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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on October 6, 2025 has been entered. By way of this submission, Applicant has amended claims 17 and 28.
Claims 17, 21, 23-26, and 28 are pending in the application. Claims 21, 23 and 25-26 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed July 11, 2023.
Claims 17, 24 and 28 are therefore under examination before the Office.
The rejections of record can be found in the Examiner's Answer to Appeal Brief, dated November 4, 2024.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17, 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Gruhne (US20190049461A1) in view of Wai (Journal of Allergy and Clinical Immunology 143.2: AB270, cited previously) and Yang (J Allergy Clin Immunol. 2010 Apr;125(4):872-8).
Gruhne teaches that IgE crosslinking tests and basophil activation tests are useful in detecting allergies; specifically, contact with the allergen results in increased IgE crosslinking. (para. 0006-0008). Gruhne also teaches that skin prick tests are useful in diagnosing allergies (para. 0002).
Gruhne further teaches that the allergen may be a shrimp allergen (para. 0060).
Gruhne further teaches a method for treating an allergy, comprising (1) detecting activated basophils, and (2) if activated basophils are detected, administering to the patient an effective amount of a therapeutic agent or treatment (para. 0095). Gruhne further teaches that the treatment may be an antihistamine, a steroid, or an immunotherapy (para. 0099), and that the treatment may be taken by mouth (i.e., orally) (para. 0100), which is pertinent to claim 28.
However, Gruhne does not teach troponin C or a wheal of at least 3mm in diameter.
Wai teaches that a wheal of at least 3 mm is indicative of a positive skin prick test for allergy (Section 821: "Methods"). Wait further teaches several shellfish allergens, including troponin C (TnC) and fatty-acid-binding protein (FABP) (Section 821: "Methods").
Wai further teaches evaluation of IgE sensitivity as a follow-up to a skin prick test (Section 821: "Rationale").
Yang teaches the use of both skin prick tests and IgE response to detect an allergic response to the blacktiger prawn (Penaeus monodon) (page 873, left column, first paragraph), which is pertinent to claim 24.
Yang further teaches that using measurements of IgE to shrimp allergens improved diagnostic specificity to conventional methods for allergy diagnosis (page 874, right column, last paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Gruhne, Wai, and Yang to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since Gruhne, Wai, and Yang are all concerned with diagnosis of shrimp allergies. Starting of the methods of diagnosis and treatment described by Gruhne, one of skill in the art could apply the teachings of Wai to use TnC and FABP as the allergens in the diagnostic steps of Gruhne, including the evaluation of a wheal of at least 3 mm in size. Wai and Yang also describe an advantage of using both skin prick test and IgE crosslinking to confirm specific shrimp allergies. Each component in the combination would perform its known, usual function, and the combination would have yielded nothing more than predictable results.
Applicant argues that prima facie obviousness is rebutted by the Declaration under rule 1.132 by the inventor Dr. Ting Fan Leung ("the Second Leung Declaration"), filed October 6, 2025. Specifically, Applicant argues that the Second Leung Declaration states that the claimed two-step method of increases diagnostic sensitivity and specificity is both significant and surprising in view of the cited references.
Applicant's arguments have been considered fully but are not found to be persuasive.
Claims 17 and 24 are substantially identical to the claims that were found to be obvious unpatentably obvious over Gruhne in view of Wai and Yang in the decision of the Patent Trial and Appeal Board on September 16, 2025. Applicant is precluded from seeking a claim that is not patentably distinct from a claim that was finally refused or canceled during an administrative trial or federal court proceeding under the doctrine of res judicata. MPEP 2190.
As stated previously, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). MPEP 716.02(a)(1). Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof. In re Gershon, 372 F.2d 535,538, 152 USPQ 602, 604 (CCPA 1967). MPEP 716.02(c).
The benefits of combining two known allergy tests to achieve greater diagnostic accuracy is predicted by Yang. Yang at page 874, right column, last paragraph: “In the present study we demonstrated that measurements of IgE levels to shrimp tropomyosin provided added diagnostic value to the current available methods for confirming shrimp allergy in patients with suspected reactions on ingestion of shrimp. In particular, using measurement of IgE to shrimp tropomyosin improved diagnostic specificity, PPV, and efficiency for prediction of a clinically relevant reaction to shrimp.”
When an applicant timely submits evidence traversing a rejection, the examiner must reconsider the patentability of the claimed invention. The ultimate determination of patentability must be based on consideration of the entire record, by a preponderance of evidence, with due consideration to the persuasiveness of any arguments and any secondary evidence. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). The submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed. Cir. 1987). Facts established by rebuttal evidence must be evaluated along with the facts on which the conclusion of a prima facie case was reached, not against the conclusion itself. In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). MPEP 716.01(d).
Here, the evidence presented in the Second Leung Declaration is in conflict with the teachings of Yang. Yang recognizes that the use of multiple testing methods to accurately diagnose shrimp allergy enhances specificity. However, the Second Leung Declaration states that the benefit of the claimed combination is unexpected. While Dr. Leung may assert that the benefit of the combination is unexpected, paragraph 9 of the Second Leung Declaration attempts to state a legal conclusion, which is not given any evidentiary weight. MPEP 716.01(III).
Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). MPEP 716.02(c).
In the instant case, the unexpected properties of the claimed invention do not have significance equal to or greater than the expected properties. Yang makes it clear that combinations of tests provide increased diagnostic accuracy for shrimp allergy. The Second Leung Declaration does not provide new evidence besides restating what had been previously presented in the First Leung Declaration. When weighing the teachings of Yang against the Second Leung Declaration, the preponderance of the evidence suggests that the results are not unexpected. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977).
It is also noted that this argument was found unpersuasive in the above Patent Trial and Appeal Board decision at pages 7-8.
This rejection is therefore maintained.
Claim Rejections - 35 USC § 101
Claims 17 and 24 were previously rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 8:00 to 4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/ Examiner, Art Unit 1644
/DANIEL E KOLKER/ Supervisory Patent Examiner, Art Unit 1644