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 19 is objected to because of the following informalities:
Claim 19, line 3: --one or more-- should be added between “the” and “adjustment”.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: adjustment elements in claims 19 and 31, adjustment mechanism in claims 20 and 30, and support mechanism in claims 31 and 33.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 31 and 33-38 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 31 recites the limitation "the ovoid support mechanism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the relative position" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19-38 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rahimian, U.S. PG-Pub 2013/0109908.
Regarding claim 19, Rahimian discloses a system for treating cancers with a brachytherapy applicator, comprising: a tandem assembly comprising a tandem (202) and one or more adjustment elements (224, 265, 267); an ovoid assembly comprising first and second inflatable ovoids (212, 214), the one or more adjustment elements configured to allow coupling between the tandem assembly and the ovoid assembly (Figs. 15-16 and paragraphs [0075], [0081], [0082]); and a first inflatable retractor (230) adapted to be coupled to the ovoid assembly; wherein the tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous treatment site in a patient (Fig. 15 and paragraph [0076]).
Regarding claims 20-23, Rahimian further comprises an adjustment mechanism (249) configured to allow modification of an angular position of the first and second inflatable ovoids (212, 214) relative to the tandem assembly (Fig. 15 and paragraph [0079]); wherein the tandem assembly comprises a lumen (bottom lumen of tandem 202) comprising an optical fiber (290) (Fig. 17); further comprises a camera configured to facilitate positioning of the tandem (202) (paragraph [0084]); and wherein the ovoid assembly is configured to support the respective first and second inflatable ovoids to allow for control of a relative position of the ovoids for insertion within fornices of the patient (paragraph [0075]).
Regarding claim 24, Rahimian discloses a system for treating cancers, the system comprising: a tandem assembly comprising a tandem (202) (Fig. 15); a camera coupled to an optical fiber (290) and configured to facilitate positioning of the tandem (Fig. 17 and paragraph [0084]); an ovoid assembly comprising first and second inflatable ovoids (212, 214) and configured to allow adjustable coupling between the tandem assembly and the ovoid assembly (Fig. 16 and paragraphs [0075], [0081], [0082]); wherein the tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous treatment site in a patient (paragraph [0076]).
Regarding claims 25 and 26, Rahimian discloses wherein the first and second inflatable ovoids (212, 214) have a deflated configuration for insertion into a patient and one or more inflated configurations for positioning the ovoid assembly during treatment (Fig. 16 and paragraph [0075]).
Regarding claims 27 and 28, Rahimian discloses wherein a shaft of the tandem (202) comprises at least two lumens (top lumen and bottom lumen in which 290 is inserted) (Fig. 17).
Regarding claims 29-32, Rahimian discloses wherein a shaft of the tandem (202) is configured to link an ultrasound transducer therethrough (Fig. 17 and paragraph [0084]); wherein the ovoid assembly comprises an adjustment mechanism (249) configured to allow modification of an angular position of the first and second inflatable ovoids (212, 214) relative to the tandem assembly (Figs. 16-17 and paragraph [0079]); wherein an ovoid support mechanism (216) is configured to position the ovoid assembly relative to the tandem (202) via one or more adjustment elements (224, 265, 267) (Fig. 16 and paragraph [0075], [0081], [0082]); and wherein the ovoid assembly comprises a multi-lumen shaft (each ovoid 212 and 214 is attached to its own respective lumen shaft) configured to deliver radiation therapy therethrough (Fig. 18 and paragraph [0076]).
Regarding claim 33, Rahimian discloses a brachytherapy applicator comprising: a tandem assembly comprising a tandem and a plurality of adjustment elements (224, 265, 267), the tandem adapted for insertion into a patient; an ovoid assembly comprising first and second ovoids (212, 214) and an ovoid support mechanism (216), the plurality of adjustment elements configured to allow adjustable coupling between the tandem assembly and the ovoid assembly to control a relative position of the ovoids (Figs. 15-16 and paragraphs [0075], [0081], [0082]); wherein the tandem and the first and second adjustable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment in a patient (paragraph [0076]).
Regarding claims 34-38, Rahimian discloses wherein the tandem assembly comprises one or more grooves (252); wherein the first and second adjustable ovoids (212, 214) have a deflated configuration and one or more inflated configurations (Fig. 16 and paragraph [0075]); wherein the tandem assembly is adapted to limit rotational movement of the tandem (202) (paragraph [0081]); and wherein one or more of the tandem assembly and the ovoid assembly comprises a unidirectional, toothed adjustment mechanism (248 and toothed wheel 249) (Fig. 17 and paragraphs [0078], [0079]).
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.
Like elements of the claims will be bolded.
Claims 19-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,137,882. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 19 of the application, claim 1 of the patent recites “A system for treating cervical and/or uterine cancers in brachytherapy with an intracavitary brachytherapy applicator, comprising: a tandem assembly comprising a tandem and a tandem connector, the tandem adapted for insertion into a cervix of a patient along a longitudinal axis, the tandem connector comprising one or more adjustment elements arranged along the longitudinal axis; an ovoid assembly comprising first and second adjustably inflatable ovoids, the adjustment elements configured to allow axially adjustable coupling between the tandem assembly and the ovoid assembly; and a first inflatable retractor adapted to be releasably coupled to the ovoid assembly, the first inflatable retractor having a deflated configuration for insertion into a patient and an adjustably inflated configuration for retraction of tissue during treatment; wherein the tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous cervical and/or uterus treatment site in a patient.”
It is clear that all the elements of claim 19 of the application are to be found in claim 1 of the patent. The difference between claim 19 of the application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claim 19 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 19 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claims 20-23 of the application can be found in claims 2-4 of the patent.
Regarding claim 24 of the application, claim 5 of the patent recites “A system for treating cervical and/or uterine cancers, the system comprising: a tandem assembly comprising a tandem and a tandem connector, the tandem adapted for insertion into a cervix of a patient and the tandem connector adapted to receive the tandem within an interior of the tandem connector along a longitudinal axis, the tandem connector comprising one or more adjustment elements; a camera coupled to an optical fiber and configured to facilitate positioning of the tandem; an ovoid assembly comprising first and second adjustably inflatable ovoids and an ovoid support mechanism, wherein the one or more adjustment elements are configured to allow axially adjustable coupling between the tandem assembly and the ovoid assembly; and first and second adjustably inflatable retractors adapted to be releasably coupled to the ovoid assembly, the first and second inflatable retractors having a deflated configuration for insertion into a patient and an adjustably inflated configuration; wherein the tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous cervical and/or uterus treatment site in a patient.”
It is clear that all the elements of claim 24 of the application are to be found in claim 5 of the patent. The difference between claim 24 of the application and claim 5 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus the invention of claim 5 of the patent is in effect a “species” of the “generic” invention of claim 24 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 24 of the application is anticipated by claim 5 of the patent, it is not patentably distinct from claim 5 of the patent.
Claims 25-32 of the application can be found in claims 6-12 of the patent.
Regarding claim 33 of the application, claim 13 of the patent recites “A brachytherapy applicator comprising: a tandem assembly comprising a tandem and a tandem connector comprising a plurality of adjustment elements, the tandem adapted for insertion into a cervix of a patient and the tandem connector adapted to receive the tandem within an interior of the tandem connector along a longitudinal axis; and an ovoid assembly comprising first and second adjustably inflatable ovoids and an ovoid support mechanism, the plurality of adjustment elements of the tandem connector configured to allow axially adjustable coupling between the tandem assembly and the ovoid assembly, wherein the ovoid assembly comprises first and second handles configured to support the respective first and second inflatable ovoids, wherein the handles are configured to allow for user manipulation to control a relative position of the ovoids, wherein the handles are adapted to allow for user manipulation to control the relative position of the ovoids for insertion of the ovoids within fornices of a patient; wherein the tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous cervical treatment site in a patient.”
It is clear that all the elements of claim 33 of the application are to be found in claim 13 of the patent. The difference between claim 33 of the application and claim 13 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus the invention of claim 13 of the patent is in effect a “species” of the “generic” invention of claim 33 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 33 of the application is anticipated by claim 13 of the patent, it is not patentably distinct from claim 13 of the patent.
Claims 34-38 of the application can be found in claims 14-18 of the patent.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's cancellation of claims 1-18 and addition of new claims 19-38 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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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