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 .
Applicant filed response on 12/4/2025 has been received.
Claims 1-14 are pending. Claims 10-14 are withdrawn from further consideration.
Claims 1-9 are under examination.
The rejection on Claim(s) 1-3, 5 and 6-9 under 35 U.S.C. 103(a) as being unpatentable by Akinori (JP 2006143700; IDS reference; English translation) in view of Joseph (US 20150211012), Ye (US 20190307686) or Conceicao (US 20120328621) is withdrawn because secondary referencs Joseph, Ye, or Conceicao do not provide proper suggestion or motivation to switch ELISA to do-blot.
Accordingly, the rejection on Claim(s) 4 under 35 U.S.C. 103 as being unpatentable over Akinori in view of Joseph, Ye or Conceicao as applied to claims 1-3, 5 and 6-9 above, and further in view of Gardosa (US 6759517) is withdrawn.
However the main Akinori reference still remains proper in combining different secondary reference to reach the current invention (see below).
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims 1 and 2 in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
As to claim 1 and 2, the wording “configured” in the specification section 0052, is a membrane known in the field for immobilizing allergen (including proteins) thereon, such as PVDF, nitrocellulose or other membrane capable of support allergens thereon.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9 are rejected under 35 U.S.C. 103(a) as being unpatentable by Akinori in view of Handzel (US 5597735), Wands (US 20070042437), Glaser (US 20100150920) and Wongkamchai (Allergology International 2000 49:151-155).
Akinori teaches a method of evaluating allergen inactivators using immunoassay methodology. Akinori teaches using ELISA plate having allergen coated there on followed with different potential allergen inactivator drugs, e.g. ginkgo, yellowchin leaves, tea leaves, lemon balm leaves, cabbage loses flowers and buds, and peanut astringent skin. An allergen specific monoclonal antibody is applied followed by horse peroxidase labeled (protein staining agent) for quantification to extent to which the allergens are inactivated by the above potential test agents, such as ginkgo, yellowchin leaves, tea leaves, lemon balm leaves, cabbage loses flowers and buds, and peanut astringent skin (See section 0049-0068; Table 1 and Table 2). Note, the term “test drug” under broadest reasonable interpretation encompass the tested agents ginkgo, yellowchin leaves, tea leaves, lemon balm leaves, cabbage loses flowers and buds, and peanut astringent skin. In addition, with respect to claim 2, there is no addition of test drugs to the second membrane, this can be considered as a control (without test drugs) vs. experimental group (with test drugs).
The difference between the current invention and that of Akinori is that Akinori uses ELISA to coat the plate with allergen specific antibodies followed by adding allergens and test drugs, whereas the current invention uses dot-blot assay, i.e. a step for preparing an allergen-supporting membrane configured by supporting allergens on the membrane, adding test drug followed by applying allergen specific antibody. Nevertheless, both use the same principle, i.e. allergen-allergen specific antibody binding. Moreover dot-blot has been developed because of some advantages for handling in the laboratory (see below).
For instance, Handzel studied infectious disease allergens (e.g. tuberculosis). Handzel performed parallel ELISA and dot-blot assays, and concluded “ELISA system can be advantageously replaced by Dot-Blot method” (Col. 14, line 5-10)(emphasis added). This shows that dob-blot is both compatible and even more easier to handle than ELISA.
In addition, Wands teaches that the use of dot-blot analysis requires less time, permit high throughput, prevent carryover contamination (section 0091).
Moreover, Glaser teach that dot-blot format provides advantages of high density and minimal amounts of sample materials for the assay (section 0034).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use alternative dot-blot assays as taught by Handzel, Wands and Glaser for assessing the allergen inactivators by taking advantages in less amount for high throughput, less-time consuming with reasonable expectation of success.
As to the features of preparing allergen-supporting membrane, adding allergen antibodies followed by detection and assessing the extent of allergen are inactivated by the test drug (e.g. less signals), these steps are known and practiced in dot-blot.
As to the washing step, although Akinori does not explicitly teach this step, nevertheless it would have been prima facie obvious to one ordinary skilled person to do so for (1) washing step for removing residual drugs after test drug treating on the membrane having allergens thereon; (2) similarly washing step for removing excessive antibodies after applying allergen antibodies on the membrane because these steps fall within routine practice by removing undesired or unnecessary interference due to residual test drugs and allergen antibodies for a better yield or more accurate analysis.
For instance, Wongkamchai teaches using dot-blot for detecting house dust mite allergens (see Title, Abstract, Materials and Methods). Wongkamchai teaches washing extra unbound dust extract with PBS for 10 seconds from the test strip (membrane), and another washing mAb antibody from the test strip for about 10 seconds (see “Performance of the dot-blot assay”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the unbound test drug and excess antibody from the membrane to reduce interference for better detection results. The washing steps are known and commonly practiced in the field.
As to claim 3-4, Handzel uses protein A conjugates for staining purpose (Col. 13, Materials and Methods).
As to claim 5, Handzel uses nitrocellulose as membrane (Col. 13, “Materials and Methods).
As to claim 6-9, the nitrocellulose membrane in dot-blot provides pluralities of locations for applying samples, applying detection antibodies and observations of results.
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678