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 .
Allowable Subject Matter
The indicated allowability of claims 73 and 82 (now incorporated in claims 95-96) in the previous Office action is withdrawn in view of the newly discovered reference(s) to Yurek et al (2015/0133779). Rejections based on the newly cited reference(s) follow.
Election/Restrictions
Newly submitted claims 38 and 50 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 38 and 50 set forth “a conformable tip disposed proximate the distal end of the shaft”. This feature is not shown on the elected figures 14-19 nor any figures of the application. Additionally, this limitation is not in the original claims, and is mutually exclusive from the elected species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 38, 50,52, 71-72, 74-81, 83-85, and 87-94 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
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 95-96 are rejected under 35 U.S.C. 103 as being unpatentable over Desai (WO 2004035110 A2) in view of Yurek et al (US 20150133779 A1).
Regarding claim 95, Desai discloses a method of treating abnormal uterine bleeding (page 1, Field of Invention), comprising the steps of:
providing a device (figs 19a-19c) comprising:
- a shaft 204 having a proximal end and a distal end;
- a conical tip 222 disposed on the shaft, the conical tip configured to form a seal with the cervical os, and
- 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;
providing a source of treatment fluid 216 comprising a sclerotherapeutic agent (claim 4) to said port;
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
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.
On pages 26 (line 16) – page 27 (line 8), figure 22, Desai also discloses that the plug 306 can be moved or fixed along catheter 300 and cites that this teaching can be incorporated into figures 19a-21. However, Desai fails to disclose specifically the conical tip being a conical gel tip and disposed at the distal end of the shaft, and the conical gel tip configured to form a seal with an external cervical os.
Yurek teaches (in [0068] figures 5 and 11a) an overtube 102 including a conical gel tip (stopper 106) that can be attached to or integrated with the distal terminal end of the overtube 102. The stopper 106 can be configured to seal the cervix 136 around the catheter 8, such as by plugging the external os of the cervix 136. During use, the stopper 106 can be positioned relative to the catheter 8 and longitudinally fixed to the catheter 8 to control the depth of the distal tip 12 in the cervix 136 and uterus 140 to reduce trauma [0018]. 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 shaft/conical tip catheter configuration with the teachings of Desai and Yurek by modifying Desai’s catheter device with Yurek configuration of the conical gel tip and forming a seal with an external cervical os since such modification enhance comfort of the patient and reduce trauma.
Regarding claim 96, Desai discloses a device for treating abnormal uterine bleeding (figs 19a-19c), comprising:
a shaft 204 having a proximal end and a distal end;
a conical tip 222 disposed on the shaft; and
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.
On pages 26 (line 16) – page 27 (line 8), figure 22, Desai also discloses that the plug 306 can be moved or fixed along catheter 300 and cites that this teaching can be incorporated into figures 19a-21. However, Desai fails to disclose specifically the conical tip being a conical gel tip and disposed at the distal end of the shaft, and the conical gel tip configured to form a seal with an external cervical os.
Yurek teaches (in [0068] figures 5 and 11a) and overtube 102 including a conical gel tip (stopper 106) that can be attached to or integrated with the distal terminal end of the overtube 102. The stopper 106 can be configured to seal the cervix 136 around the catheter 8, such as by plugging the external os of the cervix 136. During use, the stopper 106 can be positioned relative to the catheter 8 and longitudinally fixed to the catheter 8 to control the depth of the distal tip 12 in the cervix 136 and uterus 140 to reduce trauma [0018]. 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 shaft/conical tip catheter configuration with the teachings of Desai and Yurek by modifying Desai’s catheter device with Yurek configuration of the conical gel tip and forming a seal with an external cervical os since such modification enhance comfort of the patient and reduce trauma.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection. Claims 38, 50 and their respective dependent claims have been withdrawn. See new grounds of rejection to claims 95-96 above.
The examiner recommends applicant to present arguments based on the actual paragraphs of the original specification and not the paragraphs from the US Publication of the application.
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..
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, 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