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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/9/2025 has been entered.
Election/Restrictions
Claim 25, 27, 33, 35, 38, 40-43, and 45 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and III, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 9/11/2024.
However, as stated in the CTNF of 10/15/2024 and 6/11/2025, the requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Withdrawn: 13, 22, 25, 27, 33, 35, 38, 40-43, 45
Cancelled: 5, 6, 8, 10, 11, 14-21, 23-24, 26, 28-32, 34, 36, 37, 39, 44, 46-49
New: 51
Examined Herein: 1-4, 7, 9, 12, 50, 51
Priority
Priority to GB1818517.3 filed on 11/13/2018 and PCT/GB2019/053218 filed on 11/13/2019 is
acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/27/2021 and 7/26/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
statement is being considered by the examiner.
Drawings
The drawings filed on 5/13/2021 are accepted.
Withdrawn Rejections
The rejection of claims 1, 2, 3, and 12 under 35 U.S.C. 103 over Alonso-Fernandez, Duramad, and Kato are hereby withdrawn in view of Applicant’s amendments to claim 1, which replaces chitosan with chitosan HCl. [Remarks 12/9/2025, Page 8-11]
The rejection of claims 1, 2, and 9 under 35 U.S.C. 103 over Jon and Duramad are hereby withdrawn in view of Applicant’s amendments to claim 1, which replaces chitosan with chitosan HCl. [Remarks 12/9/2025, Page 11]
The rejection of claims 4 and 50 under 35 U.S.C. 103 over Alonso Fernandez, Duramad, Kato, and Trottein are hereby withdrawn in view of Applicant’s amendments to claim 1, which replaces chitosan with chitosan HCl. [Remarks 12/9/2025, Page 12]
The rejection of claims 4, 7, and 50 under 35 U.S.C. 103 over Alonso Fernandez, Duramad, Kato, Trottein, and Dhere are hereby withdrawn in view of Applicant’s amendments to claim 1, which replaces chitosan with chitosan HCl. [Remarks 12/9/2025, Page 12]
Claim Objections
Claim 4 objected to because of the following informalities:
Claim 4 recites the term “absorbed.” However, in the context of the claim, it appears that the intended term is “adsorbed.” Applicant is advised to review the claim language for accuracy. To the extent that “adsorbed” is the intended term, appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Galli (US 2008/0199487 A1, Published 8/21/2008), in view of Jayakrishnan (US 2010/0260845 A1, Published 10/14/2010).
With respect to claim 1, Galli discloses a nanoparticle comprising a polymer, N.meningitidis serogroup C (MenC) capsular saccharide and α-Galactosylceramide (α-GalCer). [Galli, 0168]
Galli discloses the nanoparticle further comprises CRM197 mutant of diphtheria toxin (CRM). [0168] Galli discloses the nanoparticle may further comprise a bioadhesive or mucoadhesive including chitosan or derivatives thereof. [Galli, 0114]
With respect to claim 2, Galli discloses the nanoparticle may comprise a synthetic polymer, PLGA. [Galli, 0015]
With respect to claim 12, Galli discloses the nanoparticle may be in a buffered solution (histidine buffer or other pH buffering substances) or saline. [Galli, 0125 and 0093]
Galli does not disclose the nanoparticle comprises chitosan hydrochloride.
However, with respect to claim 1 and 3, Jayakrishnan discloses that chitosan hydrochloride is a chitosan derivative and a bioadhesive. [Jayakrishnan, 0034, 0042] Chitosan hydrochloride is a water-soluble chitosan.
Modifying the nanoparticle disclosed by Galli by adding chitosan results in the nanoparticle of claim 1 and 3.
Further modifying the nanoparticle disclosed by Galli and Jayakrishnan by adding PLGA results in the nanoparticle of claim 2.
Further modifying the nanoparticle disclosed by Galli and Jayakrishnan by adding a buffered solution or saline results in the nanoparticle of claim 12.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli by adding chitosan hydrochloride to the nanoparticle and have a reasonable expectation of success. Galli discloses a nanoparticle composition, which may further comprise a bioadhesive or mucoadhesive, including chitosan or derivatives thereof. Jayakrishnan discloses that chitosan hydrochloride is a chitosan derivative and a bioadhesive. Accordingly, the combined teachings of Galli and Jayakrishnan suggest that chitosan hydrochloride may function as the bioadhesive, chitosan derivative added to the nanoparticle composition disclosed by Galli. Therefore, it is reasonable to expect the nanoparticle disclosed by Galli may be modified by adding chitosan hydrochloride. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Galli discloses chitosan and derivatives thereof are adjuvants that function as immunoregulatory agents. [Galli, 0095, 0114] Therefore, one would have been motivated by the expectation that chitosan hydrochloride would impart its bioadhesive immunomodulating properties on the nanoparticle composition disclosed by Galli.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli and Jayakrishnan by adding PLGA to the nanoparticle and have a reasonable expectation of success. Galli and Jayakrishnan disclose a nanoparticle composition. Galli discloses the nanoparticle may further comprise PLGA. In view of this express teaching by Galli, it is reasonable to expect the nanoparticle disclosed by Galli and Jayakrishnan may be modified by adding PLGA to the nanoparticle. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Galli discloses microparticles formed from PLGA are adjuvants that function as immunoregulatory agents. [Galli, 0095, 0115] Therefore, one would have been motivated by the expectation that PLGA would impart its immunomodulating properties on the nanoparticle composition disclosed by Galli and Jayakrishnan.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli and Jayakrishnan by adding a buffered solution or saline to the nanoparticle and have a reasonable expectation of success. Galli and Jayakrishnan disclose a nanoparticle composition. Galli discloses the nanoparticle may further comprise a buffered solution or saline. In view of this express teaching by Galli, it is reasonable to expect the nanoparticle disclosed by Galli and Jayakrishnan may be modified by adding a buffered solution or saline to the nanoparticle. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Galli discloses saline and pH buffering substances are pharmaceutically acceptable carriers useful for formulating the composition as an immunogenic composition or vaccine. [Galli, 0092, 0093] Therefore, one would have been motivated by the expectation that adding a buffered solution or saline to the nanoparticle could enable the composition disclosed by Galli and Jayakrishnan to be formulated into an immunogenic composition or vaccine.
Claims 1-3, 12, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Galli and Jayakrishnan, as applied to claim 1-3 and 12 above, and further in view of Lavik (US 2013/0316010 A1, Published 11/28/2013).
With respect to claim 1, Galli and Jayakrishnan disclose the teachings above.
Galli and Jayakrishnan do not disclose the PLGA comprises lactic acid and glycolic acid in a ratio of 75:25.
However, with respect to claim 51, Lavik discloses a microparticle composition comprising
PLGA that has a lactic acid to glycolic acid ratio of about 75:25. [Lavik, 0021] Lavik discloses the microparticle is optimized for an agent to be delivered, so that the hydrophobicity or hydrophilicity of the polymer and charge of the polymer maximizes loading of the agent. Moreover, Lavik discloses the microparticle releases an effective amount of an active agent for a period greater than 14 days to greater than 120 days in vivo. [Lavik, 0015]
Modifying the nanoparticle disclosed by Galli and Jayakrishnan so that the PLGA has a lactic acid to glycolic acid ratio of about 75:25 results in the nanoparticle of claim 1.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli and Jayakrishnan so that the PLGA has a lactic acid to glycolic acid ratio of about 75:25 and have a reasonable expectation of success. Galli and Jayakrishnan disclose a nanoparticle composition comprising PLGA and several antigens. Lavik discloses a PLGA microparticle that has a lactic acid to glycolic acid ratio of about 75:25. Accordingly, the combined teachings of Galli and Jayakrishnan suggest the PLGA present in the composition disclosed by Galli and Jayakrishnan may be modified so that it achieves a lactic acid to glycolic acid ratio of about 75:25. Therefore, it is reasonable to expect the nanoparticle disclosed by Galli and Jayakrishnan may be modified so that the PLGA has a lactic acid to glycolic acid ratio of about 75:25. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Lavik discloses the PLGA microparticle (lactic acid to glycolic acid - 75:25) is optimized for an agent to be delivered, so that the hydrophobicity or hydrophilicity of the polymer and charge of the polymer maximizes loading of the agent. Moreover, Lavik discloses the microparticle releases an effective amount of an active agent for a period greater than 14 days to greater than 120 days in vivo. [Lavik, 0015] Accordingly, one would have been motivated by the expectation that the PLGA microparticle could maximize loading of the antigens in the composition disclosed by Galli and Jayakrishnan and release an effective amount of the antigen for a desired period in vivo.
Claims 1-4, 7, 12, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Galli and Jayakrishnan, as applied to claims 1-3 and 12 above, and further in view of Trottein (US 2015/0374734 A1, Published 12/31/2015)
With respect to claim 1 and 2, Galli and Jayakrishnan disclose the teachings above.
Recall, Galli and Jayakrishnan disclose a nanoparticle comprising PLGA, chitosan hydrochloride, a-GalCer, MenC, and CRM.
With respect to claim 4, Galli and Jayakrishnan disclose the nanoparticle comprises an antigen, CRM. [Galli, 0168]
With respect to claim 7, Galli and Jayakrishnan disclose antigen is MenC. [Galli, 0168] However, Galli and Jayakrishnan disclose the nanoparticle may further comprise one or more of the following antigens from S. pneumoniae: PhtA, PhtD, Pht3, Phth, SpsA, LytB, LytC, LytA, Sp125, Sp101, Sp128, Sp130 and Sp133, [Galli, 0060, 0063]
Galli and Jayakrishnan do not disclose the antigen is adsorbed on a surface of the nanoparticle, and wherein the antigen is adsorbed on to the surface of the nanoparticle by van der waals or electrostatic interaction. Galli and Jayakrishnan do not disclose the antigen is conjugated to a surface of the nanoparticle.
However, with respect to claim 4, Trottein discloses a nanoparticle comprising (i) α-Galcer, (ii) a pathogen-derived antigen, and (iii) a targeting agent, and (iv) a polymer (e.g., PLGA and/or chitosan). [Trottein, 0015-0019, 0122] Trottein discloses the antigen and/or targeting agent may be physically coupled to the surface of the nanoparticle via non-covalent linkage, including electrostatic interactions. [Trottein, 0116]
With respect to claim 50, Trottein discloses the antigen and/or targeting agent may be physically coupled to the surface of the nanoparticle by chemically linking the antigen to the surface of the nanoparticle. [Trottein, 0116]
Modifying the nanoparticle disclosed by Galli and Jayakrishnan so that CRM is adsorbed on to the surface of the nanoparticle by electrostatic interaction results in nanoparticle of claim 4.
Further modifying the nanoparticle disclosed by Galli and Jayakrishnan by adding an additional antigen from S. pneumoniae (i.e., PhtA, PhtD, Pht3, Phth, SpsA, LytB, LytC, LytA, Sp125, Sp101, Sp128, Sp130 and Sp133) results in nanoparticle of claim 7.
Modifying the nanoparticle disclosed by Galli and Jayakrishnan so that CRM is conjugated to the surface of the nanoparticle by chemical linkage results in nanoparticle of claim 50.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli and Jayakrishnan so that CRM is adsorbed on to the surface of the nanoparticle by electrostatic interaction and have a reasonable expectation of success. Galli and Jayakrishnan disclose a nanoparticle comprising α-Galcer, MenC, CRM, PLGA, and chitosan HCl. Trottein discloses a nanoparticle comprising (i) α-GalCer, (ii) a pathogen-derived antigen, (iii) a targeting agent, and (iv) a polymer (e.g., PLGA and/or chitosan). Trottein further discloses the antigen and/or targeting agent may be physically coupled to the surface of the nanoparticle via electrostatic interactions. Thus, Trottein establishes that a nanoparticle comprising components (i)-(iv) may be formulated so that the antigen and/or targeting agent is physically coupled to the surface of the nanoparticle via electrostatic interactions. Accordingly, the combined teachings of Galli, Jayakrishnan, and Trottein suggest that the nanoparticle disclosed by Galli and Jayakrishnan, which comprises (i) a-GalCer, (ii) a pathogen-derived antigen, MenC, (iii) a targeting agent/carrier protein, CRM, (iv) and polymers, PLGA and chitosan HCl, may be formulated so that the antigen and/or targeting agent is physically coupled to the surface of the nanoparticle via electrostatic interactions. Therefore, it is reasonable to expect the nanoparticle disclosed by Galli and Jayakrishnan may be modified so that CRM is adsorbed on to the surface of the nanoparticle by electrostatic interaction. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Trottein discloses the nanoparticle, which is formulated so that the antigen and/or targeting agent is adsorbed on to the surface via electrostatic interactions, is useful either as an adjuvant in a vaccine composition, in preventing or treating cancer or infection disorders, or in preventing or treating autoimmune and inflammatory disorders such as asthma. [Trottein, 0027-0030] Therefore, one would have been motivated by the expectation that arranging the nanoparticle disclosed by Gilli and Jayakrishnan so that the antigen is adsorbed on to the surface via electrostatic interactions, could render the nanoparticle useful as an adjuvant in a vaccine composition, in preventing or treating cancer or infection disorders, or in preventing or treating autoimmune and inflammatory disorders such as asthma.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli, Jayakrishnan, and Trottein adding an antigen from S. pneumoniae (i.e., PhtA, PhtD, Pht3, Phth, SpsA, LytB, LytC, LytA, Sp125, Sp101, Sp128, Sp130 and Sp133) to the nanoparticle and have a reasonable expectation of success. Galli, Jayakrishnan, and Trottein disclose a nanoparticle composition. Galli discloses the nanoparticle may further comprise one or more of antigens from S. pneumoniae. In view of this express teaching by Galli, it is reasonable to expect the nanoparticle disclosed by Galli, Jayakrishnan, and Trottein may be modified by adding an antigen from S. pneumoniae (i.e., PhtA, PhtD, Pht3, Phth, SpsA, LytB, LytC, LytA, Sp125, Sp101, Sp128, Sp130 and Sp133) to the nanoparticle. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Galli discloses the use of compositions comprising saccharide antigens from S. pnuemoniae are known in the art to prepare pneumococcal vaccines. [Galli, 0042] Accordingly, one would have been motivated by the expectation that adding an antigen from S. pneumoniae to the composition disclosed by Galli, Jayakrishnan, and Trottein may enable the composition to be used to prepare a pneumococcal vaccine.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli and so that CRM is conjugated to the surface of the nanoparticle by chemical linkage and have a reasonable expectation of success. Galli and Jayakrishnan disclose a nanoparticle comprising a-GalCer, MenC, CRM, PLGA, and chitosan HCl. Trottein discloses a nanoparticle comprising (i) a-GalCer, (ii) a pathogen-derived antigen, (iii) a targeting agent, and (iv) a polymer (e.g., PLGA and/or chitosan). Trottein further discloses the antigen and/or targeting agent is conjugated to the surface of the nanoparticle by chemical linkage. Thus, Trottein establishes that a nanoparticle comprising components (i)-(iv) may be formulated so that the antigen and/or targeting agent is conjugated to the surface of the nanoparticle via chemical linkage. Accordingly, the combined teachings of Galli, Jayakrishnan, and Trottein suggest that the nanoparticle disclosed by Galli and Jayakrishnan, which comprises (i) a-GalCer, (ii) a pathogen-derived antigen, MenC, (iii) a targeting agent/carrier protein, CRM, (iv) and polymers, PLGA and chitosan HCl, may be formulated so that the antigen and/or targeting agent is conjugated to the surface of the nanoparticle via chemical linkage. Therefore, it is reasonable to expect the nanoparticle disclosed by Galli and Jayakrishnan may be modified so that CRM is conjugated to the surface of the nanoparticle by chemical linkage. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Trottein discloses the nanoparticle, which is formulated so that the antigen and/or targeting agent is conjugated to the surface by chemical linkage, is useful either as an adjuvant in a vaccine composition, in preventing or treating cancer or infection disorders, or in preventing or treating autoimmune and inflammatory disorders such as asthma. [Trottein, 0027-0030] Therefore, one would have been motivated by the expectation that arranging the nanoparticle disclosed by Gilli and Jayakrishnan so that the antigen and/or targeting agent is conjugated to the surface by chemical linkage, could render the nanoparticle useful as an adjuvant in a vaccine composition, in preventing or treating cancer or infection disorders, or in preventing or treating autoimmune and inflammatory disorders such as asthma.
Claims 1-3, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Galli and Jayakrishnan, as applied to claim 1-3 and 12 above, and further in view of Jon (US 2008/0268063 A1, Published 10/30/2008).
With respect to claim 1, Galli and Jayakrishnan disclose the teachings above.
With respect to claim 9, Galli discloses the nanoparticle may be prepared in a form suitable for pulmonary administration. [Galli, 0124] Galli further discloses the nanoparticles may be combined with one or more excipients. [Galli, 0093]
The limitation “wherein the dry powder format is produced by spray drying the nanoparticles” recites a product by process limitation, which is unpatentable even if the prior art product was made by a different process. MPEP 2113(I)
The limitation “suitable for inhalation” recites an intended use but does not impart a structural difference between the claimed invention and the prior art. Therefore, this limitation is not patentably distinguishable from the prior art. MPEP 2111.02
Galli and Jayakrishnan do not disclose the nanoparticle is in a dry powder format.
However, with respect to claim 9, Jon discloses a nanoparticle comprising a synthetic polymer, PLA-PEG-COOH, insulin, and chitosan. [Jon, Page 10, Table 1] Jon further discloses the nanoparticle is suitable for inhalation and may be prepared by spray-drying, which results in a dry powder format. [Jon, 0078-0079 and 0051]
Modifying the nanoparticle disclosed by Galli and Jayakrishnan by formulating the nanoparticle into a dry powder format results in the nanoparticle of claim 9.
It would be obvious to one of ordinary skill in the art to modify the nanoparticle disclosed by Galli and Jayakrishnan by formulating the nanoparticle into a dry powder format and have a reasonable expectation of success. Galli and Jayakrishnan disclose a nanoparticle composition. Galli discloses the nanoparticle may be prepared in a form suitable for pulmonary administration. Jon discloses a nanoparticle composition that is in dry-powder format and suitable for inhalation (a type of pulmonary administration. Accordingly, the combined teachings of Galli, Jayakrishnan, and Jon suggest the nanoparticle disclosed by Galli and Jayakrishnan may be formulated in a dry-powder format, which is suitable for pulmonary administration. Therefore, it is reasonable to expect the nanoparticle disclosed by Galli and Jayakrishnan may be modified by formulating the nanoparticle into a dry powder format. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Jon discloses a pharmaceutical composition administered via inhalation is not as susceptible as other routes (i.e., injection) to enzymatic degradation by proteases and other chemicals in the gastrointestinal (GI) tract or poor permeability through the skin or intestinal epithelial cells (enterocytes). [Jon, 0003] Accordingly, one would have been motivated by the expectation that formulating the nanoparticle disclosed by Galli and Jayakrishnan into a dry powder format renders the nanoparticle suitable for inhalation and less susceptible to enzymatic degradation by proteases and other chemicals in the GI or poor permeability through the skin or intestinal epithelial cells.
Response to Arguments
Applicant's arguments filed 12/9/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to Alonso-Fernandez, Duramad, Kato, Trottein, Jon, and Dhere are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. [Remarks 12/9/2025, Page 8, 9, 10, 11, and 12]
With respect to Applicant’s allegations of unexpected results:
Applicant asserts “…the claimed embodiments are patentable over the cited art at least due to unexpected results. In particular, the inventors of the present application demonstrated that by using chitosan hydrochloride in the nanoparticle composition, the immunogenicity of the nanoparticle composition can be increased, so as to achieve an increase in the immunostimulatory response in patient airways elicited by a vaccine delivered by such a nanoparticle composition…the inventors have utilized the immunostimulatory properties of a-GalCer in combination with the previously unknown immunostimulatory properties of chitosan hydrochloride to produce a nanoparticle composition with increased immunogenicity.” [Remarks 12/9/2025, Page 10, Paragraph 1]
Applicant’s arguments are not persuasive because the data relied upon by the Applicant fails to demonstrate that the claimed nanoparticle exhibits unexpectedly superior immunostimulatory properties. Figures 19, 20, and 26 of the specification demonstrate that multiple adjuvants, including other chitosan derivatives, achieve a similar increase in immunogenicity compared to a control comprising no chitosan. Even non-chitosan adjuvants, such as LPS, produce equal or greater increases in immunogenicity than chitosan HCl. The data demonstrates that the effects of chitosan HCl reflect a difference in degree rather than a difference in kind and are consistent with the general expectation that adjuvants enhance immune responses. Chitosan HCl’s ability to increase immunogenicity reflects an expected property of adjuvants, rather than an unexpected property of chitosan HCl itself.
Moreover, the immunostimulatory properties of chitosan HCl were already known in the art and the effects demonstrated by the Applicant were consistent with the understanding of a POSITA at the time of filing the instant invention. In fact, the effects of most of the adjuvants are contemplated at least by Galli, which discloses chitosan, chitosan derivatives, and LPS are all adjuvants that function as immunoregulatory agents. [Galli, 0095, 0105, 0114] Additionally, Singh (US 2005/0281843 A1, Published 12/22/2005) discloses that the mucosal delivery of bioadhesives, including mucoadhesive and mucoadhesive derivatives, in combination with an antigen enhances the immunogenicity of the antigen co-administered therewith. [Singh, 0008] Chitosan HCl is a known mucoadhesive. Accordingly, one of ordinary skill in the art would have reasonably expected chitosan HCl to enhance the immunogenicity of an antigen.
Therefore, Applicant has not provided sufficient evidence to demonstrate that the claimed invention exhibits actual unexpected results.
Applicant asserts “…a person skilled in the art would not have had any reason to expect this. There is no disclosure in the cited art that would suggest or teach that immunogenicity could be
improved by using a chitosan derivative of any kind. More specifically, there is no disclosure in the art that chitosan hydrochloride provides a benefit or improvement in immunogenicity when
such a nanoparticle composition is used.” [Remarks, 12/9/2025, Page 10, Paragraph 3]
Applicant’s arguments are not persuasive because the features that Applicant alleges the cited references fail to show (i.e., improvements in immunogenicity) are not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
Applicant’s assertion is not persuasive because, in view of the references cited above and the general knowledge available at the time of the effective filing date of the instant application, one of ordinary skill in the art would have reasonably expected that immunogenicity could be improved by using a chitosan derivative. This is evidenced at least by Galli and Trottein. Galli discloses that adjuvants, such as chitosan and derivatives thereof, function as immunoregulatory agents. [Galli, 0095, 0114] Trottein discloses that adjuvants are used to potentiate an immune response against an antigen and enhance the effectiveness of a pharmaceutical composition comprising an antigen. [Trottein, 0147, 0159] Therefore, Galli and Trottein both establish that adjuvants, such as chitosan HCl, enhance immune responses to an antigen, reflecting an ability to increase immunogenicity. Furthermore, it was well understood in the art at the time of the effective filing date that bioadhesives (e.g., chitosan HCl), used in combination with an antigen enhance the immunogenicity of co-administered antigen. [Singh, 0008] Accordingly, the effects of chitosan and derivatives thereof purported by the Applicant would have been reasonably expected by one of ordinary skill in the art.
Conclusion
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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