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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 9/4/25, amended claim(s) 3, 8-9, 11-12, 15, 19-20, and 22, canceled claim(s) 4-6, 10, and 21, and new claim(s) 23 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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(s) 23 is/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.
For claim 23, the claim language “wherein the administered solution comprises an effective amount of one or more monoclonal antibodies delivered to the subject” appears to be new matter. The examiner could not find these exact terms in the specification and, although the exact same terms used in the claims do not need to be used in the specification, the examiner could not find any corollaries either. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claims.
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(s) 14-15 and 23 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.
For claim 14, the claim term “the means to encourage flow” lacks antecedent basis. The claim is examined as this term referred back to the “plunger, pump, suction mechanism, or spring-loaded pump system” in claim 12.
For claim 15, the claim term “the means to encourage flow” lacks antecedent basis. The claim is examined as this term referred back to the “plunger, pump, suction mechanism, or spring-loaded pump system” in claim 12.
For claim 23, the claim language “an effective amount of one or more monoclonal antibodies” is ambiguous. It is unclear how much of one or more monoclonal antibodies is “an effective amount,” thereby making the scope of the claim unclear. The claim is examined as meaning “one or more monoclonal antibodies.”
For claim 23, the claim term “the administered solution” lacks antecedent basis. The claim is examined as this term instead being “the administered composition.”
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 8-9, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2016/0058377 to Butte et al. (hereinafter “Butte”).
For claim 1, Butte discloses a method for determining whether a subject is allergic to an allergen (Abstract), comprising
administering to the subject’s skin at an injection site a composition comprising the allergen, wherein the composition is administered with a microneedle delivery device (Fig. 9) (para [0009]) (also see claim 1); and
monitoring the injection site of the subject’s skin for the appearance of a hypersensitivity reaction (para [0011]-[0012]),
wherein the appearance of the hypersensitivity reaction indicates that the subject is allergic to the allergen (para [0011]-[0012]).
For claim 2, Butte further discloses wherein the allergen is from a substance shown in Table 1 (para [0065]).
For claim 3, Butte further discloses wherein the allergen is a polypeptide of a length of 1 to 4 amino acids or 16 and more amino acids (para [0009] and [0050]).
For claim 8, Butte further discloses wherein a compositions is administered to the subject’s skin at a plurality of injection sites (as can be seen in Fig. 9) (para [0045] and [0047]).
For claim 9, Butte further discloses wherein a delivery device comprising a plurality of microneedles with a length of 0.5 to 1 mm is used to administer the composition (para [0041]-[0042]).
For claim 22, Butte further discloses administering to the subject an effective amount of one or more of the following: corticosteroids, calcineurin inhibitors, methotrexate, azathioprine, mycophenolate mofetil, antihistamines, or epinephrine (para [0008]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butte in view of U.S. Patent Application Publication No. 2020/0306518 to Van Der Maaden et al. (hereinafter “Van Der Maaden”).
For claim 7, Butte does not expressly disclose wherein the administering comprises a repeated motion of penetrating the microneedle delivery device into the subject’s skin at the injection site.
However, Van Der Maaden teaches wherein the administering comprises a repeated motion of penetrating the microneedle delivery device into the subject’s skin at the injection site (para [0043]).
It would have been obvious to a skilled artisan to modify Butte wherein the administering comprises a repeated motion of penetrating the microneedle delivery device into the subject’s skin at the injection site, in view of the teachings of Van Der Maaden, for the obvious advantage of faster application (see para [0043] of Van Der Maaden).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butte in view of U.S. Patent No. 6,504013 to Lawton et al. (hereinafter “Lawton”).
For claim 11, Butte does not expressly disclose wherein the injection sites are located on the subject’s legs and/or torso.
However, Gilbert teaches wherein the injection site is located on a subject’s torso (col. 13, lines 50-55).
It would have been obvious to a skilled artisan to modify Butte wherein the injection sites are located on the subject’s legs and/or torso, in view of the teachings of Gilbert, because such a location is a suitable location for which to elicit an allergic reaction.
Claim(s) 12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butte in view of U.S. Patent Application Publication No. 2008/0269635 to Mir et al. (hereinafter “Mir”).
For claim 12, Butte further discloses wherein the microneedle delivery device comprises i) one or more microneedles (Figs. 9-10).
Butte does not expressly wherein the microneedles are hollow or non-hollow, wherein one or multiple grooves are inset along an outer wall of the microneedles; and ii) a reservoir that holds the composition to be delivered, wherein the reservoir is attached to or contains a plunger, pump, suction mechanism, or spring-loaded pump system configured to encourage flow of the composition contained in the reservoir into the skin; wherein the composition is delivered into the skin by passing through the one or multiple grooves along the outer wall of the microneedle.
However, Mir teaches wherein the microneedles are hollow or non-hollow (as can be seen in Figs. 2C or 2D), wherein one or multiple grooves are inset along an outer wall of the microneedles (50) (Fig. 2D); and ii) a reservoir that holds the composition to be delivered (24) (Fig. 2D), wherein the reservoir is attached to or contains a plunger, pump, suction mechanism, or spring-loaded pump system configured to encourage flow of the composition contained in the reservoir into the skin (28) (Fig. 2D) (para [0026]); wherein the composition is delivered into the skin by passing through the one or multiple grooves along the outer wall of the microneedle (as can be seen in Fig. 2D) (para [0031]).
It would have been obvious to a skilled artisan to modify Butte wherein the microneedles are hollow or non-hollow, wherein one or multiple grooves are inset along an outer wall of the microneedles; and ii) a reservoir that holds the composition to be delivered, wherein the reservoir is attached to or contains a plunger, pump, suction mechanism, or spring-loaded pump system configured to encourage flow of the composition contained in the reservoir into the skin; wherein the composition is delivered into the skin by passing through the one or multiple grooves along the outer wall of the microneedle, in view of the teaching of Mir, for the obvious advantage of allowing control over “a quick or a slow release of the allergens” (see para [0031] of Mir).
For claim 14, Butte, as modified, further discloses wherein the means to encourage flow of the composition contained in the reservoir into the skin is selected from the group consisting of a plunger, pump and suction mechanism (para [0026] of Mir).
For claim 15, Butte, as modified, further discloses wherein the means to encourage flow of the composition contained in the reservoir into the skin is a mechanical spring-loaded pump system (para [0026] of Mir).
Claim(s) 16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butte in view of Mir, and further in view of U.S. Patent Application Publication No. 2016/0175408 to Chang et al. (hereinafter “Chang”).
For claim 16, Butte and Mir do not expressly disclose wherein the microneedles have a single groove inset along the outer wall of the microneedle, wherein the single groove has a screw thread shape going clockwise or counterclockwise around the microneedle.
However, Chang teaches wherein the microneedles have a single groove inset along the outer wall of the microneedle (see Figs. 4 and 10), wherein the single groove has a screw thread shape going clockwise or counterclockwise around the microneedle (see Figs. 4 and 10).
It would have been obvious to a skilled artisan to modify Butte wherein the microneedles have a single groove inset along the outer wall of the microneedle, wherein the single groove has a screw thread shape going clockwise or counterclockwise around the microneedle, in view of the teachings of Chang, because such a modification would be the simple substitution of the shape of the groove that would lead to the predictable result of providing a path by which to delivery the allergen. Also see In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
For claim 18, Butte and Mir do not expressly disclose wherein the microneedles are made from a substance comprising gold.
However, Chang teaches wherein the microneedles are made from a substance comprising gold (para [0487]-[0488]).
It would have been obvious to a skilled artisan to modify Butte wherein the microneedles are made from a substance comprising gold, in view of the teachings of Chang, for the obvious advantage of resisting corrosion from skin oils.
For claim 19, Butte and Mir do not expressly disclose wherein the plurality of microneedles comprises an array of microneedles in the shape of a circle.
However, Chang teaches wherein the plurality of microneedles comprises an array of microneedles in the shape of a circle (Fig. 4) (para [0467]).
It would have been obvious to a skilled artisan to modify Butte wherein the plurality of microneedles comprises an array of microneedles in the shape of a circle, in view of the teachings of Chang, because such a modification would be the simple substitution of the shape of the array that would lead to the predictable result of interrogating the patient’s skin. Also see In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
For claim 20, Butte and Mir do not expressly disclose wherein the microneedles are made of 24-carat gold plated stainless steel and comprise an array of 20 microneedles.
However, Chang teaches wherein the microneedles are made of 24-carat gold plated stainless steel (para [0487]-[0488]) and comprise an array of 20 microneedles (para [0487]-[0488]).
It would have been obvious to a skilled artisan to modify Butte wherein the microneedles are made of 24-carat gold plated stainless steel and comprise an array of 20 microneedles, in view of the teachings of Chang, for the obvious advantage of resisting corrosion from skin oils.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butte in view of U.S. Patent Application Publication No. 2004/0037776 to Lacharriere et al. (hereinafter “Lacharriere”).
For claim 23, Butte does not expressly disclose wherein the administered solution comprises an effective amount of one or more monoclonal antibodies delivered to the subject.
However, Lacharriere teaches one or more monoclonal antibodies delivered to the subject (para [0066]).
It would have been obvious to a skilled artisan to modify Butte wherein the administered solution comprises an effective amount of one or more monoclonal antibodies delivered to the subject, in view of the teachings of Lacharriere, as an additional way or a substitutional way to elicit a response from the skin of the patient so that a diagnosis can be performed.
Response to Arguments
Applicant’s arguments filed 9/4/25 have been fully considered. Although many of Applicant’s arguments are moot due to the new grounds of rejection necessitated by the amendments to the claims, the arguments regarding claim 1 are not persuasive because they are not commensurate in scope with the claim language. Claim 1 does not recite the term “dissolvable.” Additionally, claim 1 uses the transitional phrase “comprising” indicating that the claim language is open such that the prior art may have more than one composition and still read on the scope of the claim language since the claim language is open. The arguments regarding claim 8 also suffer from the same deficiency and the examiner submits the same response. The rest of the arguments regarding the 102 rejection are directed to new grounds of rejections. With respect to claim 7, the argument doesn’t address the proposed advantage of the modification. Para [0043] of Van Der Maaden explicitly states that repeated motion reduces time of application, and this is true of a single assay or multiple assays. Therefore, the fact of using a single assay doesn’t seem material to the advantage proposed by Van Der Maaden. With respect to claim 12, Butte expressly states “a microneedle array, including without limitation a dissolving microneedle array” (see para [0009] of Butte). Therefore, the dissolvability is not a limitation of Butte. With respect to claims 14-15 and 16 and 18-20, the examiner submits the same response, that the dissolvability is not a limitation of Butte.
Conclusion
THIS ACTION IS MADE FINAL. 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791