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 October 28th, 2025, amended claims 1-3 and 7-9 are entered. Claim 6 is canceled.
Claim Rejections - 35 USC § 112
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 9 is 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.
The terms “slightly” and “substantial” in claim 9 are relative terms which render the claim indefinite. The terms “slightly” and “substantial” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hsiao (U.S. Patent No. 6,024,706) in view of Smollar (U.S. Publication No. 2015/0289794; cited by Applicant).
Regarding Claim 1, Hsiao discloses an assembly for allergy testing (Quantitative skin allergic test device; Abstract), the assembly comprising:
at least one apparatus having a plurality of head elements (stem 16), each head element comprising four pressure tips (raised portions 18) and four piercing tips (puncturers 20) arranged in a single circle (a raised portion 18 formed at the end of the elongated stem 16 whereas there are a plurality of puncturers 20, which are capable of carrying a certain amount of antigen liquid 24 by capillary phenomenon, provided around the raised portion 18 (see FIG. 6 and FIG. 9). As shown in FIG. 9, the puncturers 20 are provided at the end of the elongated stem 16, substantially parallel to the axis of the raised portion 18 as well as the longitudinal axis of the elongated stem 16; Column 3 Lines 7-15), wherein each of the pressure tips is between two piercing tips and each of the piercing tips is between two pressure tips, each head element further comprising a fifth piercing tip at a center of the circle (FIG. 7 and FIG. 8 show alternative embodiments of the skin allergic test device according to the present invention, where the raised portions 18 are formed with different configurations and arrangements, and they are also act as stops to limit an over penetration; Column 4 Lines 1-5; Examiner’s Note: Figure 7 shows four raised portions 18, equivalent to the four pressure tips and four puncturers 20 arranged in a single circle, wherein each of the raised portions 18 is between two puncturers 20 and each of the puncturers 20 is between two raised portions 18, and further comprising a fifth piercing tip at the center of the circle);
a lower tray including a plurality of well sections for retaining a plurality of allergens (The tray 60 has a plurality of round holes 63 formed on the upper surface thereof for facilitating allergy tests. Each round hole 63 of the tray 60 is capable to hold an antigen container 22 of the present invention; Column 5 Lines 45-49), the well sections including a plurality of wells corresponding to the plurality of head elements (The amount and positions of the round holes 63 are so designed that, when taking a multileg skin-allergic testing device as which shown in FIGS. 10 or 11 to mate with the tray 60, each leg of the multileg skin-allergic testing device will exactly locate in a round hole 63 of the tray 60. Therefore, by placing a plurality of antigen containers 22 into the round holes 63 of the tray 60, the various kinds of antigen solutions contained within the containers 22 may be easily and rapidly applied on different legs of the multileg skin-allergic testing device in a simultaneously manner; Column 5 Lines 53-63).
Hsiao fails to teach a cover for removable attachment to the lower tray; and a top tray for retaining the apparatus, wherein the cover, upon attachment to the lower tray, retains the top tray and the at least one apparatus therebetween.
In a similar technical field, Smollar teaches an allergy skin test applicator, and related testing tray, testing kit and testing method (Abstract), comprising a cover for removable attachment (The allergy test case includes a cover 30 configured to releasably engage the main body or lower portion 31 of the allergy case 20 (see FIG. 10). The cover 30 can interface with the lower portion 31 of the allergen case 20 in any number of ways, such as a latch; [0066]) to the lower tray (The allergy test case 20 provides a main body 31 having an applicator engaging surface 21 (see FIGS. 8 and 13A); [0063]); and
a top tray for retaining the apparatus (To improve a sealing quality of the test case, a flexible seal 35 (see FIG. 14A) is positioned along the entire circumference of the lower portion 31 of the test case 20 so that when the cover 30 is locked, the seal 35 engages with a flange 36 that extends downwardly from the cover 30 so as to create a sealing engagement (see also FIGS. 13& 13A); [0067]),
wherein the cover, upon attachment to the lower tray, retains the top tray and the at least one apparatus therebetween (The allergy test case includes a cover 30 configured to releasably engage the main body or lower portion 31 of the allergy case 20 (see FIG. 10). The cover 30 can interface with the lower portion 31 of the allergen case 20 in any number of ways, such as a latch. In the preferred embodiment a pivoted latch 32 (see FIG. 11) is configured to engage with a flange 33 (see FIG. 14) located on a base 34 of the case 20 (see FIG. 14). To improve a sealing quality of the test case, a flexible seal 35 (see FIG. 14A) is positioned along the entire circumference of the lower portion 31 of the test case 20 so that when the cover 30 is locked, the seal 35 engages with a flange 36 that extends downwardly from the cover 30 so as to create a sealing engagement (see also FIGS. 13& 13A). The bottom of the allergy test case has raised, non-slip members or feet 37 for secure placement of the case on a surface; [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the allergy case teachings of Smollar into the invention of Hsiao in order to ensure that the testing trays are covered in a sealed fashion to ensure that the allergens will not be easily exposed to contamination, to reduce evaporation, and to provide secure sealing to prevent accidental mishandling by the medical personnel (Smollar [0003-0004]).
Regarding Claim 2, Hsiao discloses wherein the apparatus includes two rows of head elements and the plurality of head elements comprises eight head elements (Figure 11).
Regarding Claim 3, Hsiao discloses wherein the plurality of head elements comprises twelve head elements (it will be possible to design an improved multileg skin-allergic testing device which has many legs, for example, twelve legs or even more than twelve legs, while the reliability and accuracy of the skin allergic test result can still be ensured; Column 5 Lines 15-19).
Hsiao fails to teach wherein the apparatus includes three rows of head elements.
In a similar technical field, Smollar teaches an allergy skin test applicator, and related testing tray, testing kit and testing method (Abstract), wherein the apparatus includes three rows of head elements (Examiner’s Note: Figures 5-6 show the rear view and front view of the allergy testing applicator, which shows that there are three rows of head elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the arrangement teachings of Smollar into the invention of Hsiao in order to reduce human error in the administration of the test by registering a clear record of the test sites even if the applicator is mistakenly reversed in direction when applied to the skin (Smollar [0009]).
Regarding Claim 4, Smollar further teaches wherein a middle one of the three rows is displaced relative to an outer two of the three rows (The arms 5 are disposed in an asymmetric configuration around the handle 2; [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the asymmetrical arrangement teachings of Smollar into the invention of Hsiao in order to reduce human error in the administration of the test by registering a clear record of the test sites even if the applicator is mistakenly reversed in direction when applied to the skin (Smollar [0009]).
Regarding Claim 5, Hsiao discloses wherein the apparatus includes two rows of head elements (Figure 11).
Regarding Claim 7, Hsiao discloses wherein each of the pressure tips comprises a rounded end (Examiner’s Note: Figures 4 and 6-9 show that each of the raised portions 18 comprise a rounded end).
Regarding Claim 8, Hsiao discloses a kit for allergy testing (Quantitative skin allergic test device; Abstract),the kit comprising:
at least one apparatus having a plurality of head elements (stem 16), each head element comprising four pressure tips (raised portions 18) and four piercing tips (puncturers 20) arranged in a single circle (a raised portion 18 formed at the end of the elongated stem 16 whereas there are a plurality of puncturers 20, which are capable of carrying a certain amount of antigen liquid 24 by capillary phenomenon, provided around the raised portion 18 (see FIG. 6 and FIG. 9). As shown in FIG. 9, the puncturers 20 are provided at the end of the elongated stem 16, substantially parallel to the axis of the raised portion 18 as well as the longitudinal axis of the elongated stem 16; Column 3 Lines 7-15), wherein each of the pressure tips is between two piercing tips and each of the piercing tips is between two pressure tips, each head element further comprising a fifth piercing tip at a center of the circle (FIG. 7 and FIG. 8 show alternative embodiments of the skin allergic test device according to the present invention, where the raised portions 18 are formed with different configurations and arrangements, and they are also act as stops to limit an over penetration; Column 4 Lines 1-5; Examiner’s Note: Figure 7 shows four raised portions 18, equivalent to the four pressure tips and four puncturers 20 arranged in a single circle, wherein each of the raised portions 18 is between two puncturers 20 and each of the puncturers 20 is between two raised portions 18, and further comprising a fifth piercing tip at the center of the circle);
a lower tray comprising a plurality of well sections for retaining a plurality of allergens (The tray 60 has a plurality of round holes 63 formed on the upper surface thereof for facilitating allergy tests. Each round hole 63 of the tray 60 is capable to hold an antigen container 22 of the present invention; Column 5 Lines 45-49), the well sections providing a plurality of wells corresponding to the plurality of head elements (The amount and positions of the round holes 63 are so designed that, when taking a multileg skin-allergic testing device as which shown in FIGS. 10 or 11 to mate with the tray 60, each leg of the multileg skin-allergic testing device will exactly locate in a round hole 63 of the tray 60. Therefore, by placing a plurality of antigen containers 22 into the round holes 63 of the tray 60, the various kinds of antigen solutions contained within the containers 22 may be easily and rapidly applied on different legs of the multileg skin-allergic testing device in a simultaneously manner; Column 5 Lines 53-63).
Hsiao fails to teach a cover that is securely attachable to the lower tray; and a top tray for securely situating the apparatus, wherein the cover is removably attachable to the lower tray and situates the top tray along with the apparatus therebetween.
In a similar technical field, Smollar teaches an allergy skin test applicator, and related testing tray, testing kit and testing method (Abstract), comprising a cover that is securely attachable to the lower tray (The allergy test case includes a cover 30 configured to releasably engage the main body or lower portion 31 of the allergy case 20 (see FIG. 10). The cover 30 can interface with the lower portion 31 of the allergen case 20 in any number of ways, such as a latch; [0066]); and
a top tray for securely situating the apparatus (To improve a sealing quality of the test case, a flexible seal 35 (see FIG. 14A) is positioned along the entire circumference of the lower portion 31 of the test case 20 so that when the cover 30 is locked, the seal 35 engages with a flange 36 that extends downwardly from the cover 30 so as to create a sealing engagement (see also FIGS. 13& 13A); [0067]),
wherein the cover is removably attachable to the lower tray and situates the top tray along with the apparatus therebetween (The allergy test case includes a cover 30 configured to releasably engage the main body or lower portion 31 of the allergy case 20 (see FIG. 10). The cover 30 can interface with the lower portion 31 of the allergen case 20 in any number of ways, such as a latch. In the preferred embodiment a pivoted latch 32 (see FIG. 11) is configured to engage with a flange 33 (see FIG. 14) located on a base 34 of the case 20 (see FIG. 14). To improve a sealing quality of the test case, a flexible seal 35 (see FIG. 14A) is positioned along the entire circumference of the lower portion 31 of the test case 20 so that when the cover 30 is locked, the seal 35 engages with a flange 36 that extends downwardly from the cover 30 so as to create a sealing engagement (see also FIGS. 13& 13A). The bottom of the allergy test case has raised, non-slip members or feet 37 for secure placement of the case on a surface; [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the allergy case teachings of Smollar into the invention of Hsiao in order to ensure that the testing trays are covered in a sealed fashion to ensure that the allergens will not be easily exposed to contamination, to reduce evaporation, and to provide secure sealing to prevent accidental mishandling by the medical personnel (Smollar [0003-0004]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smollar in view of Hsiao and Harish (U.S. Publication No. 2016/0206333).
Regarding Claim 9, Smollar discloses a method of administering an allergy test by means of an apparatus having at least one head element (Allergy skin test applicator, and related testing tray, testing kit and testing method; Abstract), the method (The testing method is now described in detail with the following steps; [0072]) comprising:
placing the at least one head element into at least one well containing an allergen solution to load the allergen solution onto the head element (9. Insert a matching number of asymmetrical applicators 1 into the reservoir openings 26, thereby loading the allergenic material on the tips 7 of the applicators 1; [0081]); and
administering the allergen solution to a skin surface of a patient by pressing the apparatus against the skin surface such that said head element delivers the allergen solution (10. Using the applicators 1 that have been loaded with allergenic agents via the reservoir, perform the intended multiple sites skin test (e.g. apply each applicator 1 to the skin of the patient); [0082]),
wherein the at least one head element comprises four piercing tips (Leg like structures 6 extend downwardly from each of the arms 5. At a lower end of each leg 6 is a multiplicity of finely formed tines 7 that constitute the portion of the applicator 1 that engages with a patient's skin; [0057]; Figure 3).
Smollar fails to teach wherein the at least one head element comprises four pressure tips and four piercing tips arranged in a single circle, wherein each of the pressure tips is between two piercing tips and each of the piercing tips is between two pressure tips, each head element further comprising a fifth piercing tip at a center of the circle, wherein each of the pressure tips has a rounded end, wherein each of the pressure tips is slightly shorter than each of the plurality of piercing tips.
In a similar technical field, Hsiao teaches a quantitative skin allergic test device (Abstract), wherein the at least one head element comprises four pressure tips (raised portions 18) and four piercing tips (puncturers 20) arranged in a single circle (a raised portion 18 formed at the end of the elongated stem 16 whereas there are a plurality of puncturers 20, which are capable of carrying a certain amount of antigen liquid 24 by capillary phenomenon, provided around the raised portion 18 (see FIG. 6 and FIG. 9). As shown in FIG. 9, the puncturers 20 are provided at the end of the elongated stem 16, substantially parallel to the axis of the raised portion 18 as well as the longitudinal axis of the elongated stem 16; Column 3 Lines 7-15), wherein each of the pressure tips is between two piercing tips and each of the piercing tips is between two pressure tips, each head element further comprising a fifth piercing tip at a center of the circle (FIG. 7 and FIG. 8 show alternative embodiments of the skin allergic test device according to the present invention, where the raised portions 18 are formed with different configurations and arrangements, and they are also act as stops to limit an over penetration; Column 4 Lines 1-5; Examiner’s Note: Figure 7 shows four raised portions 18, equivalent to the four pressure tips and four puncturers 20 arranged in a single circle, wherein each of the raised portions 18 is between two puncturers 20 and each of the puncturers 20 is between two raised portions 18, and further comprising a fifth piercing tip at the center of the circle),
wherein each of the pressure tips has a rounded end (Examiner’s Note: Figures 4 and 6-9 show that each of the raised portions 18 comprise a rounded end),
wherein each of the pressure tips is slightly shorter than each of the plurality of piercing tips (the puncturers 20 each have a length greater than the height of the raised portion 18 by a predetermined value which is less than the thickness of the epidermis layer of the skin of human beings. Desirably, the length of each puncturer 20 is designed to project out the raised portion 18 by about 0.1 mm to about 0.5 mm, so that the epidermis layer of a patient will not be penetrated by the puncturers 20 while conducting a skin allergic test since the raised portion 18 is act as a stop to limit excessive penetration of the puncturers 20, which is the most important guideline that a technician or practitioner is required to obey in order to obtain an accurate interpretation of the test result and to make the test data reproducible and assure the test reliability; Column 3 Lines 15-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pressure tips teachings of Hsiao into the invention of Smollar in order to limit excessive penetration of the puncturers, which is the most important guideline that a technician or practitioner is required to obey in order to obtain an accurate interpretation of the test result and to make the test data reproducible and assure the test reliability (Hsiao Column 3 Lines 22-27).
Although Hsiao teaches pressure tips, Smollar and Hsiao fail to specifically recite the activation of nerve tissue of the patient to suppress pain thereby resulting in a substantial reduction of pain during testing.
In a similar technical field, Harish teaches allergy skin test devices with surrounding pain-reduction structures (Abstract), wherein the activation of nerve tissue of the patient suppresses pain thereby resulting in a substantial reduction of pain during testing (the dull probes being for activating a pain gate effect in nerves of the skin; [0004], [0010], [0015], [0018]; The at least three dull probes, or the flat end, or the bumpy end, provides a surround-effect that creates a “pain-gate fence” substantially surrounding an area of sharp probe penetration that would be painful if not blocked by the surrounding pain-gate fence. The pain-gate fence is also referred to as PAIN FENCE™ technology. A pain-gate fence is any arrangement of pain-gates that substantially block or inhibit pain signals that tend to not be blocked by a single dull probe; [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the pain suppression teachings of Harish into those of Smollar and Hsiao, as it is well-known in the field of allergy skin testing that the application of pressure substantially blocks and/or inhibit pain signals caused by the allergen administering sharp probes (Harish [0003]).
Conclusion
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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/CHANEL J YOON/Examiner, Art Unit 3791