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 .
1. Election of Species
This application contains claims directed to the following patentably distinct species -
Claim 4 – one HCCR SEQ ID NO
The species are independent or distinct because each sequence requires its own potentially non-overlapping search. In addition, these species are not obvious variants of each other based on the current record. Therefore, there is a search and/or examination burden for the patentably distinct species as set forth above.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, all claims are generic.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
2. Election by Telephone
During a telephone conversation with Jennifer Livingston on 8/6/26 (initial voicemail left by the Examiner on 7/29/26) a provisional election was made to prosecute the species of SEQ ID NO:61. Affirmation of this election must be made by applicant in replying to this Office action.
3. Additional Information
Applicant is advised that the reply to this requirement to be complete must include an election of the invention to be examined even though the requirement be traversed (37 CFR 1.143).
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR § 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a diligently-filed petition under 37 CFR § 1.48(b) and by the fee required under 37 CFR § 1.17 (h).
4. Formal Matters
Claims 1-12 and 14-21 are pending and are the subject of this Office Action. Upon further review, all species have been examined.
5. Specification
A. If applicable, the first line of the specification should be updated to reflect the status (e.g. “now U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be found, any U.S. or Foreign Applications cited in the specification which have since issued should be updated with the corresponding Patent No.
B. The listing of references on pages 55-56 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
C. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
6. Claim Rejections - 35 USC § 112(a) – scope of enablement
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.
A. No rejection is being made over claim 11 with regard to the host cell not being isolated. Paragraph [0080] of the specification states that “[h]ost cells also include cells from multicellular organisms such as fungi, insect cells, plant cells or mammalian cells, preferably cells from mammals, such as Chinese hamster ovary (CHO) cells. Further examples of host cells include NS0…”
Though the definition does not rule out transfecting cells in a human (i.e. gene therapy), the specification does not disclose such a method. If such a definition is present in the specification, Applicant(s) may provide arguments as to its enablement, or the claim can be amended to recite, e.g., “An isolated host cell”.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
B. Claims 14, 16-18 and 20 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of vaccinating a subject against an intestinal infection, does not reasonably provide enablement for a method of vaccinating for any other diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The breadth of the claims is excessive with regard to claiming a method of vaccinating a subject against any disease. Applicants do not provide any guidance or working examples of such a vaccination, nor can the Examiner find any indication that vaccination other than for (1) infection (2) in the intestine is enabled in the prior or post-filing art. It appears that only infections, including those in claim 19, are enabled. Given this lack of guidance and working examples, it is not predictable to one of ordinary skill in the art how to vaccinate a subject for any condition other than an intestinal infection.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
7. Claim Rejections - 35 USC § 112(a) – written description
Claims 14, 16-18 and 20 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. As discussed in paragraph B above regarding enablement, the Examiner is unable to find any prior or post-filing art teaching the use of APN for vaccination of any condition other than intestinal infection. (see Van der Weken).
Therefore, other than vaccination. the specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous variant diseases. While it is possible that APN plays a role in other conditions, the specification and claims do not adequately describe any other members of the genus of diseases able to, in fact, be vaccinated against.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, intestinal infections (including those in claim 19), alone, are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
8. Conclusion
A. Claims 14, 16-18 and 20 are not allowable.
B. Claims 1-12, 15, 19 and 21 are allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is (571)272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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