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 .
Response to Amendment
The amendment filed 1/16/2024 has been entered: Claims 1-6 remain pending in the present application. Claims 1-4 are currently amended and claims 5-6 are new. Claims 1-6 are examined on the merits.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 3 recites “the said body”. This should be corrected to only recite only one of “the” or “said”.
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 1-6 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 “glass-shaped” in claim 1 is not defined in the claims or specification and it is unclear what features or elements would be essential for an object to be “glass-shaped”. Additionally, it is unclear what the distinction is between a “glass-shaped” or ““cup”” body. Thus, the metes and bounds of the claim cannot be determined. In an effort to promote compact prosecution, the term “glass-shaped” is interpreted as comprising an side-walls, a bottom wall, and an open top.
Claim 1 also recites a ““cup” body”. While the term “cup” would be understood by one of ordinary skill in the art, it is unclear how Applicant intends to modify the term by placing the term in quotations. The specification and claims do not further define the term. Additionally, it is unclear what the distinction is between a “glass-shaped” or ““cup”” body. In an effort to promote compact prosecution, the term “glass-shaped” is interpreted as comprising an side-walls, a bottom wall, and an open top.
The term “threadlike” in claim 1 is a relative term which renders the claim indefinite. The term “threadlike” 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. It is unclear what features of thread are required by the term for an element to be sufficiently “threadlike”. In an effort to promote compact prosecution, and extended projection is interpreted to be equivalent to the threadlike end.
Claims 2-5 are rejected via their dependency on claim one.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Conti (US 2022/0370772 A1), in view of Rusch et al. (US 6,359,191 B1).
Regarding claim 1, Conti discloses a menstrual cup with a vaginally release product (Figs. 10 and 12A-C; Abstract), comprising:
a glass-shaped or “cup” body (device 200 and body 202) having a threadlike end (end 204),
a vaginally release product (¶s 6, 69, 138, and 185) incorporated on at least an external surface of the said body (¶ 138 describes how the ridges 148, which are incorporated on an external surface of the body, are permeable for medication delivery; ¶ 162 also describes how external indicators strips may be used and that medication may be used in one or all of said sections; ¶s 185 and 197 describes medication or other compositions being incorporated as a surface coating).
Conti does not explicitly teach the vaginal release product is impregnated in a strip made of 100% soluble material, the strip adhere about on the actual surface of the body of the cup.
However, Rusch teaches a drug delivering vaginal tampon (Figs. 1, 4, 12, and 13; Abstract), thus being in the same field of endeavor, comprising a vaginal release product impregnated in a strip (Fig. 13 shows dissolvable capsules 32; Col. 5, lines 35-42 and lines 57-67) adhered to an outer surface of the device (Col. 5, lines 17-19) made of 100% soluble material (gelatin is known to be soluble; the Abstract also indicates the layers are at least partially dissolved which would encompass up to 100% soluble).
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 the vaginal release product of Conti to be explicitly impregnated in a strip made of 100% soluble material, as taught by Rusch. Doing so would thus comprise a strip adherable on the external surface of the body of the cup. Doing so would be advantageous in ensuring contact of the vaginal release compound with the mucous membranes of the vagina (Col. 5, lines 61-67 of Rusch).
Further, the limitations of the external surface being “adapted to retain the vaginally release product in contact with a vaginally wall when the cup is in contact with the vaginally wall” and the strip being “incurable on the external surface of the body of the cup” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Conti and Rusch has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to retain the vaginally release product in contact with the vaginally wall; see ¶ 185 and 212 of Conti which describes the dissolving and absorption mechanism and the medication being adhered to the external surface of the cup).
Regarding claim 2, Conti further teaches the external surface of the body of the cup possesses a band having a slight offset, (ridge 248) and having a smooth surface (¶ 185 indicates the embodiments may comprise a smooth outer surface).
The combination does not explicitly disclose the band thickness being “of the thickness of the strip disclosed”.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Conti and Rusch to have the offset being of the thickness of the strip disclosed since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Conti and Rusch would not operate differently with the claimed thickness. Further, applicant places no criticality on the dimensions claimed (¶ 29 indicates the thickness is merely preferable).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Conti and Rusch as applied to claim 1 above, and further in view of Simmons et al. (US 2023/0390343 A1).
Regarding claim 3, the combination of Conti and Rusch substantially disclose the invention of claim 1. The combination does not explicitly disclose the vaginal release product is a dilutable agent or agents that help to maintain pH balance of the vaginal wall.
Simmons teaches a vaginal release product for use during the menstrual cycle (Abstract; ¶s 13 and 19 indicate menstrual application), thus being in the same field of endeavor, which is configured to help maintain pH balance of the vaginal wall (¶ 111 indicates the objective of the composition is to maintain a pH of the vagina; ¶ 112 indicates the compound is intended to be absorbed by vaginal mucosal tissue, i.e. is dilutable therein).
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 the vaginal release product of Conti and Rusch to explicitly comprise the dilutable agent to help maintain pH balance of the vaginal wall, as taught by Simmons. Doing so would be advantageous in preventing urogenital disorders (¶ 20 of Simmons; also see ¶ 80).
Regarding claim 4, the combination of Conti and Rusch substantially disclose the invention of claim 1. The combination does not explicitly disclose the vaginal release product is a probiotic agent.
Simmons teaches a vaginal release product for use during the menstrual cycle (Abstract; ¶s 13 and 19 indicate menstrual application), thus being in the same field of endeavor, which is a probiotic agent (¶s 79-80 and 111).
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 the vaginal release product of Conti and Rusch to explicitly comprise the release product as a probiotic agent as taught by Simmons. Doing so would be advantageous in preventing urogenital disorders (¶ 20 of Simmons).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Conti and Rusch as applied to claim 2 above, and further in view of Simmons.
Regarding claim 5, the combination of Conti and Rusch substantially disclose the invention of claim 2. The combination does not explicitly disclose the vaginal release product is a dilutable agent or agents that help to maintain pH balance of the vaginal wall.
Simmons teaches a vaginal release product for use during the menstrual cycle (Abstract; ¶s 13 and 19 indicate menstrual application), thus being in the same field of endeavor, which is configured to help maintain pH balance of the vaginal wall (¶ 111 indicates the objective of the composition is to maintain a pH of the vagina; ¶ 112 indicates the compound is intended to be absorbed by vaginal mucosal tissue, i.e. is dilutable therein).
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 the vaginal release product of Conti and Rusch to explicitly comprise the dilutable agent to help maintain pH balance of the vaginal wall, as taught by Simmons. Doing so would be advantageous in preventing urogenital disorders (¶ 20 of Simmons; also see ¶ 80).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Conti and Rusch as applied to claim 3 above, and further in view of Simmons.
Regarding claim 6, the combination of Conti and Rusch substantially disclose the invention of claim 3. The combination does not explicitly disclose the vaginal release product is a probiotic agent.
Simmons teaches a vaginal release product for use during the menstrual cycle (Abstract; ¶s 13 and 19 indicate menstrual application), thus being in the same field of endeavor, which is a probiotic agent (¶s 79-80 and 111).
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 the vaginal release product of Conti and Rusch to explicitly comprise the release product as a probiotic agent as taught by Simmons. Doing so would be advantageous in preventing urogenital disorders (¶ 20 of Simmons).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781