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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, 11, drawn to a lateral flow device pump housing, classified in B01L3/5023.
II. Claims 9-10, drawn to a lateral flow device pump housing, classified in B01L3/5023.
III. Claims 12-20, drawn to a method of making a lateral flow device, classified in B01L2200/12.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed group I requires a cup nested inside a cavity, group II does not require a cup nested inside a cavity. Group II requires a pump cover that is attached to the base with spring loaded hooks, group I does not require a pump cover attached to the base with spring loaded hooks. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions I and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case group III requires the step of providing a pump, where group I does not require providing a pump.
Inventions II and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case group III requires the step of attaching a cup side wall to a pump housing side wall, group II does not require this step as group II does not include a cup.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species: a cup side wall being attached to a pump housing side wall by an adhesive, a solvent bond, ultrasonication, laser weld, rivets, screws, or ratchet teeth. The species are independent or distinct because each attachment type is understood to be mutually exclusive. On page 3 lines 10-15 of the instant specification it recites “In some embodiments, the cup side wall is attached to the pump housing side wall by heat welding, adhesive bonding, solvent bonding, ultrasonication, or laser welding. In some cases, the cup side wall is attached to the pump housing side wall with rivets or screws. In certain embodiments, the cup side wall is attached to the pump housing side wall by a complementary side wall by a complementary ratchet-like feature molded into the cup side wall and the pump housing side wall.” From this section, it is understood that the different ways of attachment cannot be combined together, as this section lists alternative ways to attach the two components in different embodiments. Further, within embodiments such as the one using heat welding, adhesive bonding, solvent bonding, ultrasonication, or laser welding, usage of the word “or” indicates that it is one of the five listed and not that they can be used in combination. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, 1-3, 5-12, 16-20 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species of patentably indistinct species requires a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search quarries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Frank Eisenschenk on 08/17/2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-8, 11. In addition, a species election was made to the laser weld. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4, 9-10, 12-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Status of Claims
Claims 1-20 remain pending in the application, with claims 1-3, 5-8, 11 being examined and claims 4, 9-10, 12-20 being withdrawn pursuant to the election made on 08/17/2026.
Claim Objections
Claim 3 objected to because of the following informalities:
Claim 3 line 9 it is suggested to add a semicolon to the end of this line for consistency as all the previous options end in a semicolon.
Appropriate correction is required.
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.
Claims 1-3, 5-8, 11 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.
Claim 1 recites “a cup side wall” on line 5 where it is unclear if this cup side wall is the same or different from the cup side wall described on line 4.
For examination, it will be interpreted that they are the same cup side wall.
Lines 5-6 recites “a pump housing side wall” where it is unclear if this pump housing side wall is the same or different from the pump housing side wall described on lines 4-5.
For examination, it will be interpreted that they are the same pump housing side wall.
It is suggested to amend lines 5-6 to recite “and [[a]] the cup side wall is attached to and directly contacts [[a]] the pump housing side wall”
Claims 2-3, 5-8, 11 are rejected by virtue of being dependent on a rejected claim.
Claim 5 recites “the pump housing” on lines 1-2, where there is insufficient antecedent basis for this limitation, as even though a pump housing side wall has been previously described an actual pump housing has not been described.
Because the cavity is described “for housing a pump”, for examination it will be interpreted that the cavity is the pump housing.
Claim 6 is rejected by virtue of being dependent on a rejected claim.
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.
Claim(s) 1-3, 5, 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shigesada (US-2007/0017914-A1).
Regarding claim 1, Shigesada teaches a lateral flow device pump housing comprising:
a base (cap 20) comprising a cavity (opening 21b) ([0029], [0030], Figure 1); and
a cup (barrel 10) nested inside the cavity (21b), wherein a cup side wall is attached to a pump housing side wall in the base and a cup side wall is attached to and directly contacts a pump housing side wall in the cavity (21b), the cup side wall being attached to said pump housing side wall within the cavity (21b) by laser weld ([0031] see inner diameter of fit-in portion 22 of the cap 20 is formed into a diameter enabled to fit the diameter of the top end 13 of barrel 10, [0013] see it is also enabled to fix the cap and the barrel by laser welding on a fit-in face where the outer perimeter face of the barrel and the inner perimeter face of the cap oppose each other).
Please note that because the cavity houses the pump, the pump housing side wall is a side wall of the cavity.
The limitation “for housing a pump, the pump comprising a compressed absorbent pad in contact with an end of a wicking pad” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Shigesada and the apparatus of Shigesada is capable of housing a pump. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Shigesada (see MPEP §2114).
Please note that the pump (compressed absorbent pad) nor the wicking pad have been positively recited in the claim, and therefore are not a part of the claimed housing.
In Figure 1 of Shigesada described above, the porous membrane will be placed within the opening 21b (cavity) of the cap 20 (base).
Regarding claim 2, Shigesada teaches the housing of claim 1. Shigesada further teaches wherein the cup (10) exerts a pressure on the pump ([0034] see sandwiching face 24 is a face for sandwiching the porous membrane between itself and an opening edge 14 corresponding to an end edge of the opening 11a of the barrel 10, Figures 1, 3).
Please note that the pump has not been positively recited in the claim, and is therefore not a part of the claimed housing.
Regarding claim 3, Shigesada teaches the housing of claim 2. Shigesada further teaches wherein the pressure is:
a) at least about 1000 Newtons per square meter;
Please see [0078] which describes an example of the present invention where the diameter of the barrel is 7 mm, where based on Figure 1 and 4 and [0037], the porous membrane will have substantially the same size.
Additionally, as described in [0080] it describes the different pressing forces (N) when assembling the devices and subsequently welding them together.
Therefore, the area of the porous membrane will be:
Diameter - 7 mm = 0.007 m, converting to meters is done for ease of calculations later
A=πr2 = 3.8x10-5 m2
Taking the lowest pressing force from the experiment: 50 N
Therefore, the pressure will be 50/3.8x10-5 = 1.3x106 N/m2
Please note that the pump has not been positively recited in the claim, and is therefore not a part of the claimed housing.
Regarding claim 5, Shigesada teaches the housing of claim 1. Shiegesada further teaches wherein a bottom surface of the pump housing comprises a rib (radial ribs 25) ([0033], Figure 3).
Regarding claim 6, Shigesada teaches the housing of claim 5. Shiegesada further teaches wherein the rib (25) is parallel to the longest dimension of the bottom surface of the pump housing ([0033] describes the radial ribs 25, where the longest dimension of the bottom surface of the cap 20 is the diameter. Therefore the radial ribs will be parallel to respective diameters).
Regarding claim 7, Shigesada teaches the housing of claim 1. Shiegesada further teaches wherein the cup (10) comprises a length and a width substantially the same as a respective length and width of the pump ([0037] see the porous membrane has a diameter that approximately matches the inner diameter of the cap 20 and the outer diameter of the top end 13 of barrel 10).
Please note that the pump has not been positively recited, and is therefore not a part of the claimed housing.
Regarding claim 8, Shigesada teaches the housing of claim 1. Shigesada further teaches wherein the cup (10) and the base (20) are formed from at least one plastic selected from the group consisting of polystyrene ([0036]).
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.
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) 1-3, 5-8 is/are alternatively rejected and claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mendel-Hartwig (AU-1565501-A), herein Mendel, in view of Noda (WO-9738298-A1) and translated Gerlach (EP-1404447-B1).
Regarding claim 1, if it is determined that the pump is a part of the lateral flow device pump housing:
Mendel teaches a lateral flow device pump housing comprising:
a base (lower housing part 2) comprising a cavity for housing a pump, the pump comprising a compressed absorbent pad (buffer pad 12) in contact with an end of a wicking pad (test strip 6) (page 4 lines 8-10, page 4 lines 25-32, page 5 lines 9-15 where when film 5 is removed it places the buffer pad 12 and membrane strip 6 in contact with each other, Figures 4-5 where the test strip 6 and buffer pad 12 will be within a cavity of the lower housing part 2); and
a cup (recess 15) nested inside the cavity (page 5 lines 14-16, Figure 4 see where at least part of the recess 15 will be nested within the lower housing part 2),
Further, note that because the cavity houses the pump, the pump housing side wall is a side wall of the cavity.
Figure 4 shows that part of the recess 15’s side wall will be in contact with the lower housing part 2 (because the lower housing part 2 holds the buffer pad 12 and test strip 6 it will be a pump housing with side walls).
However, Mendel does not teach specifically that the cup side wall being attached to said pump housing side wall within the cavity by laser weld.
In the same problem solving area of casings for a test strip for conducting an immunoassay, Noda teaches the casing can be made from one or more parts, and that when made from more than one part the parts can be attached together via laser welding (Noda; page 6 lines 7-10, 24-25, page 18 lines 5-10).
It would have been obvious to one skilled in the art to modify the device of Mendel such that the upper housing part and lower housing part are attached together via laser welding as taught by Noda because it is taught by Gerlach that laser welding is a liquid-tight connection (Gerlach; [0027]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., attaching the upper and lower housings by laser welding), and that in combination, each element merely would have performed the same function as it did separately (i.e., the device of Mendel will function the same regardless of how the upper and lower housings are attached), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the upper and lower housing connection of reference Mendel with laser welding of reference Noda, since the result would have been predictable.
Please see Figure 4 of Mendel where the upper housing 1 and lower housing 2 will now be laser welded together, where more specifically, the portion of the recess 15 that contacts the lower housing 2 will now be laser welded together. This is a cup side wall and a pump housing side wall respectively.
Regarding claim 2, modified Mendel teaches the housing of claim 1. Mendel further teaches wherein the cup exerts a pressure on the pump (Mendel; page 5 lines 14-16 see the recess 15 for the buffer pad 12 designed to press the pad against the pull-out film 5, and thereby against the membrane strip 6 when the pull-out film 5 is removed).
Please note that the limitations of claim 2 are directed to the function of the apparatus and/or the manner of operating the apparatus (see MPEP §2114).
Regarding claim 3, modified Mendel teaches the housing of claim 2.
The limitations of claim 3 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Mendel and the apparatus of modified Mendel is capable of exerting a pressure of: at least 1000 Newtons per square meter, between about 1000 Newtons per square meter and about 11,000 Newtons per square meter, between about 1800 Newtons per square meter and about 5000 Newtons per square meter, between about 2200 Newtons per square meter and about 4400 Newtons per square meter, about 1800 Newtons per square meter, about 2200 Newtons per square meter, or about 4400 Newtons per square meter. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Mendel (see MPEP §2114).
Regarding claim 5, modified Mendel teaches the housing of claim 1. Mendel further teaches wherein a bottom surface of the pump housing comprises a rib (Mendel; page 4 lines 8-13 see the lower housing part 2 has mounted a test strip 6, where the test strip 6 is mounted on a ridge (dashed line, which is best seen in Figure 3) in the housing part bottom and the ridge being narrower than the width of the strip).
Regarding claim 6, modified Mendel teaches the housing of claim 5. Mendel further teaches wherein the rib is parallel to the longest dimension of the bottom surface of the cup and/or the pump housing (Mendel; see Figure 3 where the dashed line indicates the ridge where the ridge is parallel to the longest dimension of the lower housing part 2. Additionally, in Figure 3 the buffer pad 12 can be seen, where the buffer pad 12 is within recess 15 and therefore the ridge will also be parallel to the longest dimension of the recess 15).
Regarding claim 7, Mendel teaches the housing of claim 1. Mendel further teaches wherein the cup comprises a length and a width substantially the same as a respective length and width of the pump (Mendel; Figures 3-5 where it is seen that the buffer pad 12 fits within the recess 15, and thus the recess will have a length and width substantially the same as the length and width of the buffer pad).
Regarding claim 8, modified Mendel teaches the housing of claim 1. Mendel further teaches wherein the cup and the base are formed from at least one plastic selected from the group consisting of polypropylene, polystyrene (Mendel; page 4 lines 3-5).
Regarding claim 11, modified Mendel teaches a lateral flow device comprising the housing of claim 1 (please see claim 1 supra, and Mendel page 3 lines 1-2 which describes the flow matrix is plate or sheet shaped such as a membrane strip which allows lateral liquid flow therethrough).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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