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
Applicant's election with traverse of Species b) figures 14-19, claims 38, 50, 52, and 71-89 in the reply filed on 03/02/2026 is acknowledged. The traversal is on the ground(s) the statement that “no claim is generic” and at least claim 50 reads in all three identified species. The examiner agrees. Claim 50 is generic.
With respect to that there is no showing of a burden for search for the intrauterine treatment devices since they are in the same field. This is not found fully persuasive because the reasons for insisting upon election of one species are the facts relied upon for the conclusion that there are claims restricted respectively to two or more patentably different species that are disclosed in the application. The breath of a single disclosed species does not necessitate the examination of the other disclosed species and their concomitant features. The examination of other species would include a determination of the patentability of the species additional features in combination with the subcombination common to all species, which determination amounts to an examination of multiple inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-12, 14-25, 36, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/02/2026. Please note claim 53 has been withdrawn from consideration by the examiner as being drawn to the non-elected species a) and c).
Drawings
The drawings are objected to because the second lumen surrounds the first lumen set forth in claim 86 incorporating the limitations of claims 50, 84, and 85.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
In [00043] line 1 refers to figure 6. There is no figure 6, but figures 6A-6B.
In [00046], line 1 refers to figure 16. There is no figure 16, but figures 16A-16C.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 86 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 86 is indefinite and confusing. It depends from claims 85, 84, and 50 were already has been established that the first and second lumen are inside the shaft. Claim 86 set forth that the second lumen surrounds the first lumen. This does not make sense. It is reversing the lumens once they are defined in claim 85. This appears to be a different embodiment from previously presented in the order of claims. Please clarify.
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 38, 50, 52, 77, 79, 80-81, 84-85, and 87-88 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desai (WO 2004035110 A2).
Regarding claim 38, Desai discloses a method of treating abnormal uterine bleeding (page 1, Field of Invention), comprising the steps of:
1) providing a device (figs 19a-19c) comprising:
a) a shaft 204 having a proximal end and a distal end; and
b) a lumen (figs 19a, 19c) enclosed within the shaft having a port 214 at the proximal end for introducing a treatment fluid, and an opening at the distal end (figs 19a,19c) for dispensing the treatment fluid;
2) providing a source of treatment fluid 216 comprising a sclerotherapeutic agent (claim 4) to said port;
3) inserting the distal end of the device into the external cervical os (fig 19a) of a subject suffering from abnormal uterine bleeding, wherein the abnormal uterine bleeding is characterized by one or more bleeding blood vessels at or near a site of bleeding; and
4) introducing the treatment fluid via the port (page 23, lines 25-27)), through the lumen, out the distal shaft opening and into the uterus, at a pressure effective to provide retrograde flow of the treatment fluid into the one or more bleeding blood vessels.
Regarding claim 50, Desai discloses a device for treating abnormal uterine bleeding (figs 19a-19c), comprising:
a) a shaft 204 having a proximal end and a distal end; and
b) a first lumen (figs 19a, 19c) enclosed within the shaft having a first port 214 at the proximal end and a first valve 215 operable to open or close the lumen, for introducing a treatment fluid, and an opening at the distal end for dispensing the treatment fluid.
Regarding claim 52, Desai discloses a method of treating abnormal uterine bleeding (page 1, Field of Invention; figs 19a-19c), comprising the steps of:
1) inserting the distal end of the device of claim 50 into the external cervical os of a subject suffering from abnormal uterine bleeding, wherein the abnormal uterine bleeding is characterized by one or more bleeding blood vessels at or near a site of bleeding;
2) providing a source of treatment fluid 216 comprising a sclerotherapeutic agent (claim 4) to said first port; and
3) introducing the treatment fluid via the first port (page 23, lines 25-27), through the first lumen, out the distal shaft opening and into the uterus, at a pressure effective to provide retrograde flow of the treatment fluid into the one or more bleeding blood vessels.
Regarding claim 77, Desai discloses wherein the sclerotherapeutic agent is a vascular sclerosing agent (claim 4).
Regarding claim 79, Desai discloses wherein the source of treatment fluid further comprises a reservoir 216 (syringe).
Regarding claim 80, Desai discloses wherein the reservoir is integral to the device, or connected to it prior to dispensing the treatment fluid (figure 19a; at 216; page 23).
Regarding claim 81, Desai further discloses comprising administering a second therapeutic (neutral gel substance to rinse the uterus, page 25).
Regarding claim 84, Desai discloses wherein the shaft contains a second lumen within the shaft (see figure 20).
Regarding claim 85, Desai discloses wherein the second lumen is parallel to the first lumen (see figure 20).
Regarding claim 87, Desai discloses further comprising a source of treatment fluid 216 comprising a sclerotherapeutic agent (claim 4), that provides the treatment fluid to said first port.
Regarding claim 88, Desai discloses wherein the sclerotherapeutic agent is a vascular sclerosing agent (claim 4).
Claims 38, 71, 72, 76-77, 79-81, 83-85, and 87-88 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shikhman et al. (US 20200261707 A1).
Regarding claim 38, Shikhman discloses a method of treating abnormal uterine bleeding [0081], comprising the steps of:
1) providing a device (figs 1-5, 14a-15) comprising:
a) a shaft 54 having a proximal end and a distal end; and
b) a lumen (fig 3) enclosed within the shaft having a port (17b, figure 15) at the proximal end for introducing a treatment fluid, and an opening at the distal end (fig 3) for dispensing the treatment fluid;
2) providing a source of treatment fluid 130 comprising a sclerotherapeutic agent [0088] to said port;
3) inserting the distal end of the device into the external cervical os (figs 1-2, 14a-15) of a subject suffering from abnormal uterine bleeding, wherein the abnormal uterine bleeding is characterized by one or more bleeding blood vessels at or near a site of bleeding; and
4) introducing the treatment fluid via the port 17b, through the lumen, out the distal shaft opening and into the uterus, at a pressure effective to provide retrograde flow of the treatment fluid into the one or more bleeding blood vessels.
Regarding claim 71, Shikhman discloses further comprising inflating a balloon 11 disposed at the distal end of the device.
Regarding claim 72, Shikhman discloses wherein the source of the treatment fluid is an injection means 130 wherein the injection means comprises a syringe.
Regarding claim 76, Shikhman discloses wherein the lumen contains a valve 160 operable to open or close the lumen [0125, 0130].
Regarding claim 77, Shikhman discloses wherein the serotherapeutic agent is a vascular sclerosing agent [0088].
Regarding claim 79, Shikhman discloses wherein the source of treatment fluid
further comprises a reservoir 130 ((syringe); see figure 17, container 172).
Regarding claim 80, Shikhman discloses wherein the reservoir is connected to
it prior to dispensing the treatment fluid (figure 15).
Regarding claim 81, Shikhman Desai further discloses comprising
administering a second therapeutic ([0088], saline).
Regarding claim 83, Shikhman further comprising: an inflatable balloon 11 disposed at a distal end of the shaft (fig 14b); a balloon inflating lumen 128 (that goes into device) for introducing a fluid into the inflatable balloon; a second lumen within the shaft, having a second port at the proximal end and a second opening at the distal end for drainage 126 [0117]] (fig 14b).
Regarding claim 84, Shikhman discloses wherein the shaft contains a second lumen within the shaft (see figure 21).
Regarding claim 85, Shikhman discloses wherein the second lumen is parallel to the first lumen (see figure 21).
Regarding claim 87, Shikhman discloses further comprising a source of treatment fluid 130 comprising a sclerotherapeutic agent, that provides the treatment fluid to said first port.
Regarding claim 88, Shikhman discloses wherein the sclerotherapeutic agent is a vascular sclerosing agent [0088].
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.
Claims 74 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Desai (WO 2004035110 A2).
Desai discloses on page 27, lines 9-21, that pressure monitor 312 monitors intrauterine pressure. However, Desai fails to disclose the intrauterine pressure of about 10 to about 100 mm Hg is maintained, or the intrauterine pressure of at least about 30 mm Hg is maintained.
This parameter (pressure) is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Desai’s pressure with the claimed parameters since they are obvious to one of skill in the art to prevent damage in the intrauterine cavity.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Desai (WO 2004035110 A2) in view of Carson et al (US 20170224379 A1).
As best understood by examiner in view of 112b rejection above.
Desai discloses in figure 19B discloses a multiple lumen catheter 206 parallel to each other, but does not show specifically the second lumen surrounding the first lumen. (see 112b rejection above).
Carson teaches in figure 21 a second lumen 23 surrounding the first lumen 34. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Desai’s multi lumen catheter by rearranging the lumens as desired since this modification is obvious design choice, and taught by Carson. Lumens arrangement modification is well known in the art of catheters for its intended purpose.
Claims 78 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Desai (WO 2004035110 A2) in view of Levy et al (US 11690988 B2).
Desai discloses a vascular sclerotherapeutic agent (in claim 4), but fails to disclose specifically polidocanol.
Levy teaches in [0007] the use of polidocanol for vascular sclerotherapy in the Summary of the invention to treat vascular issues relating to vein ablation. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Desai’s vascular sclerotherapeutic agent by including Levy’s polidocanol for bleeding treatment, since it well known in the art for treating vascular system as a sclerosing agent.
Allowable Subject Matter
Claims 73 and 82 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights