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 .
DETAILED ACTION
1. Claims 1-19 are being considered.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 10/7/20. It is noted, however, that applicant has not filed a certified translation of the JP2020-169704 application as required by 37 CFR 1.55. Thus, the instant application will be examined with an effective filing date of the 371 application filing date (10/7/21).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
3. The information disclosure statements (IDS) were submitted on 06 April 2023 and 18 December 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Specification
4. The abstract of the disclosure is objected to because the phrase “assisting a determination” is unclear. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
5. The use of the term ‘MagnICON’ in ¶ [0039], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that ‘MagnICON’ is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
6. Claim 1 is objected to because of the following informalities: the phrase ‘post-infection’ is repeated. Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-8 and 14-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 14 recite “A method of assisting a determination”. It is unclear if ‘assisting’ is a supplemental step or the only step to making the determination, as claimed.
Claims 2-7 and 15-19, which are dependent on claims 1 and 14, respectively, are similarly rejected.
The term ‘relatively’ in claim 2 is a relative term which renders the claim indefinite. The term ‘relatively’ is 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.
Claims 1 and 3-4 recite “susceptible to infection by norovirus or whether a subject is susceptible to or post-infection worsening by norovirus”, which is unclear. A suggested rewording would be: “susceptible to infection or post-infection worsening by norovirus.”
Claim 2 is rejected for similar unclear wording.
Claim 4 recites “…and in cases other than this…” it is unclear what ‘this’ is referring to.
In claim 8, the relationship between the administration of the vaccine and the step of measuring is unclear.
Claim 16 recites the limitation "present in samples". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites an assessment of IgG antibody concentrations before and after administration of a norovirus vaccine. This is unclear because claim 14, on which it depends, does not appear to recite or require a vaccination step.
9. 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.
10. Claims 8-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
When establishing a 35 U.S.C. 112(a) written description rejection, the burden is on the Examiner to set forth a prima facie case providing reasons why the specification is deficient and thus the claims that relies thereon are rejected. It is important to note that each claim is given its broadest reasonable interpretation in light of and consistent with the written description (see MPEP 2111 and 2163(II)). Additionally, a full review of the application must be done to understand how the applicant provides support for the claimed invention during each element and/or step, which includes the specification, drawings, structural chemical formulas, etc. (see MPEP 2163(II)). Finally, a determination as to whether the applicant was in possession of the claimed invention at the time of filing is made by considering (see MPEP 2163(II)):
The variety of ways that that applicant may show possession,
The level of skill and knowledge in the art, and
The predictability in the art.
Each of the claims are drawn, either inherently or explicitly, to the possession of a norovirus vaccine or would require a norovirus vaccine in order to perform the method as described. The specification does not provide a method of making a norovirus vaccine, nor a way to source a norovirus vaccine from a third-party. Additionally, the supplemental information (e.g., the drawings), only provides IgA and IgG concentration information, wherein the samples were collected from subjects at two different time points. There was no indication that the subjects were administered a norovirus vaccine at any point during this study.
At the time of filing, there was no norovirus vaccine available for preventing infection, as evidenced by the specification of the instant application: “There are no drugs that are effective against norovirus infection and onset, and only symptomatic treatment, such as rehydration, is available. In addition, a norovirus vaccine, e.g., for preventing infection, has yet to be developed.” (see Specification, ¶ [0003]). This is further supported by Tamminen (Clin. Immunol., 2018, 197, 110-117) (See IDS filed on 6 April 2023), “NoV outbreaks and wintertime sporadic infections cause morbidity and mortality particularly in vulnerable populations, and put a huge burden on healthcare, as no preventative vaccine is available.” (Section 1. Introduction, ¶ 1). Thus, a fully functional and publicly available norovirus vaccine would not be predictable in the art, and it cannot be assumed that it would be well-known or conventional in the art, therefore requiring a disclosure in detail.
In view of the fact that the examples provided do not demonstrate possession of a norovirus vaccine, the application has not identified a norovirus vaccine, and one of ordinary skill in the art at the time of filing would not have recognized the possession of a norovirus vaccine, there is insufficient written description support for a norovirus vaccine.
11. Claims 8-18 are 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 norovirus vaccine development and procedural testing, does not reasonably provide enablement for a fully-functional norovirus vaccine. 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.
In making a determination as to whether an application has met the requirements for
enablement under 35 U.S.C. 112 ¶ 1, the courts have put forth a series of factors. See, In re
Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantity
of experimentation necessary, (2) the amount of direction or guidance presented, (3) the existence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6)
the level of ordinary skill in the art, (7) the level of predictability in the art, and (8) the
breadth of the claims. While it is not essential that every factor be examined in detail, those
factors deemed most relevant should be considered. In the present case, the factors deemed
relevant are those of: the breadth of the claims, the state of the prior art, the amount of direction and the working examples provided, and the quantity of experimentation necessary.
Regarding the breadth of the claims, each of the claims are drawn to a method that would require a norovirus vaccine in order to make an assessment or determination, which is not enabled. However, the actual step of assessing antibody concentrations in norovirus vaccine development and testing is enabled.
Regarding the state of the prior art, the instant application states: “There are no drugs that are effective against norovirus infection and onset, and only symptomatic treatment, such as rehydration, is available. In addition, a norovirus vaccine, e.g., for preventing infection, has yet to be developed.” (see Specification, ¶ [0003]). This is further supported by Tamminen (Clin. Immunol., 2018, 197, 110-117) (See IDS filed on 6 April 2023), “NoV outbreaks and wintertime sporadic infections cause morbidity and mortality particularly in vulnerable populations, and put a huge burden on healthcare, as no preventative vaccine is available.” (Section 1. Introduction, ¶ 1) and Malm (JID, December 2014, 220(11), 1755-1762) (See PTO-892: Notice of References Cited), “Consequently, research and development efforts are underway to create a vaccine that can protect against NoV infection.” (¶ 1). However, Tamminen does teach “that naïve individuals such as children might require mucosal administration of NoV VLP vaccine in order to generate neutralizing IgA on mucosal surfaces. The results of this study encourage further investigating NoV-specific mucosal immune responses, especially in vaccine design.” (Section 4. Discussion, last ¶). Thus, at the time of filing, there were methods for norovirus vaccine development and testing, but there was no publicly or fully functional vaccine available in the prior art.
Regarding the amount of direction and working examples provided, the present specification discloses comparing anti-norovirus IgG and IgA antibody concentrations at two different time points in order to determine suitability for a norovirus vaccine, timing of norovirus vaccination administration, or norovirus vaccine efficacy. The working examples address the methods of sample collection, processing,
Regarding the quantity of experimentation necessary, the skilled artisan would be required to conduct an undue amount of experimentation in order to develop a fully functional norovirus vaccine that is suitable to administer to humans.
As discussed above, undue experimentation would be required to practice the claimed invention commensurate with the scope of the claims. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the breadth of the claims, the state of the prior art, the lack of sufficient guidance and limited working examples in the specification, and the quantity of experimentation necessary, it would take undue trials and errors to practice the claimed invention.
Claim Rejections - 35 USC § 101
12. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
13. Claims 2-4, 9-10, and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite “a step of assessing”. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP 2106 for analysis framework.
The instant claims are drawn to a method with steps assessing subject susceptibility/resistance to norovirus, subject eligibility for a norovirus vaccine, or the efficacy of a norovirus vaccine. As such, the instant claims are drawn to a process, which is statutory category of matter (Step 1: Yes).
The instant claims are drawn to a judicial exception of an abstract idea, more specifically a mental process. The step of assessing could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception, which may be termed as an abstract idea (Step 2A, Prong 1: Yes). The instant claims are drawn solely to a judicial exception which is not integrated into a practical application because the claimed invention is not used to provide a particular treatment or prophylaxis for a disease or medical condition. Further, the claimed invention does not apply or use the judicial exception in a meaningful way and there is no inventive concept in the claims. Generally linking the use of the judicial exception to a particular technological environment or field of use, such as norovirus susceptibility, is not indicative of integration into a practical application (see MPEP 2106.05(h) and Example 29, Claim 2 (Diagnosing and Treating Julitis) of the Subject Matter Eligibility Examples: Life Sciences found at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf)). Therefore, the instant claims do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prong 2: No).
The instant claims are drawn to a judicial exception and do not recite any additional elements that amount to significantly more than the judicial exception (Step 2B: No).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
14. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
15. Claims 1 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tamminen (Clin. Immunol., 2018, 197, 110-117) (See IDS filed on 6 April 2023).
Regarding claims 1 and 7, Tamminen teaches “We showed that salivary anti-NoV IgG and IgA levels correlate significantly with serum IgG and IgA levels […] The levels of IgG and IgA in saliva significantly correlated with each other, indicating that measuring either isotype gives sufficient information on pre-existing immunity.” (Section 4. Discussion, ¶ 2).
Regarding claims 5-6, Tamminen teaches “The highest antibody levels in both serum and saliva were detected against GII.4 99 VLPs.” (Section 4. Discussion, ¶ 5).
Claim Rejections - 35 USC § 102/103
16. 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.
17. Claim 8, 11-14, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tamminen (Clin. Immunol., 2018, 197, 110-117) (See IDS filed on 6 April 2023).
Regarding claims 8, 13-14, and 19, Tamminen teaches that “We hypothesize that secretory blocking IgA might have a role in the first line defense against NoV prior passing the mucosal layer, but once the virus penetrates this mucosal barrier, the high level of systemic blocking IgG is most likely imperative in controlling the infection. […] that naïve individuals such as children might require mucosal administration of NoV VLP vaccine in order to generate neutralizing IgA on mucosal surfaces. The results of this study encourage further investigating NoV-specific mucosal immune responses, especially in vaccine design.” (Section 4. Discussion, last ¶). Tamminen also teaches that IgA and IgG levels are correlated (see section 15 above). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use both IgA and IgG levels as an indicator of both vaccine efficacy and whether a vaccine should be administered or not. A rationale to support a conclusion that a claim would have been obvious is that there is some teaching, suggestion, or motivation in the prior art or in the knowledge generally available to one of ordinary skill in the art to modify the reference or combine reference teachings, and the modification or combination would have a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, G. and 2143.02).
Regarding claims 11-12 and 17-18, they are similarly rejected for being dependent on claims 8 and 14, respectively (see above paragraph). In addition, Tamminen teaches that antibodies were specific for the norovirus GII.4 strain (see section 15 above).
Claim Rejections - 35 USC § 103
18. 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.
19. Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tamminen as applied to claims 1 and 5-7 in section 15 (Clin. Immunol., 2018, 197, 110-117) (See IDS filed on 6 April 2023) and further in view of Malm (JID, December 2014, 220(11), 1755-1762) (See PTO-892: Notice of References Cited).
20. Regarding claims 2-3, Tamminen teaches the method of assessing a subject’s susceptibility to norovirus by measuring anti-norovirus IgG antibodies of claim 1, as seen above in section 15. Tamminen does not teach the specific concentrations at which such determinations are made. However, Malm teaches “The main objective of the present study was to assess correlation of preexisting serum IgG levels and/or antibody-blocking potential and susceptibility to infection with the predominant GII-4 NO genotype. Significant difference in preexisting GII-4 NO–specific antibody responses was observed when IgG titers of the patients who acquired GII-4 NO infection were compared to IgG titers of patients who acquired other GII genotype infection. Of 16 patients without GII-4 NO infection, 9 had very high preexisting GII-4 NO IgG levels (end point titer, >51 200; GMT, 94 809), whereas all 27 GII-4 NO–infected patients had acute serum GII-4 NO–specific end point titers of <50 000 (GMT, 958).” (Discussion, ¶ 2).
Therefore, it would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to measure the anti-norovirus IgG antibodies as in Tamminen and further include specific cutoff values for determining norovirus infection susceptibility as in Malm. It would further be obvious with that the IgG antibody concentrations are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (In re Aller, 220 F.2d 454, 456, 105 USPQ 2).
21. Regarding claim 4, Tamminen teaches the method of assessing a subject’s susceptibility to norovirus by measuring anti-norovirus IgG antibodies of claim 1, as seen above in section 15. Tamminen does not teach the specific concentrations at which such determinations are made. However, Malm teaches “Taken together, our results show a correlation between a low acute-phase serum GII-4 NO–specific IgG titer (end point titer, ≤12 800) and a low antibody-blocking potential (BT90, ≤100) with a high susceptibility to GII-4 NO infection. Congruently, a high specific IgG end point titer and a considerable blocking potential appeared to protect from GII-4 NO infection.” (Discussion, ¶ 4).
Therefore, it would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to measure the anti-norovirus IgG antibodies as in Tamminen and further include specific cutoff values for determining norovirus infection susceptibility as in Malm. It would further be obvious with that the IgG antibody concentrations are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (In re Aller, 220 F.2d 454, 456, 105 USPQ 2).
22. Claims 9-10, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tamminen as applied to claims 8, 11-14, and 17-19 in section 17 (Clin. Immunol., 2018, 197, 110-117) (See IDS filed on 6 April 2023) and further in view of Malm (JID, December 2014, 220(11), 1755-1762) (See PTO-892: Notice of References Cited).
23. Regarding claims 9-10 and 15-16, Tamminen teaches that the IgG and IgA antibody levels can be used in both vaccine design and determination if a child may need a vaccine, as in claims 8 and 14, respectively (see section 17 above). Tamminen does not teach the specific concentrations at which such determinations are made. However, Malm teaches IgG concentrations in which are correlated to norovirus susceptibility, as seen above in sections 19 and 21, respectively.
Therefore, it would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to measure the anti-norovirus IgG antibodies as in Tamminen and further include specific cutoff values for determining norovirus infection susceptibility as in Malm (see section 20 above). It would further be obvious with that the IgG antibody concentrations are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (In re Aller, 220 F.2d 454, 456, 105 USPQ 2).
Conclusion
24. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672