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. Formal Matters
A. In the response filed 7/1/26, Applicants elected Group II and traversed on the grounds that examination of all claims does not create an undue search burden. This argument has been considered, but is not deemed persuasive for the following reasons –
Group I - claims 1 and 3-7 lack novelty over each of (1) Rachubinski et al. and (2) Espinosa et al. (NCT04246372 – cited as reference 4 on the IDS filed 7/12/24). Rachubunski teaches the use of the JAK inhibitor tofacitinib for treatment of alopecia in DS patients. Espinosa teaches the use of tofacitinib for treatment of skin conditions in DS. Regarding claims 3-7, case law has established that a compound and all of its properties are inseparable, as are its processes and yields (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
Group I (claim 2) Hosseini et al. teaches baricitinib for the treatment of cancer (section 5.1; Table 1)
Group III – claim 16 lacks an inventive step over Hosseini et al. in view of any well-known chemotherapeutic treatment.
B. Claims 1-20 are pending. Claims 1-7 and 16-20 are withdrawn as being drawn to non-elected inventions. Claims 8-15 are the subject of this Office Action. For the above reasons, the restriction is deemed proper and is, therefore, made FINAL.
2. Specification
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.
3. Claim Objections
Claim 8 is objected to since it recites “administering an of a”.
4. Claim Rejections - 35 USC § 112(a) – scope of enablement
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 8-15 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for administration of baricitinib with a vaccine, does not reasonably provide enablement for improving vaccine effectiveness. 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.
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.
First, the specification and claims do not provide guidance with regard to improving the effectiveness of a vaccine using a JAK inhibitor. Furthermore, there are no working examples supporting an improvement. Though not directed to DS, Winthrop teaches that “[a]mong patients starting tofacitinib, diminished responsiveness to PPSV-23, but not influenza” was seen (Abstract). Winthrop further states “Collectively, these studies suggest that tofacitinib diminished responses to PPSV-23, particularly when used in combination with methotrexate, and that tofacitinib treatment has limited effect on influenza vaccine responses” (Discussion). This shows that it is unpredictable what vaccines may, or may not, be improved upon coadministration with a JAK inhibitor. While Applicants’ specification does provide guidance and working examples that the JAK inhibitor baricitinib does have effects in DS patients, it is not predictable that this, or any JAK inhibitor, would have the desired effect on vaccine efficacy, let alone a predictable effect on all vaccines.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed. Winthrop teaches Among patients starting tofacitinib, diminished responsiveness to PPSV-23, but not influenza
5. 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.
Claim 11 is 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. MPEP 608.01(m) states that “[e]ach claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).”
6. Conclusion
No claim is 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.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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