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
Claims 7 and 16 are objected to because of the following informalities:
Claim 7, line 1: “,” (between “wherein” and “the”) should be removed.
Claim 16, line 1: --is-- should be added after “connector”.
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 claim 1, unidirectional adjustment mechanism in claim 2, adjustment elements in claim 5, support mechanism in claim 5, unidirectional adjustment mechanism in claim 10, support mechanism in claim 11, adjustment elements in claim 11, adjustment elements in claim 13, support mechanism in claim 13, and unidirectional adjustment mechanism in claim 18.
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-18 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-18 of prior U.S. Patent No. 12,137,882. This is a statutory double patenting rejection.
Claim 1 of the patent is identical to claim 1 of the application.
Claim 2 of the patent is identical to claim 2 of the application.
Claim 3 of the patent is identical to claim 3 of the application.
Claim 4 of the patent is identical to claim 4 of the application.
Claim 5 of the patent is identical to claim 5 of the application.
Claim 6 of the patent is identical to claim 6 of the application.
Claim 7 of the patent is identical to claim 7 of the application.
Claim 8 of the patent is identical to claim 8 of the application.
Claim 9 of the patent is identical to claim 9 of the application.
Claim 10 of the patent is identical to claim 10 of the application.
Claim 11 of the patent is identical to claim 11 of the application.
Claim 12 of the patent is identical to claim 12 of the application.
Claim 13 of the patent is identical to claim 13 of the application.
Claim 14 of the patent is identical to claim 14 of the application.
Claim 15 of the patent is identical to claim 15 of the application.
Claim 16 of the patent is identical to claim 16 of the application.
Claim 17 of the patent is identical to claim 17 of the application.
Claim 18 of the patent is identical to claim 18 of the application.
Therefore, claims 1-18 of the patent are coextensive in scope with claims 1-18 of the application.
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 1, 2, 4 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13-15, 17 and 18 of U.S. Patent No. 10,806,339. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of U.S. Patent 10,806,339 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 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 grooves arranged along the longitudinal axis, the tandem comprising a multi-lumen shaft configured to receive an optical fiber therethrough;
an ovoid assembly comprising first and second adjustably inflatable ovoids and an ovoid support mechanism, the ovoid assembly comprising 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 using a unidirectional adjustment mechanism, each of the handles comprising a multi-lumen shaft, the handles adapted to allow for user manipulation to control the relative position of the ovoids for insertion of the ovoids within fornices of a patient, the first and second adjustably inflatable ovoids having a deflated configuration for insertion into a patient and one or more adjustably inflated configurations for positioning the ovoid assembly during treatment, the ovoid support mechanism configured to establish a longitudinal position of the ovoid assembly relative to the tandem based on a coupling of the ovoid support mechanism with the one or more grooves;
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 1 of the application are to be found in claim 1 of the patent. The difference between claim 1 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 1 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 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claims 2 and 4 of the application can be found in lines 15-24 of claim 1 of the patent.
Claim 13 of the patent recites “A brachytherapy applicator 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 comprising a multi-lumen shaft;
an ovoid assembly comprising first and second adjustably inflatable ovoids and an ovoid support mechanism, 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, the first and second adjustably inflatable ovoids having a deflated configuration for insertion into a patient and one or more adjustably inflated configurations for positioning the ovoid assembly during treatment;
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 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 treatment site in a patient.”
It is clear that all the elements of claim 13 of the application are to be found in claim 13 of the patent. The difference between claim 13 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 13 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 13 of the application is anticipated by claim 13 of the patent, it is not patentably distinct from claim 13 of the patent.
Claim 14 of the patent is identical to claim 14 of the application.
Claim 15 of the application can be found in lines 17-21 of claim 13 of the patent.
Claim 17 of the patent is identical to claim 16 of the application.
Claims 17 and 18 of the application can be found in claims 13-15 of the patent.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,617,503. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of U.S. Patent 11,617,503 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 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 grooves arranged along the longitudinal axis, the tandem comprising a multi-lumen shaft comprising an optical fiber;
a camera coupled to the 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, the ovoid assembly comprising 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 and to allow for user manipulation to control the relative position of the ovoids for insertion of the ovoids within fornices of a patient, the first and second adjustably inflatable ovoids having a deflated configuration for insertion into a patient and one or more adjustably inflated configurations for positioning the ovoid assembly during treatment, the ovoid support mechanism configured to establish a longitudinal position of the ovoid assembly relative to the tandem based on a coupling of the ovoid support mechanism with the one or more grooves;
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 1 of the application are to be found in claim 1 of the patent. The difference between claim 1 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 1 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 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claim 2 of the patent is identical to claim 2 of the application.
Claim 3 of the application can be found in claims 1 and 3 of the patent.
Claim 4 of the application can be found in lines 16-22 of claim 1 of the patent.
Claim 5 of U.S. Patent 11,617,503 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 grooves arranged along the longitudinal axis;
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 ovoid assembly comprises first and second handles configured to support the respective first and second inflatable ovoids, wherein the handles are adapted to allow for user manipulation to control a relative position of the ovoids for insertion of the ovoids within fornices of a patient;
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 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 5 of the application are to be found in claim 5 of the patent. The difference between claim 5 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 5 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 5 of the application is anticipated by claim 5 of the patent, it is not patentably distinct from claim 5 of the patent.
Claim 6 of the patent is identical to claim 6 of the application
Claim 7 of the patent is identical to claim 7 of the application.
Claim 8 of the patent is identical to claim 8 of the application.
Claim 9 of the patent is identical to claim 9 of the application.
Claim 10 of the patent is identical to claim 10 of the application.
Claim 11 of the patent is identical to claim 11 of the application.
Claim 12 of the patent is identical to claim 12 of the application.
Claim 13 of U.S. Patent 11,617,503 recites “A brachytherapy applicator 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 comprising a multi-lumen shaft, wherein the tandem comprises an endoscopic viewing element to facilitate positioning of the tandem;
an ovoid assembly comprising first and second adjustably inflatable ovoids and an ovoid support mechanism, 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;
first and second adjustably inflatable retractors adapted to be releasably 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 cervical treatment site in a patient.”
It is clear that all the elements of claim 13 of the application are to be found in claim 13 of the patent. The difference between claim 13 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 13 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 13 of the application is anticipated by claim 13 of the patent, it is not patentably distinct from claim 13 of the patent.
Claim 14 of the patent is identical to claim 14 of the application.
Claim 15 of the patent is identical to claim 15 of the application.
Claim 16 of the patent is identical to claim 16 of the application.
Claim 17 of the patent is identical to claim 17 of the application.
Claim 18 of the patent is identical to claim 18 of the application.
Conclusion
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