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 .
Claim Objections
Claim 1 is objected to because of the following informalities: The term “comprises” on line 7 has been misspelled as “comrpises” Appropriate correction is required.
Claims 7-9 are objected to because of the following informalities: The weight unit “g” should be inserted after the number “9.5” in claim 7, the volume unit “cm3” should be inserted after the number “7.0” in claim 8, and the area unit “cm2” should be inserted after the number “75” in claim 9 to match the formatting used in claims 3-6. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: The term “the” should be inserted before each occurrence of the phrase “active agent” on line 3 since an “active agent” has been introduced in claim 1. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: The term “an” in the phrase “an active agent” on line 3 should be replaced with the term “the” since an “active agent” has been introduced in claim 1. The term “the” should be inserted before each of the phrases “first wing” and “second” wing” on line 4 in order to be grammatically correct. The term “or” on line 4 should be replaced with the term “and” in order to be grammatically correct. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The term “the” in phrase “the thickness” on line 2 should be replaced with the term “a” since this is the first time that a “thickness” is being introduced. The term “planar” should be inserted before the term “flap” on line 2 to match the language used in claim 1. 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 19 and 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.
Claim 19 recites the phrase “may be” on line 3, rendering the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. For the sake of examination, the limitation following the phrase is interpreted as being part of the claimed invention. Accordingly, it is suggested to amend claim 19 by replacing the phrase “may be” with the term “is”.
Claim 20 recites “spine” on line 2. Since this term lacks an article preceding it, it is unclear if claim 20 intended to introduce “a spine” or refer to the “spine” of claim 19. For the sake of examination, the latter is the interpretation applied to the claim. Accordingly, it is suggested to amend claim 20 to recite dependence on claim 19 (instead of claim 1) and to insert the term “the” before the term “spine” on line 2.
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 1-6, 9, 10, 14, 15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rathbone et al. (PG PUB 2002/0026158).
Re claim 1, Rathbone discloses a device (as seen in Fig 3; described in Para 22-34) for insertion into a cavity (“vaginal insertion”, Para 27), the device comprising: a body (“resilient spine”, Para 32) for insertion into the cavity, the body comprising a variable geometry retention mechanism (as seen in Fig 3A, the body is T-shaped; Para 32); and one or more matrices impregnated with an active agent (“matrix of progesterone containing silicone rubber material”, Para 24), the one or more matrices over-moulding at least a portion of the body (Para 32), the one or more matrices extending from the body to form a planar flap (two planar flaps are labeled in Fig A below), wherein the one or more matrices comprises a ratio of exposed surface area to weight of 11:1 to 17:1 (Para 28 discloses that the exposed surface area of the one or more matrices is 100-150 cm2, Para 29 discloses that the weight percent of progesterone in the one or more matrices is 10%, and Para 25 discloses that the amount of progesterone is 1-1.5 g; therefore, this means that the weight of the one or more matrices is 10-15 g, resulting in a ratio that ranges from 6.67:1 (when the total weight in 15 g and the surface area is 100 cm2) to 15:1 (when the total weight is 10 g and the surface area is 150 cm2).
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Re claim 2, Rathbone discloses that the device is an intra-vaginal device (Para 22).
Re claim 3, Rathbone discloses that the exposed surface area of the one or more matrices is at about 145 to 155 cm2 (Para 28).
Re claim 4, Rathbone discloses that the volume of the one or more matrices is about 12.0 cm3 to 13.5 cm3 (Para 28 discloses a surface area of 100 cm3 to 150 cm3 and Para 26 discloses that the thickness of the matrix is 1 mm (0.1 cm), resulting in the matrix having a volume of approximately 10 cm3 to 15 cm3).
Re claim 5, Rathbone discloses that the weight of the one or more matrices is about 12.0 g to 14.0 g (Para 29 discloses that the progesterone is 10% of the weight of the matrix and Para 25 discloses that the progesterone is 1-1.5 g, resulting in the matrix having a weight of 10-15 g).
Re claim 6, Rathbone discloses that the device contains about 0.5 g to 1.5 g of the active agent (Para 25).
Re claim 9, Rathbone discloses that the body has a surface area of about 75 to 95 cm2 (since Para 28 discloses that the surface area of the matrix is 100 to 150 cm2, Para 26 discloses that the thickness of the matrix is 1 mm (0.1 cm), and Para 30 discloses that the matrix encloses the body).
Re claim 10, Rathbone discloses that the device maintains a plasma concentration of at least 2 ng/mL (Para 27).
Re claim 14, Rathbone discloses that the one or more matrices extends from at least two or more sides of the body (as seen in Fig 3E-3I).
Re claim 15, Rathbone discloses that the one or more matrices extend laterally from the body (as seen in Fig 3E-3I).
Re claim 17, Rathbone discloses that at least a portion of a perimeter of the body is of a substantially flat and elongate form comprising a wave-like configuration (it is noted that the term “substantially” does not require a surface that is exactly flat and the phrase “wave-like” has not been described in the specification as referring to a specific geometry shape; therefore, the phrase is interpreted as reading on any configuration that rises and falls; the portion of the body surrounding line H-H in Fig 3A is both substantially flat (as seen in Fig 3H) and is curved (so it rises and falls) since it is the hinged part (Para 76)).
Re claim 18, Rathbone discloses that the ratio of the exposed surface area to the volume of the one or more matrices provides both a) a pre-determined release rate of the active agent (Para 27), and b) a minimization of a residual amount of the active agent within the one or more matrices (Para 27).
Re claim 19, Rathbone discloses that the body comprises a spine (“resilient spine”, Para 32) and the variable geometry retention mechanism comprises a first wing and a second wing (“in the form of a ‘T’ with the arms of the ‘T’”, Para 32; wherein each arm of the “T” shape is a “wing”) and wherein the one or more matrices impregnated with the active agent is over-moulded on any one or more of the spine, the first wing and the second wing (Para 32).
Re claim 20, Rathbone discloses that the one or more matrices is free of having the body or spine within the thickness of the flap (as seen in Fig 3E).
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rathbone et al. (PG PUB 2002/0026158).
Re claim 7, Rathbone does not explicitly disclose that the body has a weight of 9.5 to 13.5 g. However, it would have been an obvious matter of design choice to include the body with a weight of 9.5 to 13.5 g since Applicant has not disclosed that providing the body with such a weight solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this weight, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Re claim 8, Rathbone does not explicitly disclose that the body has a volume of 7.0 to 12.0 cm3. However, it would have been an obvious matter of design choice to include the body with a volume of 7.0 to 12.0 cm3 since Applicant has not disclosed that providing the body with such a volume solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this volume, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Response to Arguments and Declaration
Applicant’s arguments and the declaration filed 4/6/2026 have been considered.
The arguments directed to the previously-utilized Simpson reference are moot in view of the present rejections that no longer utilize Simpson.
The argument that “the claimed geometry yields unexpected functional benefits” based on the declaration is not persuasive because the declaration pertains to the geometry of the matrix, not the weight of the body. Therefore, the declaration does not establish that the claimed weight of the body yields unexpected functional benefits. Since claim 8 has been rejected as design choice in the present application, the Examiner notes that the declaration does not establish that the volume of the body yields unexpected functional benefits.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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