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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim1,4,7-12 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 12, the claim reads “comprising a vinyl alcohol polymer having a degree of hydrolysis from 98-99%.” The examiner notes that this subject matter was referenced in the arguments (Filed 10/22) to be cited in pages 6-7. The examiner notes that in pages 6-7 the citations merely indicated physical properties of materials used “The physical characteristics of the product depend on the degree of polymerization and the amount of hydrolysis” (page 6) and “The solubility of vinyl alcohol polymers depends largely on their amount of hydrolysis. A polymer with a level of hydrolysis between 85 to 89% dissolves easily at room temperature, while PVA that has high hydrolysis degree (98-99%) is not soluble at room temperature. This difference in solubility is due to the hydrogen bonds between the vinyl alcohol chains which are greater when the degree of hydrolysis is high” (page 7). The examiner notes that although this indicates that some PVA have hydrolysis degrees between 98-99%, there is no support for the invention of the instant application using this material. Rather the only indication of the hydrolysis degree of the material used for the device is in page 3, where “In a preferred embodiment the water soluble mouldable material has a degree of hydrolysis from 85-89%” which is no longer claimed. Therefore claims 1 and 12 are rejected under 35 U.S.C 112a. Claims 4,7-11 are rejected based on dependency.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,4,7-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the.
Claim Objections
Claim 1 objected to because of the following informalities: claim 1 requires "the opening and closing mechanism…urges the closure against the outlet opening”, which is interpreted as a method of operation of the device. The claim should read “configured to urge”. Appropriate correction is required.
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 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.
Claim 1 (and 4,12 by dependency) require an opening-and-closing mechanism. Such a mechanism is not defined in the specification. The examiner notes that as based understood based on the specification and claims the mechanism (defined as 9,11 in claim 1) comprises an arm (9 per claim 7) connected to a resilient member (11 per claim 8). Therefore it is interpreted that any opening/closing mechanism comprising a resilient member and an arm, reads to the claimed 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.
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) 1,3,5,7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harboe WO 96/41653 in view of Mao US 5688459, where Harboe was provided in the IDS, and Mao was provided in the previous office action.
Regarding Claim 1, Harboe discloses
A one-piece integrally moulded female urine drainage device (Fig. 1-10): a tubular part (Fig. 1 tubular part (1)) having a distal end (3, document page 5 line 21-22) and a proximal end (2, the examiner notes that while (2) is directed to the inlet holes, the end at which said holes are located at is disclosed to be the proximal end document page 5 line 16); an inlet opening (Fig. 1, openings (2)) at the proximal end; an outlet opening (Fig. 1, outlet opening (3)) at the distal end; a hand grip (Fig. 1 , grip 10, seen used by the hand in figure 10) projecting from the tubular part (Fig. 1); a closure (Fig. 1, closure (4)) for closing the outlet opening (document page 5 line 23- document page 6 line 32); a first hinge (Fig 3. Hinge (5), document page 5 line 24-25) connecting the closure to the tubular part.
Harboe further discloses (per amendments filed 10/22) and opening and closing mechanism (see arm (6), deformable handle (8) and hinge connecting the two (7)) connected between the closure (4) and the hand grip (10) and which, in a stable configuration, urges the closure against the outlet opening (see figures 3,4, 8-11, document page 6, lines 25-32).
While Harboe teaches that the device is desired to be biodegradable (document page 3, lines 26-27), Harboe fails to teach that the device is formed of specifically a water soluble mouldable material.
Mao teaches a medical catheter (urinary per abstract) and is thus considered analogous to the claimed invention. Mao teaches that the device uses Polyvinyl alcohol (PVA) with a random copolymer of vinyl acetate (column 2, lines 63-67 and column 3, lines 1-6). Mao further teaches that the PVA has a desired degree of hydrolysis of above 95 mol%, preferably 99.5% (column 2 lines 63-67 and column 3, lines 1-6). The examiner notes that the range of 95-99.5% overlaps with the claimed range of 98-99%. Therefore, as Mao teaches that PVA is known to be used for urinary catheters where the degree of hydrolysis is desirable to be between 95-99.5%, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, as a matter of simple substitution, to use PVA with a hydrolysis degree of 98-99% as the material of Harboe, to perform the same function as the structure of the PVA structure per the rejection of claim 1, being water soluble, as Mao teaches that such material is used for urinary catheters.
Regarding Claim 7, Harboe and Mao teach
A female urine drainage device according to claim 1 in which the opening and closing mechanism (Harboe (per claim 1, combination of 6,7,8)) comprises an extension arm (Harboe Fig. 1-4, part (6))) on the closure (4). See page 8, lines 15-32 of Harboe.
Regarding Claim 8, Harboe and Mao teach
The female urine drainage device according to claim 7 in which the extension arm (Harboe Fig. 1-4, part (6)) is connected to a resilient member (Harboe Fig 1, operation handle (8), seen changing positions in figures 3 and 4 and 10-11). See page 8, lines 15-32 of Harboe.
Regarding Claim 9, Harboe and Mao teach
The female urine drainage device according to claim 8 in which the extension arm (Harboe Fig. 1, (6)) is connected to the resilient member (Harboe Fig. 1 (8)) by a second hinge (Harboe Fig. 1-4, second hinge (7)). See page 8, lines 15-32 of Harboe.
Regarding Claim 10, Harboe and Mao teach
The female urine drainage device according to claim 8 in which the resilient member (Harboe Fig. 1, (8)) is connected to a projection ((Harboe Fig. 1-4, projecting grip (10)) on the tubular part (Harboe Fig. 1, (1)). See page 8, lines 15-32 of Harboe.
Regarding Claim 11, Harboe and Mao teach
A female urine drainage device according to claim 10 in which the resilient member (Harboe Fig. 1, (8)) is connected to the projection ((Harboe Fig. 1-4, projecting grip (10)) on the tubular part (Harboe Fig. 1, (1)) by a third hinge (Harboe Fig. 1-4, third hinge (9)). See claim 1 of Harboe.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harboe in view of Mao, as evidenced by StackExchange Chemistry “What will be the name of CH2=CH-O-CO-CH3?” 12/01/2019 https://chemistry.stackexchange.com/questions/124485/what-will-be-the-name-of-ch2-ch-o-co-ch3.
Regarding Claim 4, Harboe and Mao teach
A female urine drainage device according to claim 1 in which the water soluble mouldable material has the chemical formula [CH2CH(OR)]n where R = H or COCH3, with the COCH3 groups being randomly distributed throughout the molecule. The examiner notes that as detailed under the rejection of claim 1, PVA is used for the material, known to have a formula of CH2CHOH (per the Millipore reference previously provided), and thus reads to the claimed limitation.
Should applicant assert that the claim also requires COCH3, despite the use of or, the examiner again cites Mao.
As detailed under the rejection of claim 1, Mao teaches a medical catheter (urinary per abstract) and is thus considered analogous to the claimed invention. Mao teaches that the device uses Polyvinyl alcohol with a random copolymer of vinyl acetate (column 2, lines 63-67 and column 3, lines 1-6). The examiner notes that vinyl acetate, known to have a formula of CH2CHOCOCH3, as evidence by the StackExchange evidentiary reference. Therefore, as Mao teaches that PVA used for urinary catheters may comprise random copolymers of CH2CHOCOCH3, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, as a matter of simple substitution, to use the PVA comprising said vinyl acetate to perform the same function as the structure of the PVA structure per the rejection of claim 1, being water soluble, as Mao teaches that use of said material for urinary catheters.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harboe in view of Mao, and further in view of Smith GB 2528466, provided in the IDS and previous office action.
Regarding Claim 12, Harboe discloses
A method of using a female urine drainage device (figure 10,11 of Harboe): the device comprising a tubular part (Fig. 1 tubular part (1)) having a distal end (3, document page 5 line 21-22) and a proximal end (2, the examiner notes that while (2) is directed to the inlet holes, the end at which said holes are located at is disclosed to be the proximal end document page 5 line 16); an inlet opening (Fig. 1, openings (2)) at the proximal end; an outlet opening (Fig. 1, outlet opening (3)) at the distal end; a hand grip (Fig. 1 , grip 10, seen used by the hand in figure 10) projecting from the tubular part (Fig. 1); a closure (Fig. 1, closure (4)) for closing the outlet opening (document page 5 line 23- document page 6 line 32); a first hinge (Fig 3. Hinge (5), document page 5 line 24-25) connecting the closure to the tubular part, and opening and closing mechanism (see arm (6), deformable handle (8) and hinge connecting the two (7)) connected between the closure (4) and the hand grip (10) and which, in a stable configuration, urges the closure against the outlet opening (see figures 3,4, 8-11, document page 6, lines 25-32).
While Harboe teaches that the device is desired to be biodegradable (document page 3, lines 26-27), Harboe fails to teach that the device is formed of specifically a water soluble mouldable material.
Mao teaches a medical catheter (urinary per abstract) and is thus considered analogous to the claimed invention. Mao teaches that the device uses Polyvinyl alcohol (PVA) with a random copolymer of vinyl acetate (column 2, lines 63-67 and column 3, lines 1-6). Mao further teaches that the PVA has a desired degree of hydrolysis of above 95 mol%, preferably 99.5% (column 2 lines 63-67 and column 3, lines 1-6). The examiner notes that the range of 95-99.5% overlaps with the claimed range of 98-99%. Therefore, as Mao teaches that PVA is known to be used for urinary catheters where the degree of hydrolysis is desirable to be between 95-99.5%, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, as a matter of simple substitution, to use PVA with a hydrolysis degree of 98-99% as the material of Harboe, to perform the same function as the structure of the PVA structure per the rejection of claim 1, being water soluble, as Mao teaches that such material is used for urinary catheters.
The examiner notes that the device of Harboe and Mao the device is made from water soluble materials and disposable. However, there is no clear teaching that the device is flushed after use.
Smith teaches a urinary catheter and is thus considered analogous to the claimed invention. Smith teaches that the device is configured to be flushable such to allow for convenient and hygienic disposal after use (document page 3, lines 8-11), while still maintaining their intended shape during use due to the material polyvinyl alcohol (PVA) being used for the body (document page 1, line 1-16). Smith also teaches that the device is degradable (document page 5, line 25-26) and further biodegradable (document page 8 line 21-22). Therefore, as Harboe and Mao teaches PVA as a material of a urinary catheter, and Smith teaches catheters made from PVA allow for more convenient and hygienic dispose of used catheters (via flushing) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention flush the PVA catheter of Harboe and Mao, as taught by Smith.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/
Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781