicant is attempting to retroactively recreate a novel genus, heretofore unseen on record, by utilizing Example 1 as a starting point and then attempting to broaden the scope of the Example, in a piecemeal fashion (see, e.g., Reply filed 11/18/2025 at 6 at 1st to 3rd ¶¶, 6 at § “35 U.S.C. § 112” to p. 16 at final ¶). This attempt to retroactively create a synthetic genus that was not inherently, implicitly, or literally disclosed by the originally filed disclosure is insufficient to satisfy the requirements of 35 USC § 112(a). The courts have addressed attempts to retroactively create a genus or subgenus by cobbling together various portions of a disclosure (see, e.g., In re Smith (458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972), noting that “[w]hatever may be the viability of an inductive-deductive approach to arriving at a claimed subgenus, it cannot be said that such a subgenus is necessarily described by a genus encompassing it and a species upon which it reads"). Furthermore, courts have clearly stated that the mere disclosure of “each ... individual limitations” separately and distinctly, does not evidence possession of all combinations of all such limitations “as an integrated whole” because written description support requires more than the combination of “an amalgam of disclosures plucked selectively from the ... application” (see, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”). Here, the selective inclusion and selective exclusion of particular combinations of limitations set forth in the laundry list disclosure of possibilities in the originally filed disclosure in order to arrive at a narrower genus of species that was not reasonably or specifically identified or described “as an integrated whole” in the originally filed disclosure is a violation of the written description requirement.
In sum, attempts to retroactively create a novel genus that is not literally, implicitly, or inherently disclosed anywhere within the originally filed disclosure, wherein the genus fails to utilize synonymous or equivalent terminology set forth in the originally filed disclosure, and wherein the novel genus is created on the basis of hypothetical generalizations of various components of Example 1 premised upon what an artisan would or would not have found “obvious”, is not sufficient to satisfy the requirements of 35 USC 112(a) because it does not reflect US patent law as explained above.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive. Therefore, no claims are allowed. All new or revised rejections were necessitated by Applicant’s amendments.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
German4 pertains to mechanistic aspects of dopamine. Specifically, in view of German, an artisan would readily understand that the brain is a “drug delivery circuit” that “converts continuous biological signals into detectable signals or binary digits” (see, e.g., Spec. filed 3/17/2021 at 12 at line 25 to page 13 at line 4), wherein neurons comprise a “plurality of activatable drug delivery agents” (see, e.g., Spec. filed 3/17/2021 at 17 at lines 5-20), namely dopamine-loaded vesicles (see, e.g., German at Fig. 1 on 1007), and wherein neurons comprise a “plurality of biocomparators”, namely either dopamine receptors or dopamine transporters (see, e.g., German at Fig. 1 on 1007, Fig. 2 on 1008, Fig. 3 on 1011, 1017 at col I at § 3 “Dopamine Receptors”) because such receptors (or transporters) are “compound[s] that detects an input biological signal and compare[] it to a stored reference signal” (see, e.g., Spec. filed 3/17/2021 at 12 at lines 15-20), specifically, wherein the stored reference signal may be arbitrarily considered “unbound” and a binding event may be arbitrarily deemed a compared “input biological signal” compared to the unbound state.
Linder5 identifies that iron is naturally stored, transported, and released from ferritin particles (see, e.g., Linder at title, abs). The Ferritin Pathway includes a “plurality of biocomparators” that comprise a “peptide cage surrounding a core” that comprises an activator, namely the plurality of hollow ferritin particles that each constitute peptide cages made of ferritin polypeptides, wherein the ferritin particles store iron (see, e.g., Linder at title, abs, 2024 at § 2, Fig. 1 on 4041), wherein iron constitutes an “activator” since it is required for the activity of erythrocyte hemoglobin, cardiac muscle myoglobin, cytochromes in the electron transport system of mitochondria, and various enzymes such as transferrin, ferroxidase, ferroportin, etc., etc. (see, e.g., Linder at 4023-4024 at bridging ¶, Fig. 1 on 4041). Linder informs artisans that organisms include at least hemoglobin, myoglobin, cytochromes, and various enzymes activatable with iron (see, e.g., Linder at 4023-4024 at bridging ¶, Fig. 1 on 4041). Linder identifies that ferritin is degraded via lysosomal proteases, which releases the activator of iron (see, e.g., Linder at 4028 at §§ 3.2 and 3.2.1), wherein the “threshold level of a given input” would be readily understood to be the pH of lysosomes required for optimal activity of proteases (see, e.g., Linder at 4028 at 2nd ¶).
US2013/0330766A1 (cited in previous action) is pertinent to a previously claimed term, namely “peptide lock”. US’766 utilizes the term “peptide lock” (see, e.g., US2013/0330766A1 at Fig 8(a), ¶[0020]), which does not refer to structures that comprise polyglutamic acid (see id).
Wei6 explains that liposomes are not “biologically inert” since they interact with cells, lipases, etc. (see, e.g., Wei at title, abs, passim), which was a relevant issue earlier in prosecution.
US5576016 (cited in previous action) uses the term to refer to a “solid lipid core” present in “emulsomes”, which are distinguished from liposome (see, e.g., US’016 at col 2 at lines 47-55). This is pertinent because “lipid core” was previously a term utilize in the claims.
US20020133225A1 (cited in previous action) identifies that a “lipid core” is part of a nanocapsule rather than a liposome (see, e.g., US’225 at ¶[0053]). This is pertinent because “lipid core” was previously a term utilize in the claims.
US6379683 (cited in previous action) identifies that a “lipid core” is part of a nanocapsule rather than a liposome (see, e.g., US’683 at claim 1). This is pertinent because “lipid core” was previously a term utilize in the claims.
US20170313765A1 (cited in previous action) identifies that a “lipid core” is part of a “lipid nanoparticle (LNP)” (see, e.g., US’765 at ¶[0091]). This is pertinent because “lipid core” was previously a term utilize in the claims.
Wasserman7 (cited in previous action) identifies that a “lipid core” is a medical term utilized to define carotid plaques and similar structures (see, e.g., Wasserman at title, abs, 329 at col I., Fig. 2 on 331). This is pertinent because “lipid core” was previously a term utilize in the claims.
US4957729A (cited in previous action) identifies that a “lipid core” may be part of an emulsion (see, e.g., US’729 at claim 4). This is pertinent because “lipid core” was previously a term utilize in the claims.
US20040204354A1 (cited in previous action) identifies that a “lipid core” may be part of a low-density lipoprotein carrier particle (see, e.g., US’354 at title, abs, claims 1, 22, 23, and 34). This is pertinent because “lipid core” was previously a term utilize in the claims.
Truffi8 pertains to a a ferritin nanocage (see, e.g., Truffi at title, abs, Fig. 1 on 59, Fig. 2 on 61, Fig. 3 on 62, Fig. 4 on 62). This is pertinent because the claims previously recited a “peptide cage”.
Fouladi9 discusses enzyme-responsive liposomes for the delivery of anticancer drugs (see, e.g., Fouladi at title, abs), wherein an enzyme can be used to release cargo contained within the liposome (see id) and wherein the liposome can comprise cleavable peptides, which must be cleaved to activate and release the contents of the liposome (see, e.g., Fouladi at Fig. 6 on 861, Fig. 7 on 862, 862 at col II, Fig. 8 on 863, Fig. 9 at 864). ). This is pertinent because the claims previously recited a “peptide cage”.
Aumiller10 identifies that peptide “cages” are typically utilized in the art to refer to specific families of self-assembling peptides such as VLPs, ferritins, chaperonins, and heat shock proteins that form complete “cages” encompassing a hollow core suitable for holding other chemical agents (see, e.g., Aumiller at title, abs, 3433 at § 1, 3434 at col II at 1st full ¶, Fig. 1 on 3435, Figs. 2-3 on 3436, Fig. 16 on 3447, Fig. 17 on 3448, Fig. 22 on 3453). This is pertinent because the claims previously recited a “peptide cage”.
Conclusion
Claims 1 and 38-42 are rejected. 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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 No claim interpretation set forth in the Requirement mailed 11/13/2023 (see Requirement at pages 2-6) was disputed in the Reply filed 3/12/2024.
2 ] See, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”.
3 ] See, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”.
4 See, e.g., German et al., Regulation of the Dopamine and Vesicular Monoamine Transporters: Pharmacological Targets and Implications for Disease. Pharmacol Rev. 2015 Oct;67(4):1005-24. doi: 10.1124/pr.114.010397. PMID: 26408528; PMCID: PMC4630566; cited in previous action.
5 Linder MC. Mobilization of stored iron in mammals: a review. Nutrients. 2013 Oct 10;5(10):4022-50. doi: 10.3390/nu5104022. PMID: 24152745; PMCID: PMC3820057; hereafter “Linder”. Cited in previous action.
6 See, e.g., Wei et al, Cationic nanocarriers induce cell necrosis through impairment of Na+/K+-ATPase and cause subsequent inflammatory response. Cell Res 25, 237–253 (2015). https://doi.org/10.1038/cr.2015.9; cited in previous action; hereafter “Wei”, at title, abs; cited in previous action.
7 Wasserman et al., Risk factor associations with the presence of a lipid core in carotid plaque of asymptomatic individuals using high-resolution MRI: the multi-ethnic study of atherosclerosis (MESA). Stroke. 2008 Feb;39(2):329-35. doi: 10.1161/STROKEAHA.107.498634. Epub 2008 Jan 3. PMID: 18174475; hereafter “Wasserman”; cited in previous action.
8 Truffi M, Fiandra L, Sorrentino L, Monieri M, Corsi F, Mazzucchelli S. Ferritin nanocages: A biological platform for drug delivery, imaging and theranostics in cancer. Pharmacol Res. 2016 May;107:57-65. doi: 10.1016/j.phrs.2016.03.002. Epub 2016 Mar 9. PMID: 26968122; hereafter “Truffi”; cited in previous action.
9 Fouladi F, Steffen KJ, Mallik S. Enzyme-Responsive Liposomes for the Delivery of Anticancer Drugs. Bioconjug Chem. 2017 Apr 19;28(4):857-868. doi: 10.1021/acs.bioconjchem.6b00736. Epub 2017 Mar 8. PMID: 28201868; PMCID: PMC5509414; cited in previous action.
10 Aumiller WM , Uchida M , Douglas T . Protein cage assembly across multiple length scales. Chem Soc Rev. 2018 May 21;47(10):3433-3469. doi: 10.1039/c7cs00818j. PMID: 29497713; PMCID: PMC6729141; hereafter “Aumiller; cited in previous action.