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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 04/21/2026 is acknowledged.
Examiner notes in an interview with Attorney Iulia Graf on 05/12/2026 and reflected in the Interview Summary Record filed on 05/18/2026, the examiner and attorney agreed that for the purposes of examination the generic claims 18-22 and 34-37 will be examined alongside the elected claims of Species A (claims 23-26 and 29-33). The attorney is instructed to correct the claim headings in their response to this action.
Claims 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/21/2026.
Therefore, claims 18-37 are pending, with claims 27-28 withdrawn from consideration.
Claim Objections
Claims 19, 24, 31-33, and 37 are objected to because of the following informalities:
Regarding claim 19, the phrase “a dispensing operation“ in line 3 should read “the dispensing operation” for clarity,
Regarding claim 24, the phrase “squeeze element (140)” in line 4 should read “squeeze element
Regarding claim 24, the phrase “in radial direction” in line 4 should read “in a radial direction” for proper grammar,
Regarding claim 31, the phrase “to the interface element, for the interface element to be moved the first axial position to the second axial position” in lines 9-10 should read “to the interface elementfrom the first axial position to the second axial position” to remove the comma and add the term “from” for proper grammar,
Regarding claim 32, the phrase “a dispensing operation“ in line 3 should read “the dispensing operation” for clarity,
Regarding claim 33, the phrase “in radial direction” in line 2 should read “in a radial direction” for proper grammar,
Regarding claim 33, the phrase “in radial outward direction” in lines 8-9 should read “in a radial outward direction” for proper grammar,
Regarding claim 37, the phrase “a dispensing operation“ in line 6 should read “the dispensing operation” for clarity,
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:
“a movable element” in claim 20
“a squeeze unit” and “a squeeze element” in claim 23
“an interface element” in claim 29
“a holding element” in claim 30
“an outlet drive unit” in claim 31
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.
Regarding “a movable element” in claim 20, 112(f) is invoked because: (i) it uses a generic placeholder (element), (ii) it is coupled with functional language (movable), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.2, lines 18-24, P.4, lines 12-32, and P.7, lines 22-30 disclose the movable element as a structure that undertakes a repeating, preferably periodically repeating, movement such that with every repetition a portion of the fluid is dispensed from the operating reservoir, and specifically it may be a roller and squeezing arm as seen in peristaltic pumping mechanisms or a flexible diaphragm as seen in diaphragm pumping mechanisms, Examiner is interpreting the limitation as a structure that undertakes a repeating movement such that with every repetition a portion of the fluid is dispensed from a reservoir such as a roller, flexible diaphragm, or equivalent structures of pumping mechanisms.
Regarding “a squeeze unit” and “a squeeze element” in claim 23, 112(f) is invoked because: (i) it uses a generic placeholder (unit, element), (ii) it is coupled with functional language (squeeze), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.4, lines 12-36 discloses the movable element in the form of a squeeze unit which comprises at least one squeeze element for squeezing the operating reservoir. The squeeze unit is a rotatable mechanism comprising at least one arm with each arm having a roller as the squeeze element. Examiner is interpreting the squeeze unit as at least one rotating arm for carrying out a peristaltic mechanism and the squeeze element as a roller or equivalent structures.
Regarding “an interface element” in claim 29, 112(f) is invoked because: (i) it uses a generic placeholder (element), (ii) it is coupled with functional language (interface), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.9, lines 24-25 discloses the interface element as a needle holder connected or integrated with the needle. Examiner is interpreting the interface element as a needle holder or equivalent structures.
Regarding “a holding element” in claim 30, 112(f) is invoked because: (i) it uses a generic placeholder (element), (ii) it is coupled with functional language (holding), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.11, lines 4-P.12, lines 29 discloses the holding element as a collar configured to interact with the button and the needle holder such that initially, the collar locks the needle holder in its unactuated position, and upon actuation of the button, the collar rotates to unlock the needle holder and allow it to move axially. Examiner is interpreting the holding element as a collar or equivalent structure that provides a locking mechanism.
Regarding “an outlet drive unit” in claim 31, 112(f) is invoked because: (i) it uses a generic placeholder (unit), (ii) it is coupled with functional language (outlet drive), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.13, lines 12-18 discloses the outlet drive unit as a drive spring. Examiner is interpreting the outlet drive unit as a drive spring or equivalent structure.
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 21-26 and 29-33 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 21 recites the limitation "the reserve reservoir" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner notes Claim 21 is dependent upon claim 20 which is dependent upon claim 18, and “a reserve reservoir” is introduced in Claim 19. Examiner is interpreting this as the same reserve reservoir in claim 19.
Regarding claim 29, the phrase “an outlet” in line 3 renders the claim indefinite because it is unclear. It is unclear whether this is a different outlet or the aforementioned outlet in claim 18. Examiner is interpreting it as the latter.
Regarding claim 32, the phrase “a circumferentially disposed element which encloses a rotation axis” in line 4 renders the claim indefinite because it is unclear. Claim 32 is dependent upon claim 25 which falls under the dependency tree of claim 21 which already discloses a circumferentially disposed element enclosing a rotation axis. Thus, it is unclear whether this is a different circumferentially disposed element and rotation axis or the same as that in claim 21. Examiner is interpreting it as the latter.
Regarding claims 22-26, 30-31, and 33, these claims are rejected due to their dependency upon a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 fails to further limit the subject matter upon which it depends because claim 33 is dependent upon claim 33. Thus, claim 33 does not further limit itself. Examiner notes for the purposes of examination, examiner is interpreting this claim as being dependent upon claim 23.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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) 18, 20, and 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schabbach et al. (U.S Patent Pub. No. 20190209774 A1, “Schabbach”).
Regarding claim 18, Schabbach discloses (Claim 18) an autoinjector (10 in at least Fig. 1-3) comprising:
a housing (11 in Fig. 1-2) configured to receive an operating reservoir (23 in Fig. 2-3) with a fluid (see para. 0034-0035 and 0043); and
a pump arrangement (see Fig. 1-3) configured to drive the fluid from the operating reservoir (23) towards and through an outlet (12 in Fig. 2-3) of the autoinjector (10) in a dispensing operation (see para. 0091-0092 – the autoinjector 10 comprises a roller 24 rotating around an axle 24A powered by a spring 25 for driving the fluid from the operating reservoir 23 towards and through needle 12).
Regarding claim 20, Schabbach discloses (Claim 20) the autoinjector (10) of claim 18, wherein the pump arrangement comprises a movable element (24, 24A) operatively connected with the operating reservoir (23, examiner notes the movable element is interpreted under 112(f) as a structure that undertakes a repeating movement such that with every repetition a portion of the fluid is dispensed from a reservoir such as a roller, flexible diaphragm, or equivalent structures of pumping mechanisms, see Fig. 2-3 and para. 0044 – pumping arrangement comprises a roller 24 on an axle 24A interpreted together as the movable element which is operatively connected with flexible bag 23), wherein a movement of the movable element (24, 24A) drives at least a portion of the fluid from the operating reservoir (23) to the outlet (12, see para. 0091-0092).
Regarding claim 34, Schabbach discloses (Claim 34) the autoinjector (10) of claim 18, being a disposable or single-use device, for providing a single dose (see para. 0094 – device 10 is removed from the injection site after a single-use providing a single dose).
Regarding claim 35, Schabbach discloses (Claim 35) the autoinjector (10) of claim 18, further comprising the operating reservoir (23) with the fluid (see Fig. 2-3), wherein the fluid is a medicament (see para. 0043).
Regarding claim 36, Schabbach discloses (Claim 36) a method for dispensing a medicament using an autoinjector (10 in Fig. 1-3 and para. 0083 and 0091-0091), the method comprising:
receiving an operating reservoir (23 in Fig. 2-3) containing a medicament in a housing (11 in Fig.1-3) of the autoinjector (10, see para. 0041 and 0043); and
driving the fluid from the operating reservoir (23), using a pump arrangement (see Fig. 2-3) of the autoinjector (10), towards and through an outlet (12 in Fig. 2-3) of the autoinjector (10, see para. 0091-0092 – the autoinjector 10 comprises a roller 24 rotating around an axle 24A powered by a spring 25 for driving the fluid from the operating reservoir 23 towards and through needle 12).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19, 21-24, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Miyazaki et al. (U.S Patent Pub. No. 20070154336 A1, “Miyazaki”).
Regarding claim 19, Schabbach discloses the autoinjector of claim 18, as discussed above.
However, Schabbach fails to disclose (Claim 19) comprising a reserve reservoir in fluid communication with the operating reservoir, and configured to supplement fluid to the operating reservoir during a dispensing operation.
Miyazaki discloses an autoinjector (1 in at least Fig. 1-2) having a peristaltic pumping arrangement (2 in Fig. 2) having movable elements in the form of fingers (40-46 in Fig. 2) that repeat occlusion and release of an operating reservoir (50 in Fig. 2) for peristaltic movement of the medicament therewithin (see para. 0363-0365). Miyazaki teaches (Claim 19) comprising a reserve reservoir (60 in Fig. 2) in fluid communication with the operating reservoir (50, see Fig. 2 and para. 0266), and configured to supplement fluid to the operating reservoir (50) during a dispensing operation (see para. 0360-0365 – the fingers 40-46 cause peristaltic movement of the fluid from the reserve reservoir 60 to the operating reservoir 50 during use).
Since Schabbach discloses an operating reservoir (23) fluidly connected to a filling port (18A in Fig. 2) for filling the operating reservoir (23) with medicament (see para. 0043), and Miyazaki discloses an operating reservoir (50) used in a similar peristaltic fashion as that of Schabbach and comprising a reserve reservoir (60) that is fluidly connected to a filling port (80 in Fig. 2) for filling the reserve reservoir (60) which supplements the operating reservoir (50, see para. 0325), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operating reservoir and filling port of the autoinjector taught by Schabbach to be in fluid communication with a reserve reservoir as taught by Miyazaki. Miyazaki teaches that because the fluid can be injected into the reserve reservoir instead of an operating reservoir, refilling of the reserve reservoir can occur even when the device is in use enabling continuous flow of fluid without having to stop operating to perform refilling (see para. 0042).
Regarding claim 21, Schabbach discloses the autoinjector of claim 18, as discussed above. Schabbach further discloses the limitations (Claim 21) comprising a circumferentially disposed element (18 in Fig. 2) enclosing a rotation axis (A-A in Fig. 2, see para. 0037 and 0044 – distal portion 16 of housing 11 comprises a peripheral wall 18 that is circumferentially disposed and encloses the rotation axis A-A).
However, Schabbach fails to disclose the limitation (Claim 21) the circumferentially disposed element being arranged adjacent to the reserve reservoir radially inward.
Miyazaki discloses an autoinjector (1 in at least Fig. 1-2) having a peristaltic pumping arrangement (2 in Fig. 2) having a circumferentially disposed element (121 in Fig. 2) in the form of a circumferentially disposed tube guide groove (121) which encloses a rotation axis (P in Fig. 2, see para. 0259-0260), wherein Miyazaki teaches (Claim 21) the circumferentially disposed element (121) being arranged adjacent to the reserve reservoir (60 in Fig. 2) radially inward (see Fig. 2 and annotated Miyazaki drawing 1 below – guide tube groove 121 is arranged adjacent and radially inward relative to the rotation axis P of the reserve reservoir 60).
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Since Schabbach discloses an operating reservoir (23) fluidly connected to a filling port (18A in Fig. 2) for filling the operating reservoir (23) with medicament and a circumferentially disposed element (18, see para. 0043-0044), and Miyazaki discloses an operating reservoir (50) used in a similar peristaltic fashion as that of Schabbach and comprising a reserve reservoir (60) that is fluidly connected to a filling port (80 in Fig. 2) for filling the reserve reservoir (60) which supplements the operating reservoir (50) and a circumferentially disposed element (121) adjacent the reserve reservoir (60, see para. 0325), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operating reservoir and filling port of the autoinjector taught by Schabbach to be in fluid communication with a reserve reservoir such that the circumferentially disposed element is positioned adjacent and radially inward of the reserve reservoir as taught by Miyazaki. Miyazaki teaches that because the fluid can be injected into the reserve reservoir instead of an operating reservoir, refilling of the reserve reservoir can occur even when the device is in use enabling continuous flow of fluid without having to stop operating to perform refilling (see para. 0042). Miyazaki further teaches that the reserve reservoir is positioned separate from the pumping arrangement (2) and drive mechanism (3) to ensure that any condensation on a surface of the reservoir does not cause rust formation or circuit problems to improve durability (see para. 0038 and 0047). In combination, a reserve reservoir would be arranged adjacent and radially outward from the peripheral wall (18) of Schabbach as shown by Miyazaki.
Regarding claim 22, modified Schabbach discloses the autoinjector of claim 21, as discussed above. In modified Schabbach, Schabbach discloses (Claim 22) comprising a motor spring (25 in Fig. 1-3) configured to move the movable element (24, see para. 0047, 0088, and 0092 – dispensing spring 25 may take the form of a torsion spring which is biased to store potential energy and when actuated translates said energy into kinetic energy to drive the roller 24).
Regarding claim 23, modified Schabbach discloses the autoinjector of claim 22, as discussed above. In modified Schabbach, Schabbach discloses (Claim 23) wherein the movable element (24, 24A) comprises a squeeze unit (24A) and at least one squeeze element (24) configured to squeeze the operating reservoir (23, examiner notes the squeeze unit and at least one squeeze element are being interpreted under 112(f) with the squeeze unit as at least one rotating arm structure for carrying out a peristaltic mechanism and the squeeze element as a roller or equivalent structures, see para. 0044 – the movable element 24 and 24A comprises an axle 24A interpreted as a rotating arm structure carrying out a peristaltic mechanism and comprises a roller 24 as the squeeze element for squeezing the reservoir 23), wherein the squeeze unit (24A) is rotatable around the rotation axis (A-A in Fig. 2, see para. 0044), such that the at least one squeeze element (24) rotates around the rotation axis (A-A) and thereby squeezes the operating reservoir (23) causing the fluid to be driven within the operating reservoir (23, see para. 0044-0045 and 0092).
Regarding claim 24, modified Schabbach discloses the autoinjector of claim 23, as discussed above. In modified Schabbach, Schabbach discloses (Claim 24) the circumferentially disposed element (18 in Fig. 2) such that it mechanically supports the operating reservoir (23) while it is squeeze by the at least one squeeze element (24) in radial direction (see Fig. 1-3 and para. 0036-0037 – peripheral wall 18 mechanically supports the reservoir 23 in the radial direction as seen in Fig. 1-3 while its squeezed by roller 24).
In modified Schabbach, Miyazaki discloses (Claim 24) wherein the circumferentially disposed element (121 in Fig. 2) is radially arranged between the operating reservoir (50 in Fig. 2) and the reserve reservoir (60, see annotated Miyazaki drawing 1 above – guide tube groove 121 is radially arranged relative to rotation axis P between the tube 50 and reserve reservoir 60).
In combination, the reserve reservoir would be arranged adjacent and radially outward from the peripheral wall (18) of Schabbach as shown by Miyazaki such that the peripheral wall (18) would be radially arranged between the operating reservoir (23) and incorporated reserve reservoir.
Regarding claim 37, Schabbach discloses (Claim 37) an autoinjector (10 in at least Fig. 1-3) comprising:
a housing (11 in Fig. 1-2) configured to receive an operating reservoir (23 in Fig. 2-3) with a fluid (see para. 0034-0035 and 0043); and
a pump arrangement (see Fig. 1-3), configured to drive the fluid from the operating reservoir (23) towards and through an outlet (12 in Fig. 2-3) of the autoinjector (10) in a dispensing operation (see para. 0091-0092);
a circumferentially disposed element (18 in Fig. 2) enclosing a rotation axis (A-A in Fig. 2) and mechanically supports the operating reservoir (23, see para. 0037 and 0044 – distal portion 16 of housing 11 comprises a peripheral wall 18 that is circumferentially disposed and encloses the rotation axis A-A, peripheral wall 18 mechanically supports the reservoir 23 in the radial direction as seen in Fig. 1-3 while its squeezed by roller 24).
However, Schabbach fails to disclose (Claim 37) a reserve reservoir in fluid communication with the operating reservoir and configured to supplement fluid to the operating reservoir during a dispensing operation; a circumferentially disposed element arranged adjacent to the reserve reservoir radially inward, wherein the circumferentially disposed element is radially arranged between the operating reservoir and the reserve reservoir and mechanically supports the operating reservoir.
Miyazaki discloses an autoinjector (1 in at least Fig. 1-2) having a peristaltic pumping arrangement (2 in Fig. 2) having movable elements in the form of fingers (40-46 in Fig. 2) that repeat occlusion and release of an operating reservoir (50 in Fig. 2) for peristaltic movement of the medicament therewithin (see para. 0363-0365). Miyazaki teaches (Claim 37) comprising a reserve reservoir (60 in Fig. 2) in fluid communication with the operating reservoir (50 in Fig. 2) and configured to supplement fluid to the operating reservoir (50) during a dispensing operation (see para. 0266, 0360-0365 – the fingers 40-46 cause peristaltic movement of the fluid from the reserve reservoir 60 to the operating reservoir 50 during use); a circumferentially disposed element (121 in Fig. 2) being arranged adjacent to the reserve reservoir (60) radially inward (see Fig. 2 and annotated Miyazaki drawing 1 above – guide tube groove 121 is arranged adjacent and radially inward relative to the rotation axis P of the reserve reservoir 60), wherein the circumferentially disposed element (121 in Fig. 2) is radially arranged between the operating reservoir (50 in Fig. 2) and the reserve reservoir (60) and mechanically supports the operating reservoir (50, see annotated Miyazaki drawing 1 above and para. 0259-0260 – guide tube groove 121 is radially arranged relative to rotation axis P between the tube 50 and reserve reservoir 60 to mechanically support the tube 50).
Since Schabbach discloses an operating reservoir (23) fluidly connected to a filling port (18A in Fig. 2) for filling the operating reservoir (23) with medicament and a circumferentially disposed element (18, see para. 0043-0044), and Miyazaki discloses an operating reservoir (50) used in a similar peristaltic fashion as that of Schabbach and comprising a reserve reservoir (60) that is fluidly connected to a filling port (80 in Fig. 2) for filling the reserve reservoir (60) which supplements the operating reservoir (50) and a circumferentially disposed element (121) adjacent the reserve reservoir (60, see para. 0325), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operating reservoir and filling port of the autoinjector taught by Schabbach to be in fluid communication with a reserve reservoir such that the circumferentially disposed element is positioned adjacent and radially inward of the reserve reservoir as taught by Miyazaki. Miyazaki teaches that because the fluid can be injected into the reserve reservoir instead of an operating reservoir, refilling of the reserve reservoir can occur even when the device is in use enabling continuous flow of fluid without having to stop operating to perform refilling (see para. 0042). Miyazaki further teaches that the reserve reservoir is positioned separate from the pumping arrangement (2) and drive mechanism (3) to ensure that any condensation on a surface of the reservoir does not cause rust formation or circuit problems to improve durability (see para. 0038 and 0047). In combination, a reserve reservoir would be arranged adjacent and radially outward from the peripheral wall (18) of Schabbach as shown by Miyazaki such that it is located between the operating reservoir (23) of Schabbach and the incorporated reserve reservoir.
Claim(s) 25-26, 29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Miyazaki as applied to claims 23-25 above, and further in view of Samakar (U.S Patent Pub. No. 20200297536 A1) in view of Olivas et al. (U.S Patent Pub. No. 20210154410 A1, “Olivas”) and in view of Kim et al. (U.S Patent Pub. No. 20220176034 A1, “Kim”).
Regarding claim 25, modified Schabbach discloses the autoinjector of claim 24, as discussed above.
However, modified Schabbach fails to disclose (Claim 24) comprising a rotary gear system mechanically connected to the squeeze unit, and configured to cause the squeeze unit to rotate around the rotation axis, wherein a speed of rotation of the squeeze unit is determined by a gear ratio of the rotary gear system.
Samakar discloses a peristaltic micropump (100 in Fig. 1-3) with a roller (134 in Fig. 3) attached to a rotor (136 in Fig. 3) further attached to a drive shaft (132 in Fig. 3, see para. 0037). The drive shaft (132) is then attached to a gear (138 in Fig. 6) which couples to a gear box (116 in Fig. 2) which couples to a motor (114 in Fig. 2) to thus transmit rotational energy from the motor (114) to the gear box (116) to the gear (138) to the roller (134, see para. 0035 and 0047). Samakar teaches (Claim 25) comprising a rotary gear system (116, 136 in Fig. 2 and 6) mechanically connected to the squeeze unit (136, see para. 0035 and 0047 – rotor 136 is an arm-like structure rotating around the first axis to carry out a peristaltic pumping mechanism), and configured to cause the squeeze unit (136) to rotate around the rotation axis (“first axis” in para. 0037).
Olivas discloses a drug delivery device (10 in Fig. 1) comprising a drive assembly (24 in Fig. 1) for driving the dispensing operation (see para. 0026), wherein the drive assembly (24) is in the form of a rotary gear system (72 in Fig. 1 and 5) coupled to a rotational power source (70 in Fig. 1 and 5) which may be in the form of an electromotor or a torsion spring (see para. 0035-0036). Thus, Olivas teaches how a torsion spring can be coupled to a rotary gear system for transmitting said rotational energy from the torsion spring, to the rotary gear system, to the pumping arrangement.
Since Samakar teaches a motor-driven rotary gear system for driving a roller pumping arrangement (see para. 0035 and 0047 of Samakar), and Olivas teaches that a motor-driven rotary gear system for driving a pumping arrangement may comprise a torsion spring as the motor coupled to the rotary gear system (see para. 0035-0036 of Olivas), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the drive mechanism of the pump arrangement of modified Schabbach to incorporate a gear box and gear coupled to the drive shaft as taught by Schabbach, in such a way that the torsion spring is coupled to the rotary gear system which is coupled to the roller pumping arrangement as taught by Olivas. Samakar teaches that a gear box is able to increase or decrease the torque applied form the motor to achieve the desired torque for overcoming the friction with the roller assembly and driving the dispensing operation (see para. 0035), and Olivas provides a teaching that one of ordinary skill in the art would have recognized as a known method for mechanically coupling a torsion spring to a rotary gear system to a pumping arrangement to yield predictable results.
Kim discloses a drug delivery device (2 in Fig. 9) comprising a peristaltic pumping arrangement (230 in Fig. 9-10) comprising rollers (231a, 231b in Fig. 10) that are driven by a rotary gear system (34, 210 in Fig. 9-10) coupled to a drive module (30-2 in Fig. 9, see para. 0142, 0149-0150, 0160), wherein Kim teaches wherein a gear ratio of the rotary gear system (34, 210) is determined according to amount of drug to be discharged and a drug injection period (see para. 0142 and 0155). Examiner notes that the amount of drug to be discharged in a period of time is a direct indication of the speed of rotation of the squeeze unit (230) which is thus a function of the gear ratio of the rotary gear system (34, 210).
Since modified Schabbach discloses a rotary gear system coupled to the squeeze unit for transmitting rotational energy thereto, and Kim discloses a rotary gear system coupled to a squeeze unit for transmitting rotational energy thereto, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rotary gear system of modified Schabbach to have a gear ratio that determines the speed of rotation of the squeeze unit as taught by Kim. Kim teaches that the gear ratio of the rotary gear system is determined according to the amount of drug to be discharged and a drug injection period which allows for precise control and discharge of the drug without comprising stability or durability of the device due to overload or heat generation (see para. 0142 and 0155).
Regarding claim 26, modified Schabbach discloses the autoinjector of claim 25, as discussed above.
In modified Schabbach, Schabbach discloses the motor spring (25 in Fig. 2-3 and para. 0047).
In modified Schabbach, Samakar discloses the rotary gear system (116, 138 in Fig. 2 and 6 and para. 0035 and 0047).
In modified Schabbach, Olivas discloses a drug delivery device (10 in Fig. 1) comprising a drive assembly (24 in Fig. 1) for driving the dispensing operation (see para. 0026), wherein the drive assembly (24) is in the form of a rotary gear system (72 in Fig. 1 and 5) coupled to a rotational power source (70 in Fig. 1 and 5) which may be in the form of an electro motor or a torsion spring (see para. 0035-0036).
Thus, in combination, modified Schabbach discloses (Claim 26) the motor spring (25) of Schabbach mechanically connected to the rotary gear system (116, 138) of Samakar as taught by Olivas.
Regarding claim 29, modified Schabbach discloses the autoinjector of clam 25, as discussed above. In modified Schabbach, Schabbach discloses (Claim 29) comprising an outlet drive mechanism comprising:
an outlet (12),
an interface element (12A in Fig. 5) connected to or integrated with the outlet (12, examiner notes the interface element is interpreted under 112(f) as a needle holder or equivalent structures, see Fig. 5 and para. 0064 – the base 12A is integrated with needle 12 as seen in Fig. 5 and is an equivalent structure to a needle holder), wherein the interface element (12A) is movable from a first axial position (see Fig. 4) to a second axial position (see Fig. 6) along the rotation axis (A-A, see para. 0060-0061 – first axial position is the retracted position of needle 12 and thus also its base 12A and both structures are movable to a second axial position as the extended position),
a trigger (15 in Fig. 1-2) operatively connected to the interface element (12A) wherein
the trigger (15) is movable from a first trigger position (see Fig. 4) to a second trigger position (see Fig. 2) along the rotation axis (A-A, see para. 0059 and 0092), wherein
in the first trigger position (see Fig. 4) the interface element (12A) is releasably locked from moving from the first axial position (see Fig. 4) to the second axial position (see Fig. 6, para. 0069 and 0072 – when button 15 is undepressed and in first trigger position seen in Fig. 4, base 12A is releasably locked from moving by needle extension lock 36), and
in the second trigger position (see Fig. 2), the interface element (12A) is movable to the second axial position (see Fig. 6, see para. 0072 – when button 15 is depressed to second trigger position see in Fig. 2, needle extension lock 36 is unlocked as seen in Fig. 5 allowing base 12A to move to second position in Fig. 6)
the movement of the trigger (15) from the first trigger position (see Fig. 4) to the second trigger position (see Fig. 2) causes the interface element (12A) to be released from the first axial position (see Fig. 4) such that the interface element (12A) is movable to the second axial position (see Fig. 6, see para. 0069 and 0072).
Regarding claim 32, modified Schabbach discloses the autoinjector of claim 25, as discussed above. In modified Schabbach, Schabbach discloses the limitations of (Claim 32) comprising a circumferentially disposed element (18 in Fig. 2) which encloses a rotation axis (A-A in Fig. 2) and mechanically supports the operating reservoir (23, see para. 0037 and 0044 – distal portion 16 of housing 11 comprises a peripheral wall 18 that is circumferentially disposed and encloses the rotation axis A-A and mechanically supports the reservoir 23 as seen in Fig. 2-3).
In modified Schabbach, Miyazaki discloses (Claim 32) comprising a reserve reservoir (60 in Fig. 2) in fluid communication with the operating reservoir (50 in Fig. 2) and configured to supplement fluid to the operating reservoir (50) during a dispensing operation (see para. 0266, 0360-0365 – the fingers 40-46 cause peristaltic movement of the fluid from the reserve reservoir 60 to the operating reservoir 50 during use); a circumferentially disposed element (121 in Fig. 2) being arranged adjacent to the reserve reservoir (60) radially inward (see Fig. 2 and annotated Miyazaki drawing 1 above – guide tube groove 121 is arranged adjacent and radially inward relative to the rotation axis P of the reserve reservoir 60), wherein the circumferentially disposed element (121 in Fig. 2) is radially arranged between the operating reservoir (50 in Fig. 2) and the reserve reservoir (60) and mechanically supports the operating reservoir (50, see annotated Miyazaki drawing 1 above and para. 0259-0260 – guide tube groove 121 is radially arranged relative to rotation axis P between the tube 50 and reserve reservoir 60 to mechanically support the tube 50).
In combination, a reserve reservoir would be arranged adjacent and radially outward from the peripheral wall (18) of Schabbach as shown by Miyazaki such that it is located between the operating reservoir (23) of Schabbach and the incorporated reserve reservoir.
Claim(s) 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Miyazaki in view of Samakar in view of Olivas in view of Kim as applied to claim 29 above, and further in view of Destefano et al. (U.S Patent Pub. No. 20180021508 A1, “Destefano”).
Regarding claim 30, modified Schabbach discloses the autoinjector of claim 29, as discussed above.
While Schabbach discloses a holding element in the form of a pivotable locking arm (38 in Fig. 5) in mechanical contact with the interface element (12A, see para. 0069), wherein the pivotable locking arm (38) is rotatable relative to the interface element (12A) from a blocking position to a release position (see Fig. 5 and para. 0069 and 0072 – arm 38 rotates around pivot point 39 from a blocked position to a release position), wherein in the blocking position the interface element (12A) is releasably locked by the pivotable locking arm (38) to move from the first axial position (see Fig. 4) to the second axial position (see Fig. 6, see para. 0069 and 0072), and in the release position the interface element (12A) is movable from the first axial position (see Fig. 4) to the second axial position (see Fig. 6, see para. 0072), wherein the movement of the trigger (15) from the first trigger position (see Fig. 4) to the second trigger position (see Fig. 2) causes the pivotable locking arm (38) to rotate from the blocking position to the release position (see para. 0072), Schabbach fails to disclose the holding element as interpreted under 112(f) as a collar or equivalent structure that provides a locking mechanism and (Claim 30) wherein the holding element is rotatable around the rotation axis relative to the interface element from a blocking position to a release position.
Destefano disclose a similar needle drive mechanism (200 in Fig. 3A-3B and 8-10) comprising a needle (214 in Fig. 8B), an interface element (212 in Fig. 8B) as the needle hub connected to or integrated with the outlet (214, see para. 0097), wherein the interface element (212) is movable from a first axial position (see Fig. 8B) to a second axial position (see Fig. 9B) along a longitudinal axis of the needle (214, see para. 0108 and 0118), a trigger (14 in Fig. 1A) in the form of an activation button operatively connected to the interface element (212) and movable from a first trigger position to a second trigger position along the longitudinal axis (see para. 0111), wherein in the first trigger position the interface element (212) is releasably locked from moving from the first axial position (Fig. 8B) to the second axial position (Fig. 9B) and in the second trigger position the interface element (212) is movable to the second axial position (Fig. 9B) wherein the movement of the trigger (14) to the second trigger position causes the interface element (212) to be released from the first axial position (Fig. 8B) such that it is movable to the second axial position (Fig. 9B, see para. 0111, 0114, and 0118). Destefano teaches (Claim 30) a holding element (202 in Fig. 3A-3B, examiner notes the holding element is interpreted under 112(f) as a collar or equivalent structure that provides a locking mechanism, see para. 0101 – housing 202 is a collar-like structure enclosing the needle hub 212 and needle 214 and rotatable for release of the locking mechanism), the holding element (202) in mechanical contact with the interface element (212, see Fig. 8B and para. 0101), wherein the holding element (202) is rotatable around the longitudinal axis relative to the interface element (212) from a blocking position to a release position (see para. 0101 and 0111), wherein in the blocking position the interface element (212) is releasably locked by the holding element (202) to move from the first axial position (Fig. 8B) to the second axial position (Fig. 9B, see para. 0118), and in the release position the interface element (212) is movable from the first axial position (Fig. 8B) to the second axial position (Fig. 9B, see para. 0118), wherein the movement of the trigger (14) from the first trigger position to the second trigger position causes the holding element (202) to rotate from the blocking position to the release position (see para. 0111, 0114, and 0118).
Since Schabbach discloses a needle insertion mechanism with a locking mechanism and Destefano discloses a similar needle insertion mechanism with a locking mechanism, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pivotable locking mechanism of the needle insertion mechanism of modified Schabbach to be rotational locking mechanism of the needle insertion mechanism of Destefano such that the pivotable locking arm (38) of Schabbach is replaced with the rotatable housing (202) of Destefano with the trigger button and needle hub modified accordingly for operation with said rotatable housing (202). Both Schabbach and Destefano disclose equivalent locking mechanisms for a needle insertion mechanism functioning with a manually depressible trigger button that triggers rotation of a locking structure wherein said rotation releases a needle hub to allow needle insertion. One of ordinary skill in the art could have substituted the locking mechanism of Schabbach with that of Destefano as they are both know locking mechanisms for needle insertion mechanisms, and the results of said substitution would have been predictable.
Regarding claim 31, modified Schabbach discloses the autoinjector of claim 30, as discussed above. In modified Schabbach, Schabbach discloses (Claim 31) comprising an outlet drive unit (32 in Fig.3-4) operatively connected to the trigger (15 in Fig. 3-4) and to the interface element (12A in Fig. 3-5, see para. 0064), wherein the outlet drive unit (32) being configured to provide energy for moving the interface element (12A) from the first axial position (see Fig. 4) to the second axial position (see Fig. 6, see para. 0065), wherein the outlet drive unit (32) has a first drive unit state and a second drive unit state (see para. 0065), wherein in the first drive unit state the outlet drive unit (32) has energy stored and the interface element (12A) is in the first axial position (see Fig. 4) and pivotable, locking arm (38 in Fig. 5) is in the blocking position and the interface element (12A) is prevented from moving to the second axial position (see Fig .6, see para. 0065 and 0069 – in first state, spring 32 is in a compressed state, base 12A is in retracted position and locked by arm 38), and in the second drive unit state the outlet drive unit (32) transfers energy to the interface element (12A), for the interface element (12A) to be moved the first axial position (Fig. 4) to the second axial position (Fig. 6) along the rotation axis (A-A) when the pivotable, locking arm (38) is in the release position (see para. 0072), wherein the movement of the trigger (15) from the first trigger position (Fig. 4) to the second trigger position (Fig. 2) causes the outlet drive unit (32) to change from the first drive unit state to the second drive unit state (see para. 0072).
In modified Schabbach, Destefano discloses the holding element (202) and an equivalent needle drive unit as rotational biasing member (210 in Fig. 3A-3B and 9B, see para. 0102-0103, 0108 and 0118).
Claim(s) 33 is rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Miyazaki as applied to claim 23 above, and further in view of Samakar.
Regarding claim 33, Examiner notes for the purposes of examination, examiner is interpreting this claim as being dependent upon claim 23. Thus, modified Schabbach discloses the autoinjector of claim 23, as discussed above. In modified Schabbach, Schabbach discloses (Claim 33) wherein the squeeze unit (24A) comprises an arm orientated in radial direction (see Fig. 3 and para. 0045-0046 – axle 24A is an elongated arm oriented in the radial direction relative to rotation axis A-A in Fig. 2), the at least one squeeze element (24) is a roller arranged at one end of the arm (see Fig. 3 – roller 24 is arranged at one end of the axle 24A seen in Fig. 3), the at least one squeeze element (24) is configured to rotate around a further rotation axis (B-B in Fig. 2) while rotating at the same time around the rotation axis (A-A, see para. 0045-0046).
While Schabbach discloses the roller (24) rotating around the rotation axis (A-A) while also rotating at the same time around a further rotation axis (B-B), Schabbach discloses that the further rotation axis (B-B) is perpendicular to the rotation axis (A-A) and the roller (24) presses against the operating reservoir (23) on a top surface of the operating reservoir (23, see Fig. 2-3). Thus, modified Schabbach fails to disclose (Claim 33) wherein the further rotation axis is parallel to the rotation axis, the squeeze unit is arranged such that when the at least one squeeze element squeezes the operating reservoir, the at least one squeeze element presses against the operating reservoir in radial outward direction.
Samakar discloses a peristaltic micropump (100 in Fig. 1-3) with a roller (134 in Fig. 3) attached to a rotor (136 in Fig. 3) and configured for pressing radially outwardly on a circumferentially arranged flexible, operating reservoir (124 in Fig. 2) supported by a circumferentially disposed element (122 in Fig. 2, see para. 0039). Samakar teaches the roller (134) rotating around a rotation axis (“first axis” in para. 0041) while also rotating at the same time around a further rotation axis (“second axis” in para. 0041), wherein the further rotation axis (“second axis” in para. 0041) is parallel to the rotation axis (“first axis” in para. 0041 – because the operating reservoir 124 is circumferentially disposed and radially outward from roller 134, the second axis is parallel to the first axis located around the drive shaft 132), the squeeze unit is arranged such that when the roller (134) squeezes the operating reservoir (124), the roller (134) presses against the operating reservoir (124) in radial outward direction (see para. 0041).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operating reservoir and pumping arrangement taught by modified Schabbach to incorporate a circumferentially disposed operating reservoir and roller that presses against the operating reservoir radially outwardly as taught by Samakar according to known methods to yield predictable results. Both Schabbach and Samakar disclose a flexible reservoir that is pressurized using a planetary motion of a roller compressing the reservoir in a circular motion. Thus, one of ordinary skill in the art would have recognized that modifying the orientation of the operating reservoir and direction of rotation about the further axis of Schabbach to have the circumferentially disposed operating reservoir with the further rotation axis being parallel to the first rotation axis as taught by Samakar would yield results that are predictable. Samakar further teaches that the planetary motion of the roller spinning about the second axis while also spinning around the first axis aids in reducing friction (see para. 0041).
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 18, 20, 22-23, and 34-36, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16-17, 19, 23, 29-31, and 33 of copending Application No. 18/267,037. See Table below for mapping of claims.
Regarding claim 18 of the instant application, although the claim at issue is not identical, it is not patentably distinct from claim 16 of the reference application because all of the claimed elements of claim 18 of the instant application can be found in claim 16 of the reference application. The difference between the claim of the instant application and the claim of the issued patent lie in the fact that the reference application includes a more specific “squeezing arrangement” rather than the broader “pumping arrangement” of the instant application. Thus, the invention of claim 16 of the reference application is in effect “a species” of the “generic” invention of claim 18 of the instant 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 18 of the instant application is anticipated by claim 16 of the reference application, it is not patentably distinct from claim 16 of the reference application.
Regarding claims 20, 22-23, and 34-36 of the instant application, for the discussed reasons above, the claims of the instant application are not patentably distinct from claims 16-17, 19, 23, 29-31, and 33 of the reference application because all of the claimed elements of the instant application can be found in the claims of the reference application as cited below in the Table, and the reference application is in effect “a species” of the “generic” invention of the instant application.
Examiner notes with specific reference to claim 23 of the instant application and claims 23 and 31 of the reference application, the instant claim recites “a squeeze unit and at least one squeeze element”, interpreted under 112(f) as corresponding to a roller arrangement disclosed in the specification and equivalents thereof, whereas the copending claims expressly recite a roller. The claims therefore are not patentably distinct because both claims encompass substantially the same roller-based squeezing arrangement.
This is a provisional nonstatutory double patenting rejection.
Claims of Instant Application (18/267,044)
Claims of Reference Application (18/267,037)
18
16
20
17
22
19
23
23, 31
34
30
35
29
36
33
Conclusion
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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