DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on May 29, 2026. Claims 1-17 and 24-28 are currently pending.
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 without traverse of Group I in the reply filed on May 29, 2026 is acknowledged.
Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 29, 2026. Claims 18-23 have also been cancelled in response to the Restriction Requirement.
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 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 5 and 28 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.
Concerning claim 5, line 1 of the claim recites the limitation of “the inflatable balloon”. There is a lack of antecedent basis for this limitation in the claim. The limitation of “the inflatable balloon” is instead present in claim 4, therein making the dependency of the claim indefinite. For the purposes of compact prosecution, claim 5 will be interpreted as being dependent on claim 4.
Concerning claim 28, line 7 of the claim recites the limitation of “the inflatable balloon”. There is a lack of antecedent basis for this limitation in the claims. For the purposes of compact prosecution, line 7 of the claim will be interpreted as beginning with the limitation “wherein the flexible catheter includes an inflatable balloon”.
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.
Claim(s) 1-4, 6-9, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sporri et al. (US 2005/0240211, hereinafter Sporri).
Concerning claim 1, the Sporri et al. prior art reference teaches a trans-cervical delivery system (Figures 7A-12), comprising: at least one port (Figure 7A; ports connecting syringes 92, 94, 96 to lines 82, 87, 88); a tubular shaft coupled to the port (Figure 7A; 15), the tubular shaft including at least one hollow channel traversing an interior length of the tubular shaft ([¶ 0082]); and an agent delivery end coupled to the tubular shaft (Figure 7A; distal end portion of 15), the agent delivery end including at least one flexible catheter (Figure 7A; 87, 88) with a plug (Figure 7A; 80, 85).
Concerning claim 2, the Sporri reference teaches the system of claim 1, further comprising a movable sheath surrounding the tubular shaft and the agent delivery end (Figure 7A; 90 | [¶ 0081]).
Concerning claim 3, the Sporri reference teaches the system of claim 1, wherein an advancement of the tubular shaft releases the agent delivery end from the movable sheath ([¶ 0081]).
Concerning claim 4, the Sporri reference teaches the system of claim 1, wherein the plug includes an inflatable balloon located at a distal tip of the flexible catheter (Figure 7A; 80).
Concerning claim 6, the Sporri reference teaches the system of claim 1, wherein a lumen of the flexible catheter may include a wire frame ([¶ 0092]).
Concerning claim 7, the Sporri reference teaches the system of claim 6, wherein the frame is composed of a flexible alloy material ([¶ 0092], wire frame may be a nitinol wire, therein defining a flexible alloy material).
Concerning claim 8, the Sporri reference teaches the system of claim 1, wherein the agent delivery end includes a second flexible catheter with a second plug, and wherein the second plug includes a second inflatable balloon located at a distal tip of the second flexible catheter (Figure 7A; 87, 85).
Concerning claim 9, the Sporri reference teaches the system of claim 1, wherein a fluid or foam agent is capable of being injected through the port and directly administered to a fallopian tube via the agent delivery end ([¶ 0076]).
Concerning claim 24, the Sporri reference teaches the system of claim 1, wherein the at least one flexible catheter is configured to self-expand to enable positioning the at least one flexible catheter in a desired location ([¶ 0092]).
Claim(s) 1, 4-5, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer et al. (US 5,389,089, hereinafter Bauer).
Concerning claims 1, 4-5, and 28, the Bauer et al. prior art reference teaches a trans-cervical delivery system (Figures 1; 11), comprising: at least one port (Figure 1; 37); a tubular shaft coupled to the port (Figure 1; 13), the tubular shaft including at least one hollow channel traversing an interior length of the tubular shaft (Figure 2; 71); and an agent delivery end coupled to the tubular shaft (Figure 2; 29), the agent delivery end including at least one flexible catheter (Figure 4; 43) with a plug (Figure 5; 45), wherein the plug includes an inflatable balloon located at a distal tip of the flexible catheter, wherein the inflatable balloon is inverted at its distal end and affixed to the flexible catheter such that, after inflation, the inflated balloon invaginates the distal tip of the flexible catheter (Figure 5; 45 | Column 4, Lines 42-63).
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.
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sporri et al. (US 2005/0240211, hereinafter Sporri) in view of Begg et al. (US 2020/0289799, hereinafter Begg).
Concerning claims 25-27, the Sporri reference teaches the system of claim 1, wherein the at least one flexible catheter includes a nitinol wire frame and is configured to self-expand to enable positioning the at least one flexible catheter in a desired location ([¶ 0092]), and wherein the at least one flexible catheter is configured for delivery of an agent therethrough ([¶ 0072-0073]), but does not specifically teach a nitinol tube.
However, the Begg reference teaches a trans-cervical delivery system similar to the Sporri reference, wherein the Begg reference further teaches at least one port (Figure 1; 28); a tubular shaft coupled to the port (Figure 1; 30) and an agent delivery end coupled to the tubular shaft, the agent delivery end including at least one flexible catheter (Figure 1; 34) with a plug (Figure 1; 40), wherein the at least one flexible catheter comprises a shape memory tube configured for delivery of an agent therethrough and configured to self-expand to enable positioning the nitinol tube in a desired position ([¶ 0022]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the at least flexible catheter of the Sporri reference comprise a nitinol tube as opposed to a nitinol wire frame given the Begg reference teaches that this is an alternative shape memory structure for forming a flexible catheter configured to self-expand to enable positioning in a desired position (Begg; [¶ 0022]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Lee-Sepsick et al. reference (US 2024/0335618) teaches a trans-cervical delivery system including a port, a shaft, an agent delivery end, and a flexible catheter having a plug; the Buster et al. reference (US 2014/0378752) teaches a trans-cervical delivery system including a port, a shaft, an agent delivery end, and a flexible catheter having a plug, the flexible catheter comprising a nitinol frame; the Blaisdell reference (US 6,080,129) teaches a trans-cervical delivery system including a port, a shaft, an agent delivery end, and a flexible catheter having a plug and a retractable sheath; and the Bacich et al. reference (US 5,376,084) teaches a trans-cervical delivery system including a port, a shaft, an agent delivery end, and a flexible catheter having a plug, the plug being an everting balloon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 6/23/2026
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