Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
This is in response to the non-provisional application filed 07/23/2024.
Claim Interpretation - 35 USC § 112(f)
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 87, 89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 9,107,796 (Foresell)
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 87 of the application recites the step “of inserting an apparatus for treating a sexual dysfunctional female patient comprising at least one expandable prosthesis adapted for implantation in female erectile tissue” which corresponds to Foresell ’796, claim 3 step “placing an at least one expandable prosthesis …”.
Claim 89 recites the step “creating an opening in the skin … e. dissecting … and f. placing at least one expandable prosthesis” which corresponds to Foresell ’796, claim 1 step “a) creating an opening … b) dissecting …, and c) placing …”.
It is clear that all the elements of claims 87, 89 are to be found in claim 3 of the patent. The difference between claims 87, 89 of the application and claim 3 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim 3 of the patent is in effect a “species” of the “generic” invention of claims 87, 89 of the current application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 87-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,484,464 (Foresell)
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 87 of the application recites the step “of inserting an apparatus for treating a sexual dysfunctional female patient comprising at least one expandable prosthesis adapted for implantation in female erectile tissue” which corresponds to Foresell ’464, claim 1 step “placing the at least one expandable prosthesis within said area, adapted to postoperatively erect said female erectile tissue on patient command”.
Claim 88 recites the step “of postoperatively controlling the apparatus” which corresponds to Foresell ’464, claim 2 step “controlling said at least one prosthesis postoperatively and non-invasively from outside the body.”
Claim 89 recites the step “creating an opening in the skin … e. dissecting … and f. placing at least one expandable prosthesis” which corresponds to Foresell ’464, claim 1 step “creating an opening in the skin or vaginal wall of the female patient; dissecting at least one area of the female erectile tissue; placing the at least one expandable prosthesis”.
Claim 90 recites the step “controlling said at least one prosthesis postoperatively …” which corresponds to Foresell ’464, claim 2 “step “controlling said at least one prosthesis postoperatively and non-invasively from outside the body.”
Claim 91 recites the step “placing a power source within the body.…” which corresponds to Foresell ’464, claim 3 step “placing a power source within the body.”
Claim 92 recites the step “placing a pump and a reservoir.…” which corresponds to Foresell ’464, claim 4 step “placing a pump and a reservoir ...”
Claim 93 recites the step “placing a control unit and a rechargeable battery remote.…” which corresponds to Foresell ’796, claim 5 step “placing a control unit and a rechargeable battery remote.”
Claim 94 recites the step “placing hydraulic conduits …” which corresponds to Foresell ’464, claim 6 step “placing hydraulic conduits ...”
It is clear that all the elements of claims 87-94 are to be found in claims 1-6 of the patent. The difference between claims 87-94 of the application and claims 1-6 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim 1-6 of the patent is in effect a “species” of the “generic” invention of claims 87-94 of the current application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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 87-94 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 87 recites a method for treating a female sexually dysfunctional patient comprising the step of inserting an apparatus, which renders the claim unclear. It is the position of the Office that is unclear because the claim does not specify where the apparatus is inserted and thus the claim (on its face) is unclear how treating a female sexually dysfunctional patient can be accomplished when there are no steps actively associated with a female sexually dysfunctional patient. The Office suggests amending claim 87 in the following manner to withdraw the rejection:
Claim 87: “…comprising: inserting the apparatus into the patient’s [specified anatomical site]; positioning at least one expandable prosthesis within the female erectile tissue; and adjusting the prosthesis to temporarily enlarge the female erectile tissue.”
Claim 89 recites the step of placing at least one expandable prosthesis within said area. It is the position of the Office that this renders claim indefinite as it repeats exact limitation recited in claim 87. Thus it is unclear if the applicant is intending to refer back to the previously recited at least one expandable prosthesis or claim an entirely new one.
The Office suggests defining “apparatus” and “area” with antecedent basis (e.g., “the apparatus,” “the area” previously defined by a dissecting or visualization step), specify insertion site and method action steps that relate to the patient (e.g., “into the patient’s body via [transvaginal/transperitoneal] approach”), and avoid repeated identical steps across dependent claims unless they introduce a meaningful limitation.
The office suggests the following amendment to withdraw the rejection:
Claim 89: “…wherein ‘placing’ comprises positioning the previously recited expandable prosthesis within the dissected erectile tissue area and securing it via [anchors/sutures/adhesive], the prosthesis being adjustable to achieve temporary enlargement.”
Claim Objections
Claims 97-103 are objected to because of the following informalities: Regarding claim 97, “filling the body through the tube or needle” should specify “patient’s body” and the target cavity (e.g., “insufflating the pelvic cavity with gas…”), if that is the intended technique.
Additionally, the reference to “patients body” in line 7 of claim 95 should be “patient’s body”.
Appropriate correction is required.
Prior Art
A search was conducted and the closest art does not anticipate or render obvious the allowed claims. Accordingly, there are no prior art rejection of the claims.
As a reminder, a terminal disclaimer alone would not be a complete reply to this action. You must also request reconsideration and address the 112(b) issues with specific amendments.
Allowable Subject Matter
Claims 95-103 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: claim 95 recites an operation method using an apparatus for treating a sexual dysfunctional female patient comprising at least one expandable prosthesis adapted for implantation in female erectile tissue and adapted to be adjusted to temporarily achieve enlarged status of the female erectile tissue, comprising the steps of: inserting a tube or needle into the patient’s body, filling the body through the tube or needle with a gas and thereby expanding a cavity within the female patients body, inserting at least two key hole surgery trocars into said cavity, inserting at least one camera through at least one trocar, inserting at least one dissecting tool through at least one trocar, dissecting the area of the erectile tissue placing at least one expandable prosthesis within said area, adapted to postoperatively erect said female erectile tissue on patient command.
In particular, the two-trocar keyhole approach combined with intra-cavity camera guidance and placement of an adjustable prosthesis adapted to postoperatively erect female erectile tissue on patient command is not taught or suggested by the art of record.
The Office agrees the art of record fail to teach or suggest these features.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771