DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
This action is Non-Final.
Election/Restrictions
Applicant incorrectly does not elect any group. However, to expedite prosecution such requirement will be overlooked and due to the amendments the requirement is withdrawn.
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 12-18 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 12, applicant’s amendments to circumvent the restriction requirement has introduced indefinite issues into the claims. Claim 12 now depends directly from claim 1. Claim 1 requires three separate structures in a vessel, a movement control device, and a connector device; wherein claim 12 features are all now claimed to be further limiting components of the vessel from claim 1 alone as there is no conjunction that separates clauses all must be considered to be parts of the vessel. This makes the claim unclear whether the separate components of claim 1 are not separate anymore. It is not clear whether the “a movement control device coupled to a first end of the collection assembly” is the same or different from “a movement control device coupled to a connector receiving channel of the first periphery”. It is not clear if the connector is part of the vessel or separate component. In summary, it is unclear how these requirements function with those of claim 1, it appears the same structures may or may not be present and are claimed with different terms but may not be different. As there is a great deal of uncertainty, it would be improper to speculatively apply prior art, MPEP 2173.06 In re Steele. Applicant should amend claims 12-18 to more clearly define the structures intended to be claimed and make sure such terms are not duplicated terms. The issue is further exasperated in the claims which depend from claim 12 as terms are reclaimed which exist in claim 1 already such that it is not clear if these are the same or different or which of the two are being further limited. This includes claim 13 “the movement control device…a first external layer and a second external layer. Claim 14 which is being further limited? Claim 15 which is being further limited? Claim 16, which is being further limited? Claim 17, which is being further limited? The dependent claims are rejected for depending on a rejected claim.
MPEP 2173.06:
Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitts (US 2024/0130887).
Regarding claim 1, Mitts teaches a collection assembly comprising:
a vessel providing a first external layer and a second external layer sealed around a first periphery and a second periphery (see at least Figures 1, 9, 13 element 12; [0037]);
the first periphery is permitted for holding a fluid, the second periphery is permitted to release the fluid (see at least Figures 1, 9, 13 element 12; [0008]);
a movement control device coupled to a connector receiving channel of the first periphery (see at least Figures 1-2, [0031] adapter 24); and
a connector device coupled to the vessel (see at least Figures 1-2, [0029] sampling valve 20, including inlet portion 40).
Regarding claim 2, Mitts teaches wherein the connector device is coupled to the first periphery (see at least Figures 1-2, 4 where 40 is coupled to the first periphery for fluid transfer).
Regarding claim 3, Mitts teaches wherein the vessel further includes an elongated portion in the first periphery (see at least Figures 1-2 where 12 is elongated including the vertical wall of the urine collection bag).
Regarding claim 20, Mitts teaches wherein the collection assembly is particularly suited for urine collection (intended use is met by the claimed structures, see title).
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.
Claims 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mitts (US 2024/0130887) as applied to claim 3 above, and further in view of Kubalak et al. (Kubalak, US 2002/0103460) with evidence from Mitts et al. (Mitts’481, US 7,410,481).
Regarding claim4, the limitations are met by Mitts, except the limitation of wherein the second periphery includes a tear seam is not directly taught.
Kubalak teaches a related system for gathering urine (see title and abstract), and teaches that the bag can include a tear seam to allow for emptying a urine bag as desired (see at least [0051]. [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including a tear seam in a urine collection bag in order to allow for complete emptying of the bag as desired when the bag is no longer in use for quicker samples or dispose of the waste product.
Regarding claim 5, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the vessel further includes a plurality of scale marks for indicating the amount of fluid within the first periphery 9see at least Figure 1 element 82).
Regarding claim 6, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the vessel further includes a pair of passageways positioned on opposing ends of the first periphery (see at least Figures 1-2).
Regarding claim 7, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the movement control device includes a retainer (see at least Figure 3, evidence from Mitts’481 annular ring 48 from Figure 3), a dispenser (see at least Figure 1 element 38) and a cap (interpreted as the flap 22 in the check valve as this functions as a cap to prevent urine backflow into the body when the bag is full).
Regarding claim 8, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the retainer is a ring member (see at least Figure 3, evidence from Mitts’481 annular ring 48 from Figure 3).
Regarding claim 9, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the retainer is positioned within a housing (see at least Figure 3, and evidence from Mitts’481 annular ring 48 from Figure 3 is within housing or collar 26).
the limitations are met by Mitts in view of Kubalak, where Mitts teaches
Regarding claim 10, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the connector device includes a pair of fins extending outwards from a body assembly of the connector device (interpreted to read on elements 52 and 54 of Figures 4-6 as these appear as fins from the cross section and extend outward from 48).
Regarding claim 11, the limitations are met by Mitts in view of Kubalak, where Mitts teaches wherein the connector device includes an end connector coupling to a connector tubing and coupling to the body assembly (see at least Figure 4 element 44 and or 42 with element 40 in connection in the valve).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mitts (US 2024/0130887) as applied to claim 1 above, and further in view of Glithero et al. (Glithero, US 11,738,171).
Regarding claim 19, Mitts teaches a collection assembly made in accordance with claim 1 (see rejection of claim 1), but fails to teach an intermittent tray having:
a first slot, the first slot extends almost an entire length of the intermittent tray;
a second slot, the second slot is positioned adjacent the first slot; and the collection assembly made in accordance with claim 1 nestled within the first slot.
Glithero teaches a related system to be used with catheterization (see title and abstract), and teaches a urine bag placed in an intermittent tray with the particular design configurations as claimed (see at least Figures 31a-b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of coupling a known tray design with a known urine bag design in order to form a kit for medical usage of the bag with other supplies required by medical personnel for application and use.
Conclusion
No prior art rejections have been applied to claims 12-18 due to the indefinite issues raised above as there is a great deal of uncertainty, it would be improper to speculatively apply prior art, MPEP 2173.06, In re Steele.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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