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 .
Election/Restrictions
Applicant’s election of Group I, claim(s) 1-5, 7-8, 10-14, and 16 in the reply filed on 08/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s species election of (I) a method of treating adult-onset asthma (AOA) as the method of treating or preventing directed to a single disease or condition and (II) "targeting the HLA-DQA2 and/or HLA- DQB2 genes and reducing expression thereof” (claim 7) as the method of inhibiting in the reply filed on 08/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3-5, 11-14, and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Claims 6, 9, 15, 17-28 are canceled.
Claims 1-5, 7-8, 10-14, and 16 are pending.
Claims 1-2, 7-8 and 10 are under examination on the merits.
Priority
This application 18/565,970 filed on 11/30/2023 is a 371 national phase of PCT/US2022/033442 filed on 06/14/2022, and claims the benefit of provisional U.S. Patent Application No. 63/210,343, filed on 06/14/2021.
The priority date of claim1 and its dependent claims is determined to be 06/14/2021, the filing date of provisional U.S. Patent Application No. 63/210,343.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
See Figs. 1A-C, 2A-C, 3A-C, 4, 5A-C, 8, 9A-F and 10A-B.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See p. 51 of specification dated 11/30/2023.
The use of terms which are trade names or marks used in commerce (including IIlumina® and 10x Genomics® among others), 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.
Claim Interpretation
Claim 1 recites a method “of treating or preventing adult-onset asthma (AOA) or another disease or condition” in the preamble. This limitation is an intended result of performing the active step of the claimed method. Claim 1 further recites the active step “inhibiting the activity and/or the expression of human leukocyte antigen (HLA) class II histocompatibility antigen, DQ alpha 2 chain (HLA-DQA2) and/or HLA class II histocompatibility antigen, DQ beta 2 chain (HLA-DQB2)”. Under broadest reasonable interpretation the claim requires only inhibiting the activity and/or the expression of the recited genes.
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.
Claims 1-2, 7-8, and 10 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.
Regarding claim 1, it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites a “method of treating or preventing adult-onset asthma (AOA) or another disease or condition”. However, the method steps in the claim only require “inhibiting the activity and/or the expression of
human leukocyte antigen (HLA) class II histocompatibility antigen, DQ alpha 2 chain (HLA-DQA2) and/or HLA class II histocompatibility antigen, DQ beta 2 chain (HLA-DQB2)”. Thus, it is unclear if applicant intends to cover any method of inhibiting HLA-DGA2 and/or HLA-DQB2 expression or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the latter, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal of treating or preventing adult-onset asthma (AOA) or another disease or condition as set forth by the preamble of the claim. Amending the claim to include an active process step directed towards active process step directed towards administering a treatment to a subject or patient would be helpful.
Claims 2, 7, 8, and 10 are similarly indefinite because they directly or indirectly depend from claim 1.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7-8, and 10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Alper et al.(WO2008134729, on IDS dated 03/03/2025).
Regarding claim 1, Alper teaches a method of developing therapeutic and diagnostic targets using HLA-DQ A2 (Abstract), the method comprising inhibiting HLA-DQA2 transcription or translation (para 15)
Regarding claim 7, Alper teaches interrupting, preventing or reducing the transcription or translation of the HLA-DQ A2 gene (para 27), which reads on targeting the HLA-DQA2 gene and reducing expression thereof.
Regarding claims 8 and 10, Alper teaches administering an agent for inhibiting HLA-DQA2, wherein the agent can be an siRNA molecule (para 15 and claim 15), which reads on reducing expression comprises a nucleic acid inhibitor of gene expression (claim 8) and targeting comprises knocking down expression by RNAi (claim 10).
Claim Rejections - 35 USC § 103
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 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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Alper et al.(WO2008134729, on IDS dated 03/03/2025) in view of Lenormand et al. (“HLA-DQA2 and HLA-DQB2 Genes Are Specifically Expressed in Human Langerhans Cells and Encode a New HLA Class II Molecule", The Journal of Immunology, 15 April 2012, Vol. 188, No. 8, pp. 3903-3911.On IDS dated 03/03/2025).
The teachings of Alper as they relate to claim 1 are stated in the 102 rejection above in this office action.
Regarding claim 2, Alper teaches inhibition of expression in a cell (para 27), but is silent regarding the type of cell and does not teach inhibiting the activity and/or the expression of HLA- DQA2 and/or HLA-DQB2 in lung epithelial cells and/or Langerhans cells.
Lenormand teaches HLA-DQA2 expression in Langerhans cells (Abstract and Fig. 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Alper and Lenormand to arrive at the instantly claimed invention. The modification would have entailed performing the method of Alper to inhibit HLA-DGA2 in the cells identified by Lenormand. One of skill in the art would have been motivated to perform the inhibition of HLA-DQA2 as taught by Alper in the cells identified by Lenormand in order to target inhibition of expression to cells known to express the gene for efficacy of inhibition and to limit toxicity. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA GRAY whose telephone number is (571)272-0116. The examiner can normally be reached Monday-Friday 8-5 with second Fridays off.
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, WINSTON SHEN can be reached at (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
Prosecution Insights