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 .
Response to Amendment
The amendment filed 15 May 2026 in which claims 1, 5-6, 10, 22, and 27were amended, claims 9, 15-21, 26, 31, and 32 were cancelled, and claims 33-35 were added has been entered.
Claims 1-8, 10-14, 22-25, 27-30, and 33-35 are under examination on the merits.
Specification
(Previous objection, withdrawn). Applicant’s amendment of the Specification submitted 15 May 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 17 February 2026.
Claim Objections
(Previous objection, withdrawn). Applicant’s amendment of claims 5 and 27 and cancellation of claims 26 and 31-32 submitted 15 May 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 17 February 2026.
Claim Rejections - 35 USC § 112(a)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 1-4, 7-14, 22-25, and 28-30 due to amendment of claims 1 and 22 and cancellation of claim 9). Claims 1-4, 7-14, 22-25, and 28-30 were 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. Applicant’s amendment to claims 1 and 22 and cancellation of claim 9 submitted 15 May 2026 have overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, maintained as to claim 6). Claim 6 is 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.
(New rejection, necessitated by addition of claim 35). Claim 35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claim 35 broadly encompasses an immunogenic composition comprising a peptide containing multiple epitopes that, upon administration to a mammal generates an immune response to the pathogen, including a neutralizing response, wherein the peptide contains Influenza proteins HA, NA, and M, a T cell epitope, and ALFQ. An immunogenic composition inherently requires the function of immune stimulation/modulation.
Instant claim 35 is rejected as lacking adequate support for any peptide containing epitopes of Influenza proteins HA, NA, and M stimulating a neutralizing antibody response.
While the instant claims are drawn to a genus that comprises innumerable permutations of any peptide containing epitopes of Influenza proteins HA, NA, and M, the Specification only discloses examples for which the peptide is obtained from species HA, NA, and M epitopes and examples that show neutralizing antibody responses only include FluPep 5906 and FluPep11, against H1N1 and H3N2. Thus, the Specification failed to provide sufficient examples of species within the broadly claimed genus.
Further, while the claims provide both a structure and a function, the Specification failed to draw a correlation between the two (i.e., there is no evidence that any peptide can still retain the ability to raise a neutralizing immune response against a related or unrelated Influenza strains). Moreover, no correlation has been made as to which sequences from which epitopes from which strains are required in order to achieve the claimed neutralizing effect (e.g., it is not clear if said antigens must only be derived from linear epitopes that elicit CD4 or CD8 responses, etc.). It is not clear what sequence on the N and C terminal ends is, or is not, required to ensure a neutralizing response, as the peptide may have multiple additional amino acids on each end. Lastly, the Specification does not establish any additional peptides from any other Influenza strain that appear to have the same neutralizing effect as claimed.
Thus, in view of the above, there would have been significant uncertainty as to which peptides from which influenza strain would be able to confer the claimed neutralizing function. In view of this uncertainty and lack of sufficient examples of the broadly claimed genera, the claims are rejected for lack of adequate description support.
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn due to amendment of claim 5). Claim 5 was 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. Applicant’s amendment to claim 5 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(New rejection, necessitated by addition of claim 35). The term “neutralizing cells” in claim 35 (line 3) have no art recognized meaning and Applicant did not provide sufficient definition in the Specification to support the claimed term. The claim is indefinite because it is unclear what is being claimed as the term is not defined in the Specification or has an accepted meaning in the art.
For the purposes of compact prosecution and applying art, “neutralizing cells” is being interpreted as “neutralizing antibodies”.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New amendment, necessitated by cancellation of claim 26). Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 26 has been cancelled, a claim cannot depend on a cancelled claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the purposes of compact prosecution and applying prior art, claim 27 was interpreted as “The composition of claim 25”.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
(New rejection, necessitated by addition of claims 33-34). Claims 33-34 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 33 and 34 do not further limit the claim as the immune response including neutralizing antibodies is inherent to the composition claimed in claims 1 and 22, respectively, requiring neutralizing antibodies to be part of the immune response does not change the structure of the composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the purposes of compact prosecution and applying prior art, claims 33-34 were interpreted as the immunogenic composition of claim 1 or claim 22, respectively.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claim 1-9, 11-14, 22-24, and 28-30 due to amendment to claims 1 and 22 and cancellation of claim 9). Claims 1-9, 11-14, 22-24, and 28-30 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer. Applicant’s amendment to claims 1 and 22 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claim 10 due to amendment to claim 1). Claim 10 was rejected under 35 U.S.C. 103 as being unpatentable over Fischer and further in view of Alving. Applicant’s amendment to claim 1 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 25-27 and 31 due to amendment of claim 22 and cancellation of claim 26 and 31). Claims 25-27 and 31 were rejected under 35 U.S.C. 103 as being unpatentable over Fischer. Applicant’s amendment to claim 22 and cancellation of claims 26 and 31 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claim 32 due to cancellation of the claim). Claim 32 was rejected under 35 U.S.C. 103 as being unpatentable over Fischer and further in view of Presnell. Applicant’s cancellation of claim 32 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(New rejection, necessitated by amendment to claim 1). Claims 1-8, 10-14, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer as and further in view of Alving.
Regarding claims 1 and 10, Fischer teaches a composite antigen comprising a peptide with a contiguous amino acid sequence derived from a plurality of antigenic epitopes of one or more pathogens that induces an immune response in a mammal that is protective against infection by the one or more pathogens and that one or more of the epitopes are composite epitopes (pg. 24, column 6, lines 27-49). Fischer further teaches the reference peptide sequences SEQ ID NOs: 6 (HA), 8 (NA), 13 (M), and 54 (HA) which correspond to instant SEQ ID NOs: 6 (HA), 8 (NA), 13 (M), and 55 (HA). Fischer further teaches that these sequences can be coupled (as seen in reference SEQ ID NO: 66, coupling SEQ ID NOs: 6 (HA), 54 (NA), and 8 (HA)) to create a vaccine against multiple epitopes, allowing for a more broadly protective immune response. Fischer also teaches that adding a T-cell stimulating epitope allows for a T-cell response to the vaccine (Description of the Invention). Fischer further teaches reference SEQ ID NO: 60 which corresponds to instant SEQ ID NO: 61 and that this epitope can be coupled to influenza M protein epitopes (SEQ ID NO: 47). Fischer also teaches that the peptide sequence can have any combination of M1, M2, HA, NA, PB1, or PB2 proteins (pg. 24 column 6, lines 28-49) and multiple M peptide sequences (SEQ ID NOs: 22-48).
It would have been prima facie obvious before the effective filing date of the invention for one or ordinary skill in the art to have used the separate teachings of Fischer for a peptide sequence comprising the Influenza peptides HA (REF SEQ ID NO: 6 and 54) and NA (REF SEQ ID NO: 8) with the M ( REF SEQ ID NO: 13) peptide sequence also taught by Fischer and the T-cell stimulating epitope further taught by Fischer (REF SEQ ID NO: 60) to create a single peptide sequence coupling REF SEQ ID NOs: 6, 8, 13, 54, and 60. Fischer provides motivation by teaching that vaccine against multiple epitopes allow for a more broadly protective immune response (Pg. 26, column 9, lines 64-67 and column 10, lines 1-21) and that the T-cell stimulating epitopes induce a T-cell response (Pg. 28, column 14, lines 6-20). One of skill in the art would have had reasonable expectation of success at combining both teachings of Fischer because they are all peptide sequences for immunogenic compositions with composite epitopes.
PNG
media_image1.png
348
704
media_image1.png
Greyscale
Fischer teaches that almost any adjuvant can be used with the immunogenic composition comprising a composite epitope (Pg. 28, column 14, lines 36-50). Fischer does not teach that the adjuvant is a liposome adjuvant or more specifically ALFQ. However, Alving teaches that the Army Liposome Formulation (ALF) family, including ALFQ, are safe and potent vaccine adjuvants that produce both a Th1 and Th2 response (Abstract and Pg. 7 section 4). The ALFQ adjuvant is the only family member that produces a balanced Th1 and Th2 response (Pg. 7 section 4).
It would have been prima facie obvious before the effective filing date of the invention for one or ordinary skill in the art to have combined the teachings of Fischer for an immunogenic composition comprising composite epitope peptides and an adjuvant with the teachings of Alving for the adjuvant ALFQ. Alving provides motivation by teaching that ALFQ produces a balanced Th1 and Th2 response compared to other adjuvants (Pg. 7 section 4). One of skill in the art would have had reasonable expectation of success at combining Fischer and Alving because they both teach vaccines.
Regarding claim 2, Fischer teaches that one or more of the antigenic epitopes are amino acid sequences of M2 (pg. 24, column 6, lines 27-49).
Regarding claim 3, Fischer teaches the composite sequence of reference SEQ ID NO: 8, which is a composite sequence of reference SEQ ID NO: 4 (an HA epitope) and reference SEQ ID NO: 5 (an HA epitope), making reference SEQ ID NO:8 a composite epitope that is a combination of two similar (HA) epitopes (pg. 24, column 6, lines 27-49, SEQ ID NO:8).
Regarding claim 4, Fischer teaches the composite sequence of reference SEQ ID NO: 66, which is a composite sequence or reference SEQ ID NOs: 6 (an HA epitope), 54 (an HA epitope), and 8 (an NA epitope), making reference SEQ ID NO: 66 a composite epitope that is a combination of two dissimilar (HA and NA) epitopes (pg. 24, column 6, lines 27-49, SEQ ID NO: 66).
Regarding claim 5, Fischer teaches the composite epitope of Instant SEQ ID NO: 9 (Reference SEQ ID NO: 9).
PNG
media_image2.png
179
554
media_image2.png
Greyscale
Regarding claim 6, Fischer teaches that the composite antigen includes one or more T-cell stimulating epitopes, including the diphtheria toxoid (Pg. 28, column 14, lines 6-20).
Regarding claim 7, Fischer teaches the T-cell stimulating epitope at the C-terminus of the peptide, reference SEQ ID NO: 47 contains an M2e epitope and the tetanus toxoid at the C-terminus of the peptide (QYIKANSKFIGITE), a T cell stimulating epitope (SEQ ID NO: 47).
PNG
media_image3.png
74
603
media_image3.png
Greyscale
Regarding claim 8, Fischer teaches multiple influenza viral epitopes (pg. 24, column 6, lines 27-49) and multiple T-cell stimulating epitopes (Pg. 28, column 14, lines 6-20).
Regarding claim 11, Fischer teaches that composition is protective against influenza virus (pg. 24, column 6, lines 27-49).
Regarding claim 12, Fischer teaches that the virus is Influenza A (pg. 24, column 6, lines 27-49, SEQ ID NO: 66).
Regarding claim 13-14, Fischer teaches that the composite antigen protects against Staphylococcus (Pg. 27, column 12, lines 25-40 and 51-67 and pg. 28, column 13, lines 1-6).
Regarding claims 33 and 35, Fischer teaches an immunogenic composition that comprises a peptide containing multiple epitopes of Influenza proteins HA, NA, and M and a T cell epitope that when administered produce an immune response in mammals (see claim 1).
The type of immune response induced by a certain immunogenic composition is an inherent property of that vaccine. Therefore, as the immunogenic composition was rendered obvious the types of antibodies induced are also obvious as the antibodies would naturally flow from the combination of Fischer and Alving. The production of neutralizing antibodies are inherent to the peptide used, Fischer teaches that the peptides lead to the production of antibodies (pg. 30, column 18, lines 10-23). Therefore, these properties are inherent to the immunogenic composition and as the immunogenic composition has been rendered prima facie obvious, so too, absent evidence to the contrary, are the immune responses induced by the immunogenic composition.
Fischer does not teach the adjuvant ALFQ. However, Alving teaches the liposome adjuvant ALFQ (see claim 1).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
(New rejection, necessitated by amendment to claim 22). Claims 22-25, 27-30, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer and further in view of Presnell and Alving.
Regarding claim 22, Fischer teaches an immunogenic composition comprising viral and/or bacterial nucleic acids that encode a peptide sequence of a pathogen, containing multiple epitopes, where at least one epitope is a composite epitope (pg. 24, column 6, lines 27-49, SEQ ID NO: 70, Pg. 29, column 15, lines 48-67 and column 16, lines 1-8). Fischer further teaches a composition comprising a peptide comprising the instant sequences of SEQ ID NO. 6, SEQ ID NO. 55, SEQ ID NO. 8, SEQ ID NO. 13, and SEQ ID NO. 61 (see claim 1 above) and immunogenic compositions comprising viral and/or bacterial nucleic acids that encode a peptide sequence of a pathogen, containing multiple epitopes, where at least one epitope is a composite epitope (pg. 24, column 6, lines 27-49, SEQ ID NO: 70, Pg. 29, column 15, lines 48-67 and column 16, lines 1-8).
Fischer does not teach that the composition comprises the nucleic acid sequence that encodes for a peptide comprising the instant sequences of SEQ ID NO. 6, SEQ ID NO. 55, SEQ ID NO. 8, SEQ ID NO. 13, and SEQ ID NO. 61. However, Presnell teaches reverse translation, wherein nucleic acid sequences can be determined from an amino acid sequence (Abstract).
It would have been prima facie obvious before to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Fischer for the peptide sequence with the teachings of Presnell for reverse translation. Presnell provides motivation by teaching that reverse translation facilitates the use of modular mutagenesis (Abstract). One of skill in the art would have had a reasonable expectation of success at combining Fischer and Presnell because they both teach peptide and nucleic acid sequences.
Fischer further teaches that almost any adjuvant can be used with the immunogenic composition comprising a composite epitope (Pg. 28, column 14, lines 36-50). Fischer does not teach that the adjuvant is a liposome adjuvant. However, Alving teaches that the Army Liposome Formulation (ALF) family, including ALFQ, are safe and potent vaccine adjuvants that produce both a Th1 and Th2 response (Abstract and Pg. 7 section 4). The ALFQ adjuvant is the only family member that produces a balanced Th1 and Th2 response (Pg. 7 section 4).
It would have been prima facie obvious before the effective filing date of the invention for one or ordinary skill in the art to have combined the teachings of Fischer for an immunogenic composition comprising composite epitope peptides and an adjuvant with the teachings of Alving for the adjuvant ALFQ. Alving provides motivation by teaching that ALFQ produces a balanced Th1 and Th2 response compared to other adjuvants (Pg. 7 section 4). One of skill in the art would have had reasonable expectation of success at combining Fischer and Alving because they both teach vaccines.
Regarding claim 23, Fischer teaches that the immunogenic composition induces an immune response in a mammal that is protective against infection by the one or more pathogens (pg. 24, column 6, lines 27-49).
Regarding claim 24, Fischer teaches that composition is protective against influenza virus (pg. 24, column 6, lines 27-49).
Regarding claims 25 and 27, Fischer teaches the reference peptide sequences SEQ ID NOs: 6 (HA), 8 (NA), 13 (M), and 54 (HA) which correspond to instant SEQ ID NOs: 6 (HA), 8 (NA), 13 (M), and 55 (HA). Fischer further teaches that these sequences can be coupled (as seen in reference SEQ ID NO: 66, coupling SEQ ID NOs: 6 (HA), 54 (NA), and 8 (HA)) to create a vaccine against multiple epitopes, allowing for a more broadly protective immune response. Fischer also teaches that adding a T-cell stimulating epitope allows for a T-cell response to the vaccine (Description of the Invention). Fischer further teaches reference SEQ ID NO: 60 which corresponds to instant SEQ ID NO: 61 and that this epitope can be coupled to influenza M protein epitopes (SEQ ID NO: 47). Fischer also teaches that the peptide sequence can have any combination of M1, M2, HA, NA, PB1, or PB2 proteins (pg. 24 column 6, lines 28-49) and multiple M peptide sequences (SEQ ID NOs: 22-48).
Regarding claim 28, Fischer teaches that the nucleic acid is DNA (pg. 24, column 6, lines 27-49, SEQ ID NO: 70, Pg. 29, column 15, lines 48-67 and column 16, lines 1-8).
Regarding claim 29, Fischer teaches that the nucleic acid is RNA (Pg. 29, column 15, lines 48-67 and column 16, lines 1-8).
Regarding claim 30, Fischer teaches that the immunogenic composition can be a DNA vaccine against a pathogen (Pg. 29, column 16, lines 20-36).
Regarding claim 34, the immunogenic composition of claim 22 was rendered prima facie obvious over Fischer, Presnell, and Alving as discussed above. The type of immune response induced by a certain immunogenic composition is an inherent property of that vaccine. Therefore, as the immunogenic composition was rendered obvious the types of antibodies induced are also obvious. The production of neutralizing antibodies are inherent to the peptide used, Fischer teaches that the peptides lead to the production of antibodies (pg. 30, column 18, lines 10-23). Therefore, these properties are inherent to the immunogenic composition and as the immunogenic composition has been rendered prima facie obvious, so too are the immune responses induced by the immunogenic composition.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Double Patenting
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claim 1-9 and 11-12 due to amendment to claim 1 and cancellation of claim 9). Claims 1-9 and 11-12 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 9-10, 14, 16-17, 19-21, 23, 25-28, 30-31, and 41 of U.S. Patent No. 11,866,463 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claim 22-24 and 28-30 due to amendment to claim 22). Claims 22-24 and 28-30 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 17, and 19 of U.S. Patent No. 11,866,463 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-3, 11-13, 22-24, 28, and 30 due to amendment to claims 1 and 22). Claims 1-3, 11-13, 22-24, 28, and 30 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7-9, 11-12, and 14 of U.S. Patent No. 10,004,799 (reference application/conflicting claims). Applicant’s amendment to claims 1 and 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claim 29 due to amendment to claim 22). Claim 29 was rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-11 of U.S. Patent No. 10,004,799 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-3, 9, and 11-12 due to amendment to claim 1 and cancellation of claim 9). Claims 1-3, 9, and 11-12 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 15, 25, and 27 of U.S. Patent No. 10,596,250 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-29 due to amendment to claim 22). Claims 22-24 and 28-29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 25, and 27 of U.S. Patent No. 10,596,250 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-4 and 8 due to amendment to claim 1). Claims 1-4 and 8 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-10 of U.S. Patent No. 9,598,462 (reference application/conflicting claims). Applicant’s amendment to claim 1 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-29 due to amendment to claim 22). Claims 22-24 and 28-29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 7-10 of U.S. Patent No. 9,598,462 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-2 and 6-11 due to amendment to claim 1 and cancellation of claim 9). Claims 1-2 and 6-11 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,485,166 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-30 due to amendment to claim 22). Claims 22-24 and 28-30 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-11, and 18 of U.S. Patent No.12,485,166 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-2 and 5-9 due to amendment to claim 1 and cancellation of claim 9). Claims 1-2 and 5-9 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-7, and 23-15 of U.S. Patent No. 12,331,083 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-30 due to amendment of claim 22). Claims 22-24, and 28-30 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-15 of U.S. Patent No.12,331,083 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-2, 5-6, 8-9, 22-24, and 29-29 due to amendment to claims 1 and 22 and cancellation of claim 9). Claims 1-2, 5-6, 8-9, 22-24, and 28-29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 17, 20, 24, and 28 of U.S. Patent No. 8,821,885 (reference application/conflicting claims). Applicant’s amendment to claims 1 and 22 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1, 6, 8-9, 22-24, and 28-29 due to amendment to claims 1 and 22 and cancellation of claim 9). Claims 1, 6, 8-9, 22-24, and 28-29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 14 17 of U.S. Patent No. 9,388,220 (reference application/conflicting claims). Applicant’s amendment to claims 1 and 22 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1, 5-6, 8-9, 22-24, and 28-29 due to amendment to claims 1 and 22 and cancellation of claim 9). Claims 1, 5-6, 8-9, 22-24, and 28-29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 10 of U.S. Patent No. 9,772,045 (reference application/conflicting claims). Applicant’s amendment to claims 1 and 22 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1, 6, and 9-10 due to amendment to claim 1 and cancellation of claim 9). Claims 1, 6, and 9-10 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-8, 12, and 14 of U.S. Patent No. 12,409,214 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-30 due to amendment to claim 22). Claims 22-24 and 28-30 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-15 of U.S. Patent No.12,409,214 (reference application/conflicting claims) in view of Presnell. Applicant’s amendment to claim 22 submitted15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-2, 4-5, and 9-10 due to amendment to claim 1 and cancellation of claim 9). Claims 1-2, 4-5, and 9-10 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 10-11, 22, 26-27, and 31-32 of copending Application No. 17/985,296 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-30 due to amendment to claim 22). Claims 22-24 and 28-30 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 13, 22, 26-27, and 33 of copending Application No. 17/985,296 (reference application/conflicting claims) and in view of Presnell. Applicant’s amendment to claim 22 submitted15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1-2, 6-14, 22-24, and 28-29 due to amendment to claims 1 and 22 and cancellation of claim 9). Claims 1-2, 6-14, 22-24, and 28-29 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 19-26, and 35-36 of copending Application No. 19/182,300 (reference application/conflicting claims). Applicant’s amendment to claims 1 and 22 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 1, 7, and 9 due to amendment to claim 1 and cancellation of claim 9). Claims 1, 7, and 9 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7-8, and 11 of copending Application No. 19/238,379 (reference application/conflicting claims). Applicant’s amendment to claim 1 and cancellation of claim 9 submitted 15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
(Previous rejection, withdrawn as to claims 22-24 and 28-29 due to amendment to claim 22). Claims 22-24 and 28-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 19/238,379 (reference application/conflicting claims) and in view of Presnell. Applicant’s amendment to claim 22 submitted15 May 2026 has overcome the rejection previously set forth in the Non-Final Office Action mailed 17 February 2026.
Response to Arguments
Applicant contends on page 22 of the Remarks submitted 15 May 2026 that the removal of “or fragments of derivative thereof” sufficiently traverses the 112(a) rejection.
In response: While the removal of “or fragments of derivative thereof” does partially traverse the 112(a) rejection, it still stands that all working examples within the Specification are made with a tetanus toxoid not the claimed diphtheria toxoid.
Applicant contends on pages 22-23 of the Remarks submitted 15 May 2026 that the combining of claims 1 and 31 and claims 22 and 32 traverses the 102 and 103 rejections.
In response: Applicant’s arguments with respect to the claims have been considered but 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.
Applicant contends of page 24 of the Remarks submitted 15 May 2026 that producing neutralizing antibodies by administering low doses of the composition in amended claim 1 when administered both intradermally and intramuscularly has not been shown in the art.
In response: MPEP §2112 states that “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” As stated above in the rejection of claims 33-34, the immunogenic composition is rendered prima facie obvious, so the properties of the composition are also obvious. One of skill in the art would not have had to have known that the property was inherent at the “relevant time”. Neutralizing antibodies are an expected immune response when the immune system has been introduced to a new peptide. Soley to rebut applicant argument, Li, et al. (Cell Death Differ. 2022 Jun;29(6):1107-1122.) evidences the natural immune response to a virus, including the production and affinity maturation of neutralizing antibodies (pg. 1113 column 1). The claims do not require the limitation of administering a “low dose” as stated in Applicants arguments. The instant claims are drawn to a composition not a method of administering and the amount of composition delivered is not a part of the instant claims.
Conclusion
NO CLAIMS ARE ALLOWED
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 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, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
Prosecution Insights