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 Objections
Claim 1 is objected to because of the following informalities:
“Device for” should be “A device for”
Claims 2-19 are objected to because of the following informalities:
“Device according to” should be “The device according to”
Claim 20 is objected to because of the following informalities:
“System for” should be “A system for”
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.
Claim 6 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.
Claim 6 recites the limitation “the same average angle” in line 5 of the claim. There is insufficient basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited element.
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 1-2, 5-7, 14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cattanach (US 4848363 A) in view of Hall (US 4496355 A).
With respect to claim 1, Cattanach discloses a device for collecting fluid loss (see Fig. 1, #1) including:
a tubular body (see Fig. 1-2 and col 3 lines 34-58, receptable #2 having a body #3 defining a collection chamber #4 and a rim #5) having a first open free end (see Fig. 1-2 and col 3 lines 34-58, inlet opening #6) and a second end (see Fig. 1-2 and col 3 lines 34-58, chamber having a downstream outlet region), the tubular body including at least: -
flared section, and including the first open free end, the flared section having an increasing diameter from the conduit to the first open free end (see Fig. 1-2 and col 3 lines 34-58, the rim #5 and inlet opening #6 may have a length of between 100-150mm and may taper from a diameter of between 50-100 mm adjacent to rim to terminal end #10 which forms a flared collection mouth wider than the downstream body), and a part, referred to as top part, of the first open free end being more radially spaced relative to the conduit than another part, referred to as bottom part, of the first open free end, which is diametrically opposite the top part (see Fig. 1-2 and col 4 lines 6-13: rim opening extends in a plane that is acutely angled relative to the receptable body so that in device use the rim upstands the receptacle body with the upwardly facing opening extending about the cervix and the receptable body extending down the body part where the acute angle places the top of the rim at a greater radial offset from the body/outlet axis than the diametrically opposite bottom).
Cattanach does not specifically disclose a conduit, including a second open free end with the flared section extending from the conduit.
Hall teaches a tubular body with a conduit, including a second open free end (see Fig. 1 and Fig. 5, receptable #12 has a hollow stem #14 interpreted to be the conduit which is connected by a union #60 to tubing #62 leading to a fluid reservoir #64) with a flared section extending from the conduit (see Fig. 5: #46 extends from #12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach with the teachings of Hall to have included a conduit because it would have resulted in the predictable result of draining fluid that is collected into a receptable into a drainage bag (Hall: see col 7 lines 1-16) for storage or analysis.
With respect to claim 2, all limitations of claim 1 apply in which Cattanach further discloses that the flared section includes a first side, referred to as top side, which includes the top part of the first open free end (see Fig. 1, top side is the part that upstands about the cervix) , a second side, referred to as bottom side, which includes the bottom part of the first open free end (see Fig. 1, bottom side is the part that lies along the body extending down), and in that the top side of the flared section is flared relative to the conduit according to an average angle (a) greater than the bottom side of the flared section (see Fig.1: top side is flared at a greater average angle than the bottom side).
With respect to claim 5, all limitations of claim 2 apply in which Cattanach further discloses that the top side of the flared section has a substantially "S"-shaped profile (see Fig. 2).
With respect to claim 6, all limitations of claim 1 apply in which Cattanach further discloses that the flared section includes a lateral side, referred to as left lateral side, and another lateral side, referred to a right lateral side, which is diametrically opposite the left lateral side, and in that the left lateral side and the right lateral side are flared relative to the conduit according to the same average angle (see Fig. 1: the receptable has two sides as it is symmetrical about its median plane).
With respect to claim 7, all limitations of claim 1 apply in which Cattanach further discloses that a geometric centre of the first open free end is off-centred relative to a geometric centre of the conduit (30) (see Fig. 1: the acute rim angle offsets the inlet opening center from the body axis).
With respect to claim 14, all limitations of claim 1 apply in which Hall further teaches in that the conduit includes a connection endpiece configured to connect a quantification receptacle thereto (see Fig. 1 and Fig. 5, receptable #12 has a hollow stem #14 interpreted to be the conduit which is connected by a union #60 interpreted to be the connection endpiece to tubing #62 leading to a fluid reservoir #64 interpreted to be the quantification receptacle).
With respect to claim 17, all limitations of claim 1 apply in which Cattanach further discloses that the flared section is configured to be inserted into a postpartum patient's vagina, for example in the vicinity of the outer orifice of the cervix (see Fig. 5, inserted into patient’s vagina).
With respect to claim 18, all limitations of claim 17 apply in which the combination of Cattanach and Hall further teaches that it is configured to form a vaginal device for collecting blood loss (Hall: see Fig. 5; intended use, device can collect blood).
With respect to claim 19, all limitations of claim 17 apply in which Cattanach further discloses that the top part is configured to be positioned in the patient's vagina towards the bladder whereas the bottom part is configured to be positioned towards the rectum (see Figs. 5-7).
With respect to claim 20, Cattanach and Hall further teaches a system for quantifying fluid loss including a device for collecting fluid loss according to claim 1 (Hall: see Fig. 1, device 1; and see claim 1 above), and a quantification receptacle (Hall: see Fig. 5, #64) , ready to be connected to the conduit of the device (Hall: see Fig. 5: #64 connects to #14 of device #1).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cattanach in view of Hall as applied to claim 2 above, and further in view of Ratcliffe (US 3776235 A).
With respect to claim 3, all limitations of claim 2 apply in which Cattanach and Hall do not specifically teach that the bottom side of the flared section has a substantially straight profile.
Ratcliffe teaches a receptacle with a flared section that has a substantially straight profile on the bottom side (see Fig. 4, hollow chamber #13 has flared section at end with straight profile on bottom side).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach and Hall with the teachings of Ratcliffe to have a straight profile at the bottom side of a flared section because it would have resulted in the predictable result of having a chamber that continues in line with a drain tube to be in proper pressure position for patient (Ratcliffe: see col 2 lines 57-66).
With respect to claim 4, all limitations of claim 2 apply in which Cattanach and Hall do not specifically teach that the bottom side of the flared section is aligned relative to the conduit.
Ratcliffe teaches a receptacle with a flared section that has a conduit that is aligned relative to it (see Fig. 4, hollow chamber #13 has flared section at end aligned to drain tube #14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach and Hall with the teachings of Ratcliffe to have aligned flared section with a conduit because it would have resulted in the predictable result of having a chamber that continues in line with a drain tube to be in proper pressure position for patient (Ratcliffe: see col 2 lines 57-66).
Claims 8-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cattanach in view of Hall as applied to claim 1 above, and further in view of Zoller (US 3845766 A).
With respect to claim 8, all limitations of claim 1 apply in which Cattanach and Hall do not further teach that it includes an insertion holding system.
Zoller teaches an insertion holding system (see Fig. 1: annular ribs #4-#7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach and Hall with the teachings of Zoller to have included an inserting holding system because it would have resulted in the predictable result of holding a device in place in the vaginal canal (Zoller: see col 3 lines 9-31).
With respect to claim 9, all limitations of claim 8 apply in which Zoller further teaches that the insertion holding system includes a bead formed at the outer periphery of the first open free end (see Fig. 1, outwardly folded edge/flange around annular ribs #5-#7).
With respect to claim 15, all limitations of claim 1 apply in which Cattanach and Hall do not further teach that the flared section is made of a biocompatible material.
Zoller teaches that the flared section is made of a biocompatible material (see col 3 lines 9-15: cup shaped body is made of soft elastomeric material such as natural rubber with is biocompatible).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach and Hall with the teachings of Zoller to have utilized a biocompatible material because it would have resulted in the predictable result of using a material that does not irritate the body and also as a desired degree of imperviousness to liquid and can be easily cleaned (Zoller: see col 3 lines 9-31).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Cattanach in view of Hall as applied to claim 1 above, and further in view of Bletzinger (US 3068867 A).
With respect to claim 10, all limitations of claim 1 apply in which Cattanach and Hall do not specifically disclose that it includes a positioning indicator.
Bletzinger teaches a positioning indicator (see col 2 lines 57-64: positioning indicator as a touch sensitive indicator).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach and Hall with the teachings of Bletzinger to have a positioning indicator because it would have resulted in the predictable result of providing correcting insertion positioning (Bletzinger: see col 2 lines 19-25).
Claims 11-13 is rejected under 35 U.S.C. 103 as being unpatentable over Cattanach in view of Hall and Bletzinger as applied to claim 10 above, and further in view of Fung (US 20090247930 A1).
With respect to claim 11, all limitations of claim 10 apply in which Cattanach, Hall and Bletzinger do not specifically teach that the positioning indicator includes a rib which extends longitudinally along a part of a top side of the device.
Fung teaches a positioning indicator that includes a rib which extends longitudinally along a part of a top side of the device (see paragraph 0029: barrel has ribs that keep plunger aligned during withdrawal and ejection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach, Hall and Bletzinger with the teachings of Fung to have included ribs because it would have resulted in the predictable result of facilitating smooth insertion of a intravaginal device (Fung: see [0029]).
With respect to claim 12, all limitations of claim 11 apply in which Fung further teaches that the rib is configured to rigidify the collection device in flexion (see paragraph 0029).
With respect to claim 13, all limitations of claim 11 apply in which Fung further teaches that the rib extends longitudinally along at least a part of the top side of the conduit, or also along a part of the top side of the flared section (see paragraph 0029 and Fig. 1A-1B).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cattanach in view of Hall and Zoller as applied to claim 15 above, and further in view of Booher (US 8550088 A).
With respect to claim 16, all limitations of claim 15 apply in which Cattanach, Hall and Zoller do not specifically teach that the material has a hardness between 40 shore A and 80 shore A.
Booher teaches that elastomeric materials including silicone based materials utilized for vaginal tissues are materials that fall between hardness range of 20-50 durometer on the Shore scale (see col 6 lines 20-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cattanach, Hall and Zoller with the teachings of Booher to have utilized a material with a specific hardness as it is known that suitable elastomeric materials for devices for vagina have a hardness of between 20-50 durometer on the Shore A scale (Booher: see col 6 lines 20-37).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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