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 .
Amendment Entered
In response to the amendment filed on June 8th, 2026, amended claims 1 and 8-9, and new claims 10-11 are entered. Claim 7 is canceled. Claims 1-5 and 8-11 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 103 have been fully considered. The rejections are withdrawn in view of the amendment.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “40a” and “40b” have been used to refer to both “recesses” and “wells”, as seen in Figure 4.
The Applicant’s Specification recites “[r]eferring now to FIGURE 4…recesses 40a and 40b” in [0067]. Figure 2 shows “40a” as a “recess”; Figure 4 shows “40a” and “40b” as “recesses”; Figure 6 shows “40a” as a “recess”; Figure 10 shows “40a” and “40b” as “recesses”; and Figure 12 shows “40a” as a “recess”. However, the Applicant’s Specification also recites “[w]ith further reference to FIGURE 4…each well section (e.g., 406) includes a set of wells (e.g., 40a, 40b, 40c, 40d, 40e, etc.)” in [0068] and “[r]eferring now to FIGURE 7…each well (e.g., 40a, 40b, 40c, etc.)” in [0069]. Figure 1 shows “40a” and “40b” as “wells”; Figure 4 shows “40a” and “40b” as “wells”; Figure 7 shows “40a” and “40b” as “wells”; and Figure 9 shows “40a” as a “well”.
It appears that the “recesses” should be indicated by reference characters “41a” and “41b” instead of “40a” and “40b”, as the Applicant’s Specification recites “recess 41a” in [0066], “the recesses 41a and 41b” in [0070], and “recesses 41a, 41b (best seen in FIGURE 8)” in [0078].
Therefore, as best understood by the Examiner, Figures 2, 4, 6, 10, and 12 are objected to because of the following informalities:
Figure 2 indicates an element as “40a”, but should read “41a”
Figure 4 indicates two separate elements as “40a”. The indicator “40a” shown on the right side of Figure 4 (located below the “11a” indicator and above the “402” indicator), should be changed to read “41a”
Figure 4 indicates two separate elements as “40b”. The indicator “40b” shown on the left side of Figure 4 (located below the “11b” indicator and above the “404” indicator), should be changed to read “41b”
Figure 6 indicates an element as “40a”, but should read “41a”
Figure 10 indicates an element as “40a”, but should read “41a”
Figure 10 indicates an element as “40b”, but should read “41b”
Figure 12 indicates an element as “40a”, but should read “41a”
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. 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
In view of the objections to the drawings above, the disclosure is objected to because of the following informalities:
[0063] of the Applicant’s Specification recites “tabs 11a interlocking with recesses 40a provided in pairs (only one visible)”, but should read “tabs 11a and 11b interlocking with recesses 41a and 41b (only tab 11a and recess 41a visible in Figure 1)”
[0067] of the Applicant’s Specification recites “recesses 40a and 40b”, but should read “recesses 41a and 41b”
Appropriate correction is required.
Claim Objections
Claims 1 and 8-10 are objected to because of the following informalities:
Claim 1 recites “the well sections including a plurality of wells corresponding to the plurality of head elements” in lines 6-7, but should read “each well section including a plurality of wells, wherein each well corresponds to a head element of the plurality of head elements”
Claim 8 recites “the well sections including a plurality of wells corresponding to the plurality of head elements” in line 7, but should read “each well section including a plurality of wells, wherein each well corresponds to a head element of the plurality of head elements”
Claim 9 recites “at least one of the plurality of head elements” in line 4, but should read “at least one head element of the plurality of head elements”
Claim 9 recites “shorter than each of the plurality of piercing tips” in lines 13-14, but should read “shorter than each of the piercing tips”
Claim 9 recites “the well sections including a plurality of wells corresponding to the plurality of head elements” in lines 18-19, but should read “each well section including a plurality of wells, wherein each well corresponds to a head element of the plurality of head elements”
Claim 10 recites “the at least one arrangement of apertures corresponds to the plurality of head elements” in line 3, but should read “the at least one arrangement of apertures comprises a plurality of apertures, wherein each aperture corresponds to a head element of the plurality of head elements”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 9 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.
Claim 9 recites “wherein the apparatus comprises a lower tray including a plurality of well sections for retaining a plurality of allergens” in lines 17-18. However, the specification does not provide written support for the “apparatus” comprising a “lower tray”. Rather, the specification discloses the “apparatus” and “lower tray” as two separate elements, that may be part of a “kit” or “assembly”.
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 9-11 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.
Claim 9 recites “wherein the apparatus comprises a lower tray” in line 17. It is unclear as to whether this “apparatus” is referring to the previously introduced “apparatus comprising a plurality of head elements” in lines 1-2 of Claim 9, or a separate element. Examiner notes that in independent Claims 1 and 8, the “apparatus” did not encompass the “lower tray”. Rather, the “lower tray” was part of a larger “assembly” or “kit” that the “apparatus” was also a part of.
Claim 9 recites “a plurality of well sections for retaining a plurality of allergens” in lines 17-18. It is unclear as to whether this limitation is referring to the previously introduced “at least one well containing an allergen solution” in lines 4-5 of Claim 9, or a separate element.
Claim 10 recites the limitation "the orientation" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 1-5 and 8 are allowed, although claims 1 and 8 are objected to due to informalities.
Claims 10-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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 CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
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