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 without traverse of claims 1-20 in the reply filed on 01/06/2026 is acknowledged.
No Claims have been withdrawn from further consideration pursuant to 37 CFR 1.142(b). Election was made without traverse in the reply filed on 01/06/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 4-6, 8-9,14 and 16 are objected to because of the following informalities: “…base body…” should read “…closed base body…”. 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.
Claims 1-20 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.
The term “substantially egg-shaped opening” in line 6 of claim 1is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, as the specification did not provide guidelines for the term “substantially” in the claim used in conjunction with another term to describe a particular characteristic of the claimed invention.
Claim 1 recites the limitation "the height" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially trapezoidal opening” in line 8 claim 1is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, as the specification did not provide guidelines for the term “substantially” in the claim used in conjunction with another term to describe a particular characteristic of the claimed invention.
The claim limitation “…preferably…” in line 8 of claim 1 render the claim indefinite as it creates uncertainty as to which features are claimed as mandatory and which features are merely optional.
The term “substantially elliptical shape” in line 10 claim 1is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, as the specification did not provide guidelines for the term “substantially” in the claim used in conjunction with another term to describe a particular characteristic of the claimed invention.
The term “substantially convexly curved” in lines 2-3 claim 1is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, as the specification did not provide guidelines for the term “substantially” in the claim used in conjunction with another term to describe a particular characteristic of the claimed invention.
Claim 2 recites the limitation "the side of the opening" and “the cross-sectional view” in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially differently convexly curved” in lines 4-5 claim 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, as the specification did not provide guidelines for the term “substantially” in the claim used in conjunction with another term to describe a particular characteristic of the claimed invention.
As to claim 5, it is unclear to the Office how “…the height of the base body changes continually in the circumferential direction…”. Clarification is requested.
Claim 6 recites the limitation "the outside of the base body" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The use of the term "pocket-like deepening" in line 1 of claim 6 does not positively recite the "pocket" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting "pocket-shaped deepening" in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim 7 recites the limitation "the side of the central opening" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the side of the central opening" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the receiving volume" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the side of the opening" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially uniformly convexly curved” in line 2 claim 12 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, as the specification did not provide guidelines for the term “substantially” in the claim used in conjunction with another term to describe a particular characteristic of the claimed invention.
Claim 13 recites the limitation "the opening" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the opening" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the thickness of the side wall sections" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the direction" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
As to claim 17, the limitation “…wherein at least one deepening…” renders the claim indefinite as claim 6 from which claim 17 depends recite “a pocket-like deepening” which is implied to be a single deepening as best understood from the claim.
The claim limitation “…preferably…” in line 2 of claim 17 render the claim indefinite as it creates uncertainty as to which features are claimed as mandatory and which features are merely optional.
Claims 3-4, 9, 11, 15-16 and 18-20 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 since they depend directly or indirectly on rejected base claim 1 and therefore, contain the same deficiencies.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 6-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitation, “…wherein the base body, in at least one side wall section, has a pocket-like deepening opened on the outside of the base body in order to form a suction or adhesion zone for adjacent tissue in an insertion state of the vaginal pessary” positively recites part of the human body.
To obviate a rejection under 35 USC 101, the Office suggests that any claim that would include a human being, or part thereof, within its scope should use “configured to” or configured for” to define the metes and bounds of the claimed subject matter which is a permissible form of expression; as for example, “…wherein the base body, in at least one side wall section, has a pocket-like deepening opened on the outside of the base body in order to form a suction or adhesion zone configured for adjacent tissue in an insertion state of the vaginal pessary”.
Claims 7-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism since they depend directly on rejected claim 6 and therefore contain the same deficiencies.
Claim Rejections - 35 USC § 102
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 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 and 12 (as best understood, see rejection to 112(b) above are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spitz et al. U.S. Publication No. (2010/0305395 A1).
With respect to claim 1, Spitz et al. discloses a vaginal pessary [0015] and (fig.7) comprising: a circumferentially closed base body (32, fig.7), wherein the base body has two side wall sections, a front, anterior wall section and a rear, posterior wall section, and wherein a central opening of the base body in a cross-sectional view transversely to the height of the base body is delimited by a closed, inner contour line of the wall sections (as shown in the reproduced image of fig.7 below); wherein the inner contour line of the wall sections has a substantially egg-shaped opening which deviates from the circular shape (as shown in the reproduced image of fig.7 below).
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With respect to claim 4, Spitz et al. discloses the base body is formed by wall sections which merge into one another all the way round (as shown in the reproduced image of fig.7) above.
With respect to claim 12, Spitz et al. discloses the side wall sections are substantially uniformly convexly curved on the side of the opening (as shown in the reproduced image of fig.7 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786