Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amended claim set filed 18 Dec 2025 is acknowledged. Claims 1-2, 4-8, 10-15, and 53-56 are currently pending. Of those, claims 1, 4-5, 11, 13, 15, 53, 55 are currently amended, no claims are new, and no claims are withdrawn. Claims 3, 9, 16-51, and 57 are cancelled. Claims 1-2, 4-8, 10-15, and 53-56 will be examined on the merits herein.
Claim 5 has an unmarked amendment. The last claim set entered (30 Mar 2023) read “The method of any
Response to Arguments
The Applicants’ arguments filed 18 Dec 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 19 May 2025 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The objections to claims 4-5 and 53 (NFOA par. 25-26) are withdrawn in view of the claim amendments and arguments.
The rejection of claim 15 (NFOA par. 27-28) is withdrawn in view of the claim amendments and arguments.
The rejection of claims 1-2, 4-8, 10-15, and 53-56 under 35 U.S.C. 112(a) is withdrawn in part, see the maintained part of the rejection below. The declaration under 37 CFR 1.132 filed 18 Dec 2025 is sufficient to overcome the part of the rejection related to the outcome of altering the genome of the microbe (claim 12) because the declaration provides evidence that inactivation with 1500J or 2000J of UV and an unknown amount of riboflavin leads to an increase in the frequency of deletions compared to untreated M. tuberculosis (Goodrich declaration pg. 4 par. f). Also, the amendment to claim 13 renders moot the part of the rejection related to selectively oxidizing one or more guanine bases in a nucleic acid of the microbe.
The rejection of claims 1-2, 4, 6-8, and 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Watkins is withdrawn in view of the Goodrich declaration under 37 CFR 1.132 filed 18 Dec 2025. The statement that the thesis was not subject to a public defense and was embargoed before being made publicly available on 8 Jan 2022 as indicated on the Colorado State University website (Goodrich pg. 3 par. 3) overcomes the rejection because 8 Jan 2022 is after the effective filing date (2 Oct 2020).
The rejection of claims 1-2, 4, 6-8, and 10-11 under 35 U.S.C. 103 as being unpatentable over Marschner et al. in view of World Health Organization (WHO) and Ioerger et al., and as evidenced by Asif et al. and Watkins is withdrawn in view of the claim amendment requiring that the inactivated Mycobacterium be suitable for use in a vaccine. Claim 53, which also recited this limitation, was not previously rejected.
The double patenting rejections related to U.S. Patent No. 6,843,961 and 8,017,110 are withdrawn in view of the claim amendment requiring that the inactivated Mycobacterium be suitable for use in a vaccine. Claim 53, which also recited this limitation, was not previously rejected.
Drawings/Specification
The drawings and specification are objected to under 37 CFR 1.83(a) because Figures 8E-F fails to show Vaccine Groups 5 and 6 as described in the specification (see par. [0161] and Table 2 pg. 39-40 of the amended specification filed 18 Dec 2025). Figure 8 describes the two irradiated Mycobacterium tuberculosis H37Rv vaccines as both using 106 bacteria. However, Figures 4-7 and the specification as amended describe two different irradiated M. tuberculosis vaccines having 105 or 106 bacteria.
Any amendments to the drawings and specification must not introduce new matter and should point out support in the application as filed. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: Inactivated Mycobacteria vaccines, and methods for use and production thereof.
Claim Objections
Claim 15 is objected to because of the following informalities: improper verb tense. The claim reads “the method does not comprise alter the structure of antigens”, but should read either “comprise altering” or “alter”. Appropriate correction is required.
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The Mycobacterium tuberculosis complex (MTBC) includes “M. africanum (i.e., MTBC lineage 5 and lineage 6) (2), M. bovis (3), M. canettii (4), M. caprae (5), M. microti (6), M. mungi (7), M. orygis (8), M. pinnipedii (9), M. suricattae (10), and M. tuberculosis (i.e., MTBC lineage 1 to lineage 4, lineage 7, and lineage 8) (11–13)” (Bespiatykh et al.; 21 Jul 2021; PTO-892; par. bridging pg. 1-2). Although Bespiatykh et al. is not prior art, references 2-12 are all prior art references; therefore the Bespiatykh reference indicates the state of the art at the time of filing. MPEP 2124 states that a non-prior art reference can be used to provide evidence on whether or not a claim is indefinite (in this case, whether the claim term “Mycobacterium tuberculosis complex” has a well-known, art-recognized definition) based on the knowledge as of the application’s filing date. This term refers to the same collection of bacterial species as is listed in claim 5.
Claim Interpretation
Regarding claims 10-11 and 54-55, the specification specifically defines the term “about” as encompassing variations +/- 20% [0032]. Therefore, the range searched for “about 100 Joules to about 25,000 Joules” is 80-30,000 Joules, and the range searched for “about 2,000 Joules” is 1,600-2,400 Joules.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(a)
Claims 1-2, 4-8, 10-15, and 53-56 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method that achieves the outcome of inactivating a microbe, does not reasonably provide enablement for a method that achieves the outcome of producing a microbial vaccine or a vaccine that does not alter the structure of antigens on the surface of the microbe so as to impede their immunogenicity compared to microbe that has not been inactivated. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The rejection has been modified to reflect the claim amendments, a response to the arguments follows the updated rejection.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims: Claim 1, and its dependent claims 2, 4-8, and 10-14, have been amended to recite methods of inactivating a Mycobacterium microbe comprising isolating the microbe in a pharmaceutically acceptable ingredient, and contacting it with UV light in the presence of riboflavin. The claim has also been amended so that the resulting inactivated Mycobacterium must be suitable for use in a vaccine. Claim 15 further requires the function that “the method does not comprise alter the structure of antigens on the surface of the microbe so as to impede their immunogenicity compared to microbe that has not been inactivated.” Claims 53-56 are methods for producing a microbial vaccine comprising steps of providing a plurality of M. tuberculosis microbes, inactivating the microbes by contacting them with UV light in the presence of riboflavin, and optionally purifying the inactivated microbes (required by claim 56 only).
The instant specification defines the term “vaccine” as “a composition, which is used to induce an immune response against the microbe that provides protective immunity (e.g., immunity that protects a subject against infection with the pathogen and/or reduces the severity of the disease or condition caused by infection with the pathogen)” [0046]. Therefore, the outcome of these methods must be a composition that provides protective immunity against M. tuberculosis.
The existence of working examples: The specification reduces to practice two different compositions comprising UV-and-riboflavin-inactivated M. tuberculosis; vaccination groups 3 and 4 in Example 3 (see par. [161] and Table 2 on pg. 39-40). These bacteria in these compositions are inactivated, as shown in Figures 1-3. Mice were administered the experimental vaccines, challenged via aerosol infection with virulent M. tuberculosis [0162], and researchers measured bacterial growth in the lungs as well as spread to the spleen. Figure 4 and Table 3 (pg. 40) both show that the two UV-and-riboflavin-inactivated M. tuberculosis compositions do not significantly reduce bacterial growth compared to the saline control. However, the non-inactivated BCG vaccine (“Group 2”) significantly protected against bacterial growth in the lung [Figure 4A, Table 2]. The live BCG vaccine also produced a different cytokine response compared to the inactivated “17280J MTB H37Rv” vaccine for almost all cytokines measured [Figure 6].
Therefore, the UV-and-riboflavin-inactivated compositions cannot be considered “vaccines” because they do not have a protective effect as required by the specification’s definition. The data also suggests that the antigenic structures on these bacteria were altered so as to impede their immunogenicity compared to the BCG microbe that has not been inactivated due to the lack of immunity against live M. tuberculosis and the difference in cytokine response.
Other teachings in the specification and prior art: The other teachings of the specification and the art do not provide evidence that a M. tuberculosis inactivated using UV and riboflavin can be used as a vaccine to induce protective immunity; therefore, these other teachings do not outweigh the specific evidence in the specification that such a composition cannot be used as a vaccine.
The level of predictability in the art and the quantity of experimentation needed to make or use the invention: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success and without undue experimentation. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution.
Given that the nature of the invention is making a vaccine with in vivo property of inducing protective immunity, the level of predictability is low and the quantity of experimentation is high. The specification teaches a composition that cannot perform the in vivo function, and does not provide the required guidance to identify compositions made by the claimed method that do have the required properties. To demonstrate the method could be used with a reasonable expectation of success, a person having ordinary skill in the art at the time of filing would have to perform significant further in vivo experimentation, similar to the ones of Example 3 to determine whether it is possible to use M. tuberculosis inactivated with UV and riboflavin as a vaccine, and if so, what parameters need to be changed relative to the ineffective vaccine in Example 3, with no guidance from the specification or the art at the time of filing.
Also, to determine whether or not the antigenic structures on the surface of the microbe were altered so as to impede their immunogenicity compared to microbe that has not been inactivated, one of ordinary skill in the art would need to test the putative vaccines’ immunogenicity in a variety of methods against a variety of different live Mycobacterium strains in order to determine whether the any aspects of the immune response have been altered. The level of predictability is low and the quantity of experimentation is high given the specification’s only example had an altered immune response as compared to a live vaccine and there is no guidance in the specification or art for choosing an improved method compared to the unsuccessful example.
In both situations, the amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of altering the genome, oxidizing guanine bases, or successfully producing a vaccine. Therefore, claims 5, 12-15 and 53-56 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
Response to Arguments
Applicant argues (Remarks pg. 8) that Watkins cannot be considered prior art as supported by the Goodrich Declaration.
Applicant further argues (Remarks pg. 8-9) that a person of ordinary skill would understand photochemical inactivation would oxidize guanine residues in the genome, as evidenced by cited references.
This argument has been carefully considered and has been rendered moot by the claim amendments. The parts of the rejection related to guanine modification, including the citation of Watkins to show the genome of the Mycobacterium is not altered by shearing or 8-oxoguanosine formation, have been withdrawn for the reasons discussed above and have been removed from the rejection.
Applicant argues (Remarks pg. 8) that the specification and figures demonstrate inactivation of a Mycobacterium.
The examiner agrees with this argument, note that NFOA par. 29 stated the claims “[are] enabling for a method that achieves the outcome of inactivating a microbe”.
Applicant argues (Remarks pg. 8) that “An immune response was demonstrated in vivo, as well as a reduction in the spread of the infection to the spleen. Further, a lower concentration of IL-10 was detected in infected mice indicating the activation of Th1 immunity in response to the inactivated Mtb. (See e.g., Examples 3-4, FIG. 4-8.)”
This argument has been carefully considered but is not found persuasive. The instant specification defines the term “vaccine” as “a composition, which is used to induce an immune response against the microbe that provides protective immunity (e.g., immunity that protects a subject against infection with the pathogen and/or reduces the severity of the disease or condition caused by infection with the pathogen)” [0046] (cited in NFOA par. 32 and above par. 20). Data about IL-10 levels are not relevant to showing that the composition protects a subject against infection with the pathogen and/or reduces the severity of the disease or condition caused by infection with the pathogen.
The data from the specification does not show a reduction in spread of infection to the spleen. The analysis in Table 3 showed that the p-value for group 3 was 0.9994, indicating that the variation observed cannot be differentiated from chance variation, and that group 4 showed an increase in bacterial counts in the spleen, that is also not statistically significant. Figure 4B shows that the irradiated M. tuberculosis mouse groups are not significantly different from the control saline-treated mice (note the lack of stars as described in the figure legend at [0020], and shows that the mice receiving UV/riboflavin irradiated bacteria (“17280J MTB H37Rv”) had highly variable levels of bacterial spread to the spleen. The bacterial spread to the spleen may have been slightly lower, slightly higher, or similar to the mice receiving the saline control. This data was discussed in the NFOA par. 33 and above par. 21.
Applicant argues (Remarks pg. 8) that the ‘640 declaration is supported and enabled by experimental data from the Goodrich declaration.
Goodrich declaration argues:
A UV dosage of 2000 J in the presence of riboflavin inactivates M. tuberculosis (pg. 1 par. a).
SolaVAX-TB is M. tuberculosis treated with riboflavin and UV (dosages not disclosed), this treatment induced a strong immune response associated with increased immune protection, including: 1) increased CD4+ T-cell activation; 2) increased expression or terminal differentiation and exhaustion markers of CD8 as well as CD8+ CD44+ T cells; and 3) B1-B cels activation by T-dependent mechanism. (pg. 2-3 par. b).
SolaVAX-TB treatment reduced in reduced bacterial burden in mice 90-days post-infection (pg. 3 par. c).
M. tuberculosis H37Rv can be inactivated by 1500 J or 2000 J of UV light in the presence of riboflavin (pg. 3-4 par. d-e).
The M. tuberculosis genome has an increase in deletion frequency after treatment by 1500J or 2000J of UV light in the presence of riboflavin (pg. 4 par. f).
SolaVAX-TB treatment produces comparable levels of CDB+ CD8+ IFNY+ CD44+, CD3+ CD4+, and CD3+ CD4+ IFNy+ CD44+ splenocyte cells that react to M. tuberculosis lysate, compared to vaccination with BCG, Goodrich argues this shows immunogenicity of SolaVAX-TB (pg. 4-5 par. g-h).
BCG vaccination boosted with SolaVAX-TB improves protection against M. tuberculosis infection (pg. 5 par. i).
Pg. 5-6 par. j describes an experiment in which “female C57B1/6 mice were vaccinated with Saline or BCG and boosted with BCG or SolaVAX-TB (intranasally or intramuscularly) alongside Inulin and CpG1018 adjuvants respectively. As shown below, mice were infected with frozen HN878 via aerosol chamber and sacrificed 30 and 90 days post infection and inferior lung lobes sampled and processed for H&E staining.” The results of the experiment are not described and the image of data is not clear. However, it appears that panel A shows that there is a lower lesion burden at 90 days for all experimental groups compared to saline treatment. There is no difference at 30 days.
SolaVAX-TB increases CD44+ dendritic cells (pg. 6 par. k-l).
“SolaVAX-TB double boost resulted in reduced bacterial burden in infected mice. As shown below, female C57BI/6 mice were vaccinated with Saline or BCG and boosted with BCG or 2x with SolaVAX-TB.” (pg. 6-7 par. m).
SCID mice vaccinated with SolaVAX-TB survive longer than mice vaccinated with BCG. Goodrich argues the vaccine is safer than BCG because it contains inactivated particles and no viable bacteria that can induce adverse effects (pg. 7 par. n).
“The above data demonstrates that UV/riboflavin inactivated Mtb showed similar immunogenicity profiles as BCG vaccinated mice. This confirms the claims of the '640 Application which shows that the inactivated Mtb at least generates comparable immune response as BCG as a single vaccine dose and that UV/riboflavin mediated inactivation is coupled with the preservation of the Mtb's antigenicity. Importantly, because BCG is a "live attenuated vaccine" and the inactivated Mtb vaccine is generating a similar response, confirms the antigens are still "intact" further supporting claims of the '640 Application.” (pg. 7 par. 5).
This argument has been carefully considered but is not found persuasive. In response to Goodrich (a) and (d), the ability of the treatment to inactivate M. tuberculosis is not contested, note that NFOA par. 29 stated the claims “[are] enabling for a method that achieves the outcome of inactivating a microbe”. In response to Goodrich (e), this argument is persuasive and the part of the rejection about genome modifications has been withdrawn.
In response to arguments about SolaVAX-TB (Goodrich (b)-(c) and (f)-(k)), the examiner agrees that the data shows that the SolaVAX-TB formulation is an effective vaccine. However, these arguments rely on one formulation, which was treated with an undisclosed UV treatment and an undisclosed riboflavin concentration. The one successful formulation does not change the examiner’s opinion that the level of predictability for achieving a composition that can be used as a protective vaccine is low when considered across the full claim scope of all possible “contacting” steps. The existence of the successful SolaVAX-TB formulation is not prior art and therefore would not have been available as guidance to one of ordinary skill at the time of filing who is trying to make or use the claimed invention. The declaration also does not provide any evidence about how likely an arbitrarily chosen inactivation method within the scope of claim 1 is to be successful or how much experimentation was required to result in the successful SolaVAX-TB formulation when beginning with the unsuccessful formulation disclosed in the specification. Therefore, the examiner remains of the opinion that: “Given that the nature of the invention is making a vaccine with in vivo property of inducing protective immunity, the level of predictability is low and the quantity of experimentation is high. … To demonstrate the method could be used with a reasonable expectation of success, a person having ordinary skill in the art at the time of filing would have to perform significant further in vivo experimentation, similar to the ones of Example 3 to determine whether it is possible to use M. tuberculosis inactivated with UV and riboflavin as a vaccine, and if so, what parameters need to be changed relative to the ineffective vaccine in Example 3, with no guidance from the specification or the art at the time of filing.”
Therefore, the rejection is maintained for the reasons of record and the reasons herein.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-15 are newly 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.
Regarding claim 13, the claim has been amended to recite “the pharmaceutically acceptable ingredient is selected from … a sweetening agents.” The sweetening agents is plural, which differs from the use of singular nouns for “pharmaceutically acceptable ingredient” and the other objects listed. The claim is indefinite because it is unclear whether the claim requires that multiple sweetening agents be chosen together as a pharmaceutically acceptable ingredient, or whether the claim contains a grammatical error and should read “sweetening agent” to be consistent with the other ingredients listed. Claims 14-15 are also rejected because they depend from claim 13 and do not obviate this grounds of rejection.
Regarding claim 14, the claim recites “The method of claim 13, wherein the nucleic acid of the microbe is a DNA or an RNA.” There is insufficient antecedent basis for the term “the nucleic acid of the microbe” because claim 13 has been amended to remove the antecedent basis for the term.
Regarding claim 15, the term “impede … immunogenicity compared to microbe that has not been inactivated” in claim 15 is a relative term which renders the claim indefinite. The terms “impede” and “immunogenicity” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Impeding” recites a value judgement, where one of ordinary skill may or may not have the opinion that a value has been modified enough to be impeded (as contrasted with an objective, measurable change such as an increase or decrease). Also, “immunogenicity” is a vague term because it could be measured many different ways (for example, stimulating various cytokines in non-immune cells, stimulating various responses in different types of immune cells, the presence or absence of various antigens, etc.). Finally, the comparison to a generic “microbe that has not been inactivated” cannot be used as a defined comparison because different live strains have different immunogenic properties (Aguirre-Blanco et al. 2007; PTO-892; Abstract). Therefore, the claim is indefinite because one of ordinary skill in the art could not objectively determine what the “immunogenicity” is and whether it has been “impeded” relative to a generic, undefined “microbe that has not been inactivated”.
Claim Rejections - 35 USC § 112(a)
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.
Claim 15 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.
Regarding claim 15, the claim has been amended to recite “the method does not comprise alter the structure of antigens on the surface of the microbe so as to impede their immunogenicity compared to microbe that has not been inactivated.” Applicant has not pointed out where the amended claim is supported, but has only stated “claim 15 has been amended to clarify that method described in independent claim 1 does not alter the structure of antigens on the surface of the microbe so as to impede their immunogenicity compared to a microbe that has not been inactivated.” (Remarks pg. 8). There does not appear to be a written description of the claim limitation “alter[ations that] … impede their immunogenicity compared to microbe that has not been inactivated” in the application as filed. The only reference to “immunogenicity” in the specification as filed is in [0005], which states “Exposure to harsh chemical and/or physical agents may also destroy the antigenic profile of the microbes, thus reducing or even destroying immunogenicity”, but this does not adequately describe method steps would or would not impede immunogenicity because it states that even harsh chemical and/or physical agents only has the possibility of maybe reducing or destroying immunogenicity, it doesn’t include or exclude any specific methods. Accordingly, the newly amended claim limitations constitute new matter.
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 AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645