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 .
Drawings
The drawings filed 11/27/2024 are objected to for the following reasons:
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the rotational alignment feature and complementary alignment feature as claimed in claim 7 must be shown or the features canceled from the claims. Neither feature is clearly shown or labeled in any of the figures.
Each of the views in Fig. 19-22 show multiple views of different components of the device but each view does not have its own figure number. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because "[t]he different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter". See MPEP 608.02.
Fig. 6-10 of the application use solid black shading. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because solid black shading areas are not permitted, except when used to represent bar graphs or color. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
“rotational alignment feature” in claim 7, which has been interpreted based on the Specification as a projection or recess (see [0017]) or any structural equivalent thereof.
“ligation band engagement structure” in claims 10 and 20 which has been interpreted based on the Specification as a ramp (see [0016]) or any structural equivalent thereof.
“engagement structure” in claim 12 which has been interpreted based on the Specification as a projection (see [0019]) or any structural equivalent thereof.
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 7-9 and 12-14 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.
In claim 7, the limitation “complementary alignment feature” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The complementary alignment feature is mentioned only once in the written description (see [0017]) and within the same paragraph “the alignment feature” is further defined as “a keyway such as a radially inwardly extending projection or a radially outwardly extending recess”. However, the description makes clear that the referenced alignment feature is the rotational alignment feature which is formed in the base. Applicant has not made clear the corresponding structure, material or act for performing the claimed function of “complementary alignment”.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 8 and 9 both recite the limitation “the alignment feature” in line 1 which renders the scope of the claims indefinite since it is unclear which alignment feature (i.e., the rotational or complementary alignment feature previously recited in claim 7) the limitation refers to. For examination purposes, “the alignment feature” in both claims has been interpreted as “the rotational alignment feature”.
It is further unclear in claims 8 and 9 how an alignment featured formed in the base can engage a complementary alignment feature on the loading device since it does not appear the loading device ever touches the base when the loading device is inserted into the pusher (see Fig. 9B, 12, 14 and 22, each of which show the loading device loaded within the pusher, but not engaging the base of the pusher).
Claim 12 recites the limitation “the loading device can be radially larger on an axial axis” which renders the scope of the claim indefinite. It is first unclear if the recitation is meant to further limit the claim since the term “can be” indicates the feature may be optional. It also unclear what the loading device is radially larger than given that the claim does not relate the size of the loading device on the axial axis in comparison to any other feature. It is further unclear what “an axial axis” means since it is unclear how the term “axial” further modifies the term “axis”. For examination purposes, this limitation has been interpreted as being optional.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As discussed above, the limitation “complementary alignment feature” in claim 7 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The complementary alignment feature is mentioned only once in the written description (see [0017]) and within the same paragraph “the alignment feature” is further defined as “a keyway such as a radially inwardly extending projection or a radially outwardly extending recess”. However, the description makes clear that the referenced alignment feature is the rotational alignment feature which is formed in the base. The scope of the limitation is further unclear since, as disclosed, the complementary alignment feature on the loading device engages with a part of the base (see [0017]) and, based on the figures, it does not seem that any part of the loading device 40 ever engages the base 64 (see Fig. 9B, 12, 14 and 22, each of which show the loading device loaded within the pusher, but not engaging the base of the pusher).
Claims 8-9 are rejected by virtue of their dependency from claim 7.
Claim Rejections - 35 USC § 102
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 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, 3-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barclay (US 2015/0272587).
Regarding claim 1, Barclay discloses a pusher (see Fig. 2C-3) for loading an elastic band (106) on a ligation device (100, see Fig. 1A), comprising: a base (208); at least two arms (208a) extending in a proximal direction from the base, the arms inclined radially inwardly in the proximal direction and defining a proximal opening (see Fig. 2D); and the arms movable between a first position (which defines a first diameter for the opening (first position and diameter shown in Fig. 2D) and a second, radially outwardly displaced position, which defines a second, larger diameter opening in response to distal advance of a loading device therein (while not shown in the figures, Barclay discloses that as the cone 210 is advanced into the loader, prongs 208a deflect outwardly to accommodate the increasing diameter of the cone, see [0056]).
Regarding claim 3, Barclay discloses a pusher as in Claim 1, comprising three arms (see Fig. 2D).
Regarding claim 4, Barclay discloses a pusher as in Claim 1, wherein the base comprises a radially outwardly extending flange (see annotated Fig. 2D below).
PNG
media_image1.png
671
233
media_image1.png
Greyscale
Regarding claim 5, Barclay discloses a pusher as in Claim 4, wherein the arms are integrally formed with the base (see Fig. 2D).
Regarding claim 6, Barclay discloses a pusher as in Claim 3, further comprising an aperture in the base, in communication with the proximal opening through a central lumen defined by the arms (although not labeled in the figures, it is understood there is are four apertures in the band feeder 208 which are in communication with the proximal openings defined by the sets of prongs 208a through a central lumen since the channel 218 is shown extending through prongs 208a, see Fig. 2C-2D).
Regarding claim 7, Barclay discloses a pusher as in Claim 6, comprising a rotational alignment feature configured to engage a complementary alignment feature on the loading device (the post extending through the center of the band feeder or the slot extending through it can both be considered a rotational alignment feature, which has been interpreted under 35 U.S.C. 112(f) as a projection or recess, and the portion of housing part 204 that aligns with the post to allow fastening by screw 205 is considered a complementary alignment feature since it engages the rotational alignment feature, see Fig. 2C, annotated Fig. 2D and [0053]).
Regarding claim 8, Barclay discloses a pusher as in Claim 7 wherein the rotational alignment feature comprises a keyway formed in the base adjacent the aperture (the slot extending through the post in band feeder 208 is considered a keyway, see annotated Fig. 2D).
Regarding claim 9, Barclay discloses a pusher as in Claim 7 wherein the rotational alignment feature comprises a projection formed in the base adjacent the aperture (the post extending through the center of band feeder 208 is a projection, see annotated Fig. 2D).
Regarding claim 10, Barclay discloses a pusher as in Claim 3, further comprising a ligation band engagement structure on distal ends of the arms, for rolling the ligation band along the loading device (feet 209 are considered ligation band engagement structures, which has been interpreted under 35 U.S.C. 112(f) as a distally facing ramp, see [0051] and Fig. 2D and 3).
Regarding claim 11, Barclay discloses a pusher as in Claim 10, wherein the ligation band engagement structure comprises a distally facing ramp (see feet 209 in Fig. 2D and 3).
Regarding claim 12, Barclay discloses a loading device (210, see Fig. 2D and 3), configured for loading an elastic band (106) onto a ligation device (100), comprising: a body having a proximal end (towards 217) and a distal end (towards 212), the body increasing in diameter from the distal end to the proximal end (see Fig. 3); an engagement structure carried by the proximal end (fin 214 is considered an engagement structure, which has been interpreted under 35 U.S.C. 112(f) as a projection, see Fig. 3), configured for releasable engagement with a distal end of a ligation device (fins 214 releasably engage cup 104 of ligator 100, see Fig. 3 and see also Fig. 5A-5C showing fins 414 engaged within cup 104); an axially extending guide along a surface of the body, for rotational engagement with an elastic band pusher while permitting axial relative movement between the loading device and the pusher (the conical portion of the expansion cone 210 can be considered an axially extending guide that engages with band feeder 208 and permits axial movement between the cone and the pusher, see Fig. 3); and wherein the loading device can control an exact radial expansion of the elastic band to a prescribed percentage (it is noted that the claim does not require that the loading device to control radial expansion of an elastic band in a specific way or even to a specific percentage, therefore the expansion cone 210 of Barclay is considered to be capable of controlling an exact radial expansion of the elastic band to a prescribed percentage since it facilitates expansion of a band 106 for loading onto a ligation device); wherein the loading device can be radially larger on an axial axis (for examination purposes this limitation has been interpreted as not being required by the claim, see 112(b) rejection above, noting “can be” language); wherein the loading device can be isolated from environmental conditions (the expansion cone can be isolated from environmental conditions if desired, see Fig. 6 and [0022]).
Regarding claim 13, Barclay discloses a loading device as in Claim 12, wherein the engagement structure comprises a proximal projection configured to be removably received within a distal aperture on the ligation device (fins 214 are configured to be removably received within the aperture formed in cup 104 of ligator 100, see Fig. 3 and see also Fig. 5A-5C showing fins 414 engaged within cup 104).
Regarding claim 14, Barclay discloses a loading device as in Claim 12, further comprising a ligation band carried proximate the distal end (each cone 210 carries a band 106 near its distal end on shaft 212, see [0053]).
Regarding claim 15, Barclay teaches a kit comprising a ligation device loading kit comprising a pusher as in Claim 1, the loading device as in claim 12, and at least one ligation band (106) (see [0022], [0030] and [0031] and Fig. 6).
Regarding claim 16, Barclay further teaches a ligation device loading kit as in Claim 15, wherein the ligation band is carried by the loading device (see [0053]).
Regarding claim 17, Barclay further teaches a ligation device loading kit as in Claim 15, further comprising a ligation device (100, see Fig. 1A and [0031]), configured to detachably connect to the loading device (see [0055]).
Regarding claim 18, Barclay further teaches a ligation device loading kit as in Claim 15, comprising at least three loading devices and at least three ligation bands (there are four expansion cones 210 and each cone has a band 106, see [0053] and Fig. 2D).
Regarding claim 19, Barclay discloses a method of loading a ligation band onto a ligation device (100, see Fig. 1A), comprising steps of: removably attaching a proximal end of a loading device to a distal end of the ligation device, the loading device carrying a ligation band; positioning a distal end of the loading device into a proximal end of a pusher; and advancing the ligation device distally relative to the pusher, causing the pusher to advance the ligation band proximally along the loading device and onto the ligation device (see [0055]-[0057]).
Regarding claim 21, Barclay discloses a method of treating a patient, comprising steps of: providing a ligation device that has previously deployed a first ligation band into a patient (the ligator 100 can be re-sterilized for reuse and in this way can be considered a ligation device that has previously deployed a first ligation band into a patient, see [0061]); attaching a loading device to a distal end of the ligation device; advancing a second ligation band distally along the loading device by advancing the loading device distally with respect to a pusher such that the pusher advances the second ligation band along the loading device and onto the ligation device; removing the loading device from the ligation device; and deploying the second ligation band into the patient (Barclay further teaches attaching the ligator 100 to the expansion cone and advancing a ligation band distally along the loading device with feet 209 of band feeder 208, removing the expansion cone from the ligator 100 and then using the ligator to deploy a band into a patient, see [0055]-[0057] and [0061]).
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wurster (US 6,066,145) .
Regarding claim 1, Wurster discloses a pusher (38, see Fig. 1-2) for loading an elastic band (2) on a ligation device (34, see Fig. 1), comprising: a base (the bottom portion of the pusher 38, see Fig. 1); at least two arms (there are a plurality of bendable arms 10, see col. 7, lines 26-29) extending in a proximal direction from the base, the arms inclined radially inwardly in the proximal direction and defining a proximal opening (the arms appear to extend radially inwardly since the pusher 38 has a tapered profile, see Fig. 1-2); and the arms movable between a first position which defines a first diameter for the opening and a second, radially outwardly displaced position, which defines a second, larger diameter opening in response to distal advance of a loading device therein (while not expressly stated, it is understood based on Wurster’s disclosure of how the device functions that the arms move between a first position shown in Fig. 1 and a second radially outwardly displaced position when engaged with the shaft 34 to push a ligation ring 2 onto the shaft since the arms are disclosed as bendable and the shaft 34 has an increasing diameter along its longitudinal axis, see col. 7, lines 19-43).
Regarding claim 2, Wurster discloses a pusher as in Claim 1, further comprising an elastic band carried by the arms to bias the arms in the direction of the first position (the arms 10 are joined together by a circular spring 11 which is considered an elastic band, see col. 7, lines 26-29).
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horppu et al. (US 8,491,607).
Regarding claim 19, Horppu discloses a method of loading a ligation band (2, see Fig. 13-18) onto a ligation device (see Fig. 1), comprising steps of: removably attaching a proximal end (20) of a loading device to a distal end of the ligation device (see col. 5, lines 14-18), the loading device carrying a ligation band (2, see Fig. 13); positioning a distal end of the loading device into a proximal end of a pusher; and advancing the ligation device distally relative to the pusher, causing the pusher to advance the ligation band proximally along the loading device and onto the ligation device (see col. 5, line 47- col. 6, line 6).
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over in Horppu view of McGown (US 8,932,306)
Regarding claim 20, Horppu discloses a method of loading a ligation band as in Claim 19, and further teaches a ligation band engagement structure on the proximal end of the pusher (forward ends 30 of the expander device are considered ligation band engagement structures, which has been interpreted under 35 U.S.C. 112(f) as a ramp, since they have a slanted, ramp-like shape, see Fig. 9) which pushes the band along the loading device during the advancing step (see Fig. 13-14). Horppu fails to expressly teach the ligation band rolls during the advancement step.
McGown, in the same field, of art teaches a related method where the elastic band can be either slid or rolled along a loading device (see col. 2, lines 21-27).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Horppu so that the band rolls along the loading device during the advancement step, since causing a band to roll or slide were known alternative ways of moving a band along a loading device, as taught by McGown, and the modification would have yielded nothing more than predictable results, namely, causing the band to roll in the method of Horppu would have resulted in movement along the loading device as intended.
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 (1,12,14,15), 2, 3, 4, 5, 6, 9, 10, 11, 13, 16, 17, 18, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), 2, 3, 4, 5, 6, 9, 10, 11, 13, 16, 17, 18, 19 and 20, respectively, of copending Application No. 18/395,283 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the limitations of the present application are recited in the copending application ‘283 claims, as mapped below:
Present Claims 18/962,509
Copending Claims 18/395,283
1, 12, 14, 15
1
2
2
3
3
4
4
5
5
6
6
9
9
10
10
11
11
13
13
16
16
17
17
18
18
19
19
20
20
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the double patenting rejection is provisional, it is noted that a Notice of Allowance dated 05/26/2026 has been issued in copending Application No. 18/395,283 and the provisional rejection will convert to a non-provisional rejection once the patent is issued.
Conclusion
This is a continuation in part of applicant's earlier Application No. 18/395,283. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights