DETAILED ACTION
Receipt of Arguments/Remarks filed on May 18 2026 is acknowledged. Claims 3, 5-10, 12, 14, 17-18, 21-22, 25, 27-32, 34-36 and 40 were/stand cancelled. Claims 1 and 23 were amended. Claims 41-42 were added. Claims 1-2, 4, 11, 13, 15-16, 19-20, 23-24, 26, 33, 37-39 and 41-42 are pending. Claims 23-24, 26, 33 and 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 25 2025. Claims 1-2, 4, 11, 13, 15-16 , 19-20 and 41-42 are directed to the elected invention.
The examiner notes that new claim 41 is interpreted as limiting the combination antiviral therapeutic agents present to only be dolutegravir, lamivudine and tenofovir disoproxil fumarate. That is other antiviral therapeutic agents are excluded. This results in claim 42 as further limiting claim 41 which recites the combination of antiviral therapeutic agents comprising which would allow for other antiviral therapeutic agents to be present.
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 .
Priority
Applicants arguments filed May 18 2026 have been considered. Applicants argue that claim 1 of the provisional application includes the same language as the instant claims. While the provisional fails to actually provide written description for the claimed x-ray diffraction for the reasons set forth below and does not refer to Yu et al., Applicants are correct that the words from the claims are present in the provisional application. Therefore, the effective filing date of the instant claims Is January 9 2020.
Specification/Incorporation by Reference
The attempt to incorporate subject matter into this application by reference Yu et al. (J Pharm Sci 2020 Nov 109(11): 3480-3089) (page 17) is ineffective because it refers to a Non-Patent Literature to incorporate essential subject matter, specifically subject matter required to provide support under 112a written description.
While this portion of the specification clearly provides reference to the root words “incorporate” and “reference” and the reference is clearly identified. The reference is non-patent literature. 37 CFR 1.57(c) make it clear that essential subject matter may be incorporated by reference, but only by way of an incorporation by reference to a US Patent or US Patent application number. Essential material is that which provides written description of the invention.
This section of the instant specification also is not specific with regards to the subject matter to be incorporated. Page 17 recites “in its entirety” which is not sufficient to permit incorporation of material not specifically identified in the incorporation statement. The only specifically identified information is MDM structures.
See MPEP 608.01(p); In re Saunders, 444 F.2d 599, 170, USPTQ 213 (CCPA 1971); Advanced Display Systems, Inc. v. Kent State Univ., 212 F.3d 1272, 54 USPQ2d 1673 (Fed. Cir. 2000).
The incorporation by reference will not be effective until correction is made to comply with 37 CFR 1.57(c), (d), or (e). If the incorporated material is relied upon to meet any outstanding objection, rejection, or other requirement imposed by the Office, the correction must be made within any time period set by the Office for responding to the objection, rejection, or other requirement for the incorporation to be effective. Compliance will not be held in abeyance with respect to responding to the objection, rejection, or other requirement for the incorporation to be effective. In no case may the correction be made later than the close of prosecution as defined in 37 CFR 1.114(b), or abandonment of the application, whichever occurs earlier.
Any correction inserting material by amendment that was previously incorporated by reference must be accompanied by a statement that the material being inserted is the material incorporated by reference and the amendment contains no new matter. 37 CFR 1.57(g).
Response to Arguments
Applicants’ arguments filed May 18 2026 have been fully considered but they are not persuasive.
Applicants argue that that each of the clauses characterizing the X-ray diffraction are specifically identified in the text of the specification. It is argued that the instant specification expressly details the X-ray diffraction pattern by strength of peak, peak position wherein this unified peak indicates repeating identical units and long-range order. It is argued that this language is sufficient on its face to establish that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. It is argued to avoid doubt about the meaning of these terms, the present application recites at paragraph 0076 which states that MDM structures are described, for example, in Yu et al. It is argued that this sentence identifies that such a structure is referred to as an MDM. Sentence two identifies an example in the literature. There is nothing in the Yu reference that Applicant relies upon as essential material. It is merely cited to demonstrate the state of the art.
Regarding Applicants’ argument, Yu et al. is cited to provide an example of what is meant by MDM. MDM, multiple drug domains, is expressly claimed. It is this reference that is being utilized to establish what this term means, to provide description of an x-ray diffraction pattern with a single peak having a signal to noise ratio of greater than 3 as none of these are actually described in the instant specification with sufficient specificity to allow one skilled in the art to recognize this scope or to recognize how this “homogenous powder” characterized by a specific powder X-ray diffraction is achieved. Therefore, while these words are present in the specification, Applicants are still relying on Yu et al. to support essential subject matter which is specifically what is meant by multiple drug domains. Fig. 1 of Yu et al. clearly shows x-ray diffraction patterns of 1) the individual drugs and 2) the combination to show clearly how these are different. But none of this similar information is present in the instant specification especially with description over the scope of the claims with the variety of combination of antivirals claimed and the excipients claimed. Yu et al. appears to be critical to understand the instantly claimed multi-drug domains which means that Yu et al. is describing essential subject matter.
New and Modified Rejection Based on Amendments in the reply filed on May 18 2026
Claim Rejections - 35 USC § 112-Indefiteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4, 11, 13, 15-16 , 19-20 and 41-42 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 as amended is vague and indefinite. Claim 1 recites: “wherein the antiviral therapeutic agent nanoparticle powder is a homogeneous powder characterized by powder X-ray diffraction to be free of individual antiviral therapeutic agent signatures, be free of individual antiviral therapeutic agent signatures present in the individual antiviral therapeutic agents, have one peak having a single to noise ratio of greater than 3, and has a cohesive unified X-ray diffraction pattern representing multiple drug domains assembled in repeating units;”. However, the specification does not include any x-ray diffraction patterns nor describe what is meant by a cohesive unified x-ray diffraction pattern representing multiple drug domains assembled in repeating units. The specification (step 1, general procedure for making the aqueous dispersion, page 33) states similar language. This portion of the specification indicates that the MDM (multiple dug domains) can be different from that of amorphous x-ray diffraction presented typically as a broad halo with no single peak in the drug powder products. But still does not indicate what is meant by cohesive unified x-ray diffraction pattern. The examiner can find no evidence that this term is a term of the art. No other art discusses cohesive unified x-ray diffraction pattern. Nothing in the instant specification indicates what the x-ray diffraction (i.e. the identification of any peak) associated in the composition such that the metes and bounds of the claim are clearly discernible. As implied by the statement in the claims, the x-ray diffraction pattern would not be the same as the individual therapeutic agent. Therefore, there must be some change in the x-ray diffraction pattern upon forming the composition. But neither the claims nor the specification indicate the boundaries for determining that the x-ray diffraction pattern is free of individual antiviral therapeutic agent signatures.
The instant specification (page 37) indicates that after solvent removal, the formation of stable DcNP powder could be verifiable by X-ray diffraction pattern of the powder. Instead of formation of halo or broad scan across x-ray angle, which reflect the amorphous powder product or crystalline peaks for each drug in the mixture, the DcNP powder exhibited a unique and unified peak for all drugs in the mixture plus the two lipid excipients. So does that mean that any x-ray diffraction pattern that isn’t a halo or broad scan is sufficient to say the powder x-ray diffraction is free of individual antiviral therapeutic agent signatures and has a cohesive unified x-ray diffraction pattern? The specification never clearly indicates what is the “unique and unified peak”.
Claim 1 as amended and new claim 41 is vague and indefinite. The claim recites the antiviral therapeutic agent nanoparticle powder is a homogeneous powder characterized by powder X-ray diffraction to: be free of individual antiviral therapeutic agent signatures, be free of individual antiviral therapeutic agent signatures present in the individual antiviral therapeutic agents. It is unclear how the “be free of” in the two instances are different. Both are referring to the X-ray diffraction being free of individual antiviral therapeutic agent signature. However, the second recitation additionally states “in the individual antiviral therapeutic agents”. But this doesn’t explain what makes those signatures different that the individual antiviral therapeutic agent signatures referred to in the first recitation.
Claims 2, 4, 11, 13, 15-16, 19-20 and 42 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
Response to Arguments
Applicants’ arguments filed May 18 2026 have been fully considered but they are not persuasive.
Applicants argue that to be free of something means that thing to be absent or not included. It is the described structure of the x-ray diffraction pattern that is assigned the moniker multiple drug domains assembled in repeating units. One skilled in the art would have no issue examining x-ray diffraction patterns and determining whether it meets the characteristics set out in claim 1.
Applicants arguments are not persuasive. Firstly, claim also states that the powder has a cohesive unified X-ray diffraction pattern. None of the argument explain what this term means. The application is utilizing this X-ray diffraction pattern in an attempt to distinguish the instant claims from the prior art. However, nothing in the specification or the arguments explains what the X-ray diffraction pattern actually looks like beside there is at least one peak (located anywhere) that has a single to noise ratio of greater than 3. While the examiner does not disagree that to be free of something means that thing to be absent or not included, what is unclear is what the signatures to make that determination. For example, Applicants argue that Yu et al. describes the state of the art.
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As shown in the figure there is a single peak in (i) but those x-ray diffraction patterns of the individual drugs also have peaks in a similar area, see for example a), b) and c). While there are more peaks, Applicants argue free of means absent or not included, but the single peak in (i) appears to be of the same or similar intensity to at least (b) and at the same degree. Thus, again, how does one make the determination that the x-ray diffraction pattern is free of individual signatures when free means absent or not included. Since the instant specification fails to show the x-ray diffraction pattern (either in picture or words) of the individual agents and then the x-ray diffraction pattern for the combination and explain how the determination that the pattern is 1) free of individual antiviral therapeutic agent signatures and 2) have a cohesive unified X-ray diffraction pattern, the examiner cannot agree that one skilled in the art would be apprised of the scope. The metes and bounds of the claim must be clear. Therefore, it must be clear to one skilled in the art when comparing two different X-ray diffractions patterns what peaks can and cannot be present in order to fall within the scope of the x-ray diffraction pattern instantly claimed.
Claim Rejections - 35 USC § 112-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 1-2, 4, 11, 13, 15-16, 19-20 and 41-42 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.
Claim 1 recites: “wherein the antiviral therapeutic agent nanoparticle powder is a homogeneous powder characterized by powder X-ray diffraction to be free of individual antiviral therapeutic agent signatures, be free of individual antiviral therapeutic agent signatures present in the individual antiviral therapeutic agents, have one peak having a signal to noise ratio of greater than 3 and have a cohesive unified X-ray diffraction pattern representing multiple drug domains assembled in repeating units;”. However, the instant specification never provides written description on the x-ray diffraction, the structure on how to achieve an x-ray diffraction with at least one peak with a signal to noise ratio greater than 3 and what is meant by the recitation free of individual antiviral therapeutic agent signature and a cohesive unified x-ray diffraction pattern representing multiple drug domains assembled in repeating units.
Page 34 of the instant specification shows how powder x-ray diffraction was performed. This section of the specification teaches that: The two lipid excipients- 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and 1,2-distearoyl-sn-glycero-3- phosphoethanolamine-N-[poly (ethylene glycol)2000] (mPEG20oo-DSPE); as well as all the active pharmaceutical ingredients or drugs- Dolutegravir (DTG) , Efavirenz (EFV), Lopinavir (LPV), Ritonavir (RTV), Atazanavir (ATV); Lamivudine (3TC or L), Tenofovir (TFV) and its prodrug Tenofovir disoproxil fumarate (TDF) and Tenofovir alafenamide (TAF), Emtricitabine (FTC)-all exhibited unique identifiable crystalline peak characteristic each on XRD scan profile over the 2-50 degree 2Θ. However, the specification never describes what these unique identifiable crystalline peak characteristics are so that one skilled in the art would readily understand what peaks would need to be absent to fall within the scope of the instant claims.
The instant specification (page 37) indicates that after solvent removal, the formation of stable DcNP powder could be verifiable by X-ray diffraction pattern of the powder. Instead of formation of halo or broad scan across x-ray angle, which reflect the amorphous powder product or crystalline peaks for each drug in the mixture, the dcNP powder exhibited a unique and unified peak for all drugs in the mixture plus the two lipid excipients. No where in the specification is the unique and unified peak for the drugs in the mixture described. Nor does the specification describe where the at least one peak having a signal to noise ratio of greater than 3 is located.
Therefore, the specification establishes that the x-ray diffraction is unique but never identifies what the x-ray diffraction looks like.
MPEP 2163 states that (emphasis added):
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612.
As set forth above, the instant specification teaches that the dcNP powder exhibited a unique and unified peak for all drugs in the mixture but the specification never described what is that unique and unified peak.
The state of the art, see Caira for example, teaches that x-ray diffraction is a technique for solid-sate characterization and is able to provide a unique pattern for any given crystalline phase. The pattern generated represents a “fingerprint” of the phase in question (introduction). The x-ray diffraction pattern (PXRD) technique is used extensively in the identification of multi-component compounds and increasingly in the context of the characterization of new pharmaceutically relevant phases that might display advantageous properties, such as enhanced solubility of the active pharmaceutical ingredient (API). Following co-grinding of an equimolar mixture of two components in the presence of chloroform for 10 minutes, the PXRD pattern of the product was recorded; this pattern differs significantly from those of the components, indicating probable formation of a binary compound, a salt or a co-crystal being the most likely products (multi-component compounds). Heating solid APIs, or multi-component compounds containing APIs, generally induces reactions and phase transitions such as loss of solvent of crystallization (for solvated materials), conversion of one polymorphic form to another, transformation of amorphous phases to crystalline phases, fusion and thermal decomposition (variable temperature pxrd).
Therefore, the state of the art establishes that how the composition is made has an effect on the resulting x-ray diffraction pattern and the x-ray diffraction pattern provides a way to identify compounds in a multi-component composition.
Since the specification teaches the x-ray diffraction exhibits a unique and unified peak and Caira recognizes that the ways the components are combined as well as heating can result in differences in the x-ray diffraction pattern, the specification fails to provide written description for the scope of the powder claimed. The response filed August 14 2025 alleges the instantly claimed product possesses an unexpected effect compared to the prior art. The claimed “multiple drug domain” structure as claimed is only ever taught in the art by Applicant. It is this structure and the X-ray diffraction that applicant is utilizing in an attempt to distinguish the instantly claimed structure from the prior art. Therefore, written description support of what the x-ray diffraction as claimed is as well as how it is achieved is required. Nothing in the specification provides any specific description, for example specific intensities, nor does the specification show any x-ray refraction pattern data to allow one skilled in the art to recognize applicants were in possession of the claimed invention.
Response to Arguments
Applicant’s arguments filed May 18 2026 have been fully considered but they are not persuasive.
Applicant argue (page 9 or remarks, page 16 of the response) that that the X-ray diffraction pattern is highlighted at paragraph 0076 of the published application. It is argued that this portion of the specification provides a detailed discussion that makes the language in the claims both definite and comply with the written description. This section also incorporates by reference to Yu which illustrates the state of the art in the field.
Regarding Applicant’s arguments, firstly, as set forth above, Yu does not establish the state of the art with regards to determining that an x-ray diffraction pattern is “free of” individual antiviral therapeutic agent signatures. As shown in the figure below, there is a single peak in (i) but those x-ray diffraction patterns of the individual drugs also have peaks in a similar area, see for example a), b) and c). While there are more peaks, Applicants argue free of means absent or not included, but the single peak in (i) appears to be of the same or similar intensity to at least (b) at the same degree. Thus, again, how does one make the determination that the x-ray diffraction pattern is free of individual signatures when free means absent or not included. Since the instant specification fails to show the x-ray diffraction pattern (either in picture or words) of the individual agents and then the x-ray diffraction pattern for the combination and explain how the determination that the pattern is 1) free of individual antiviral therapeutic agent signatures and 2) have a cohesive unified X-ray diffraction pattern, the examiner cannot agree that one skilled in the art would be apprised of the scope.
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Looking to Yu, while there are X-ray diffraction patterns show which recite a single large peak (Figure 1i) which could be said to have a signal to noise ratio of 3 (the reference does not expressly state this but assuming the noise is 1000 and the peak is 3000 this is a ratio of 3). This is for a specific combination of LPV (lopinavir), RTV (ritonavir), TFV (tenofovir) and 2 lipid excipients DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) and DSPE-PEG2000
(1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[amino(polyethylene glycol)-2000]). Yu et al. teaches that controlled solvent removal by spray drying is a critical step in locking these constituents together (page 3481, right column, 2nd complete paragraph). Therefore, Yu teaches an x-ray diffraction pattern with a single peak (not at least one as claimed), a ratio of 3 (not greater than 3 as claimed) and for a specific combination of drug (which is not claimed) and a combination of 2 specific lipids (not one or more as claimed). While variant-6 shows that the combination of lamivudine/tenofovir/dolutegravir (reading on (i) in claim 1) forms a multi-drug-motif structure. Nothing in Yu et al. supports that any multi-drug motif necessarily has the x-ray diffraction as claimed. A single x-ray diffraction is not representative of the full scope. Furthermore, Yu et al. suggests the criticality with regards to controlled spray-drying. However, example 1 states that the solvent can be removed by spray drying or lyophilization. Iwamoto et al. (WO2016205384) previously cited claims that the solvent is removed by evaporating, desiccating under reduced pressure, spray drying or a combination thereof (see claim 48). Example 5 of Iwamoto et al. expressly states “controlled removal of solvent to form a dry product”. But Applicant argued the results, specifically the plasma half-life, is different for Iwamoto than the instant claims (see remarks filed August 14 2025, pages 11-12). The instant specification does not make clear how a different structure is formed in the instant application when compared to the prior art, especially in light of the same drugs, same lipid excipients and same solvent removal (spray drying) being utilized. The claims include an x-ray diffraction pattern which is not expressly taught by Iwamoto. Nothing in Yu et al. establishes that structural or process of making would necessarily form the x-ray diffraction claimed over the full scope of the claims. Therefore, the examiner cannot agree that paragraph 0076 or Yu et al. provide the appropriate written description support for the claimed homogeneous powder characterized by a powder X-ray diffraction to be free of individual antiviral therapeutic agent signatures and have one peak having a signal to noise ratio of greater than 3 while also exhibiting a therapeutically effective plasma concentration of the combination of antiviral therapeutic agents for 2 or more weeks
While the instant specification utilizes the words present in the claim, these words are not sufficient to establish written description support for the actual X-ray diffraction pattern. As established in Caira, x-ray diffraction is a technique for solid-sate characterization and is able to provide a unique pattern for any given crystalline phase. Thus, the mere presence of the words are not sufficient to provide for the unique pattern which would be representative of the claimed x-ray diffraction, even the x-ray diffraction of claim 41 which requires free of individual antiviral therapeutic agent signatures and one peak with a signal to noise ratio of greater than 3, especially in light Caira teaching that the ways the components are combined as well as heating can result in differences in the x-ray diffraction pattern. Since Applicants have argued an unexpected effect with regards to the instantly claimed composition, then written description support must be presented which describes how such a composition which possess these unexpected properties is formed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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