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 with traverse of species A in the reply filed on 09/14/2025 is acknowledged. The traversal is on the ground(s) that there would be no serious burden on the Examiner to examine the present application in its entirety, regardless of whether or not a prima facie case of serious burden has been shown. This is not found persuasive because each species as set forth above contains independent and distinct elements from the other, each of which may be a point of novelty. Each species requires a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries) and/or the prior art applicable to one species would not likely be applicable to another species.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim(s) 1, 4, 5, 12, 24, 26, 36, 47 is/are objected to because of the following informalities:
Claim 1, line 2, “A mechanical power reserve” should be ““[[A]] a mechanical power reserve”.
Claim 1, line 3, “An escapement which regulates the release of energy from the mechanical power reserve” should be “[[An]] an escapement which regulates the release of energy from the mechanical power reserve”.
Claim 1, line 5, “A pump” should be “[[A]] a pump”.
Claim 4, line 6, “and wheel train to move in” should be “and the wheel train to move in”.
Claim 5, line 3, “and wheel train turn” should be “and the wheel train turn”.
Claim 12, line 2, “A housing” should be “[[A]] a housing”.
Claim 12, line 3, “A winding crown” should be “[[A]] a winding crown”.
Claim 12, line 4, “A mechanical power reserve” should be “[[A]] a mechanical power reserve”.
Claim 12, line 6, “by which power is transferred from the mechanical power reserve” should be “by which the power is transferred from the mechanical power reserve”.
Claim 12, line 6, “A wheel train” should be “[[A]] a wheel train”.
Claim 12, line 8, “A main infusion wheel” should be “[[A]] a main infusion wheel”.
Claim 12, line 9, “An escapement” should be “[[An]] an escapement”.
Claim 12, line 11, “attached to balance wheel” should be “attached to the balance wheel”.
Claim 12, line 11, “swing in precise increment” should be “swing in precise increments”.
Claim 12, line 12, “connected to pallet fork” should be “connected to the pallet fork”.
Claim 12, line 13, “the escape wheel, wheel train, and main infusion wheel” should be “the escape wheel, the wheel train, and the main infusion wheel”.
Claim 24, line 3, “the winding crown and wheel train” should be “the winding crown and the wheel train”.
Claim 26, line 2, “A housing” should be “[[A]] a housing”.
Claim 26, line 3, “A winding crown” should be “[[A]] a winding crown”.
Claim 26, line 4, “A mechanical power reserve” should be “[[A]] a mechanical power reserve”.
Claim 26, line 5, “A wheel train” should be “[[A]] a wheel train”.
Claim 26, line 6, “An escapement” should be “[[An]] an escapement”.
Claim 26, line 8, “A main infusion wheel” should be “[[A]] a main infusion wheel”.
Claim 26, line 9, “Wherein the main infusion wheel” should be “wherein the main infusion wheel”.
Claim 36, line 3, “the winding crown and wheel train” should be “the winding crown and the wheel train”.
Claim 36 and claim 37 are identical. Examiner suggests Applicant to either cancel one of the claims or amend one of the claims to be different than the other.
Claim 47, line 2, “Providing a mechanical power reserve” should be “providing a mechanical power reserve”.
Claim 47, line 3, “Providing a means for storing energy” should be “providing a means for storing energy”.
Claim 47, line 4, “Providing a pump” should be “providing a pump”.
Claim 47, line 5, “Regulating the release of energy” should be “regulating the release of energy”.
Claim 47, line 7, “Transferring the energy” should be “transferring the energy”.
Claim 47, line 9, “Using the energy” should be “using the energy”.
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.
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.
Claim(s) 1-6, 10-12, 24 is/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.
Regarding claim 1, the phrase "a pump" recited in line 5 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “a mechanical pump” recited in line 1 of claim 1. For the purpose of compact prosecution, they are interpreted to be the same.
Claims 2-6 and 10-11 are rejected by virtue of depending on claim 1.
Regarding claim 12, the phrase "a main infusion wheel which powers a pump" recited in line 8 renders the claim indefinite because it is unclear whether the limitation “a main infusion wheel” in line 8 is the same as or different from “a main infusion wheel” in lines 6-7. For the purpose of compact prosecution, they are interpreted to be the same.
Claim 24 is rejected by virtue of depending on claim 12.
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) 1-3, 11, 26, 35-38, 47-49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koch et al. (US 2018/0304029).
Regarding claim 1, Koch discloses
An apparatus for a mechanical pump (figs. 1-28 and pars. 0042-0082), comprising
A mechanical power reserve (254, fig. 8a and pars. 0060, 0066, and 0074);
An escapement (252, fig. 8a and pars. 0060-0061, 0074) which regulates the release of energy from the mechanical power reserve (Examiner notes: see pars. 0067-0078 for activation of the device, injection operation and pausing of the injection. Koch discloses the inwards pressing of the activation buttons causes the injection to start such that the tensioned energy from 254 oscillate 252 to cause rotations of other elements); and,
A pump (66, fig. 9 and pars. 0045, and 0076), wherein the pump is powered by the energy released from the mechanical power reserve (Examiner notes: see pars. 0073-0076 for start of injection and injection operation. Koch discloses the inwards pressing of the activation buttons causes the injection to start such that the tensioned energy from 254 oscillate 252 to cause rotations of 40, 50, 52, 56, 61 and to move 68 and 74 towards the stopper 69 in the medicament container 70 to perform injection of medicament).
Regarding claim 2, Koch discloses
The apparatus of claim 1 also comprising means for storing energy in the mechanical power reserve (Examiner notes: see fig. 8a and pars. 0060, 0066, and 0074 for 254 being a spring storing energy such that the energy is released to oscillate 252 and causing rotations of other elements).
Regarding claim 3, Koch discloses
The apparatus of claim 1 also comprising a wheel train (213, fig. 8a and pars. 0058-0059), wherein the wheel train (213) comprises a series of gears and wheels (see figs. 8a-8b) through which the energy from the mechanical power reserve is transferred to the pump (see pars. 0074-0076).
Regarding claim 11, Koch discloses
The apparatus of claim 1 wherein the mechanical power reserve comprises at least one mainspring (38), barrel (40) and gear (46) forming a mainspring assembly (50, fig. 5 and pars. 0043-0044).
Regarding claim 26, Koch discloses
An apparatus for a mechanically wound infusion pump (figs. 1-28 and pars. 0042-0082), comprising
A housing (10/12);
A winding crown (252, figs. 8a-8b and pars. 0060-0061, 0074);
A mechanical power reserve (254, fig. 8a and pars. 0060, 0066, and 0074) connected to the winding crown (see fig. 8a);
A wheel train (213, figs. 8a-8b and pars. 0058-0059) connected to the mechanical power reserve (254);
An escapement (240, figs. 8a-8b and pars. 0059-0060) which regulates the release of energy from the mechanical power reserve (254) through the wheel train (213, see fig. 8a and pars. 0067-0078 for activation of the device, injection operation and pausing of the injection. Koch discloses the inwards pressing of the activation buttons causes the injection to start such that the tensioned energy from 254 oscillate 252 to cause rotations of other elements);
A main infusion wheel (238, fig. 8a and par. 0059); and,
Wherein the main infusion wheel (238) is turned by the wheel train (213, see fig. 8a).
Regarding claim 35, Koch discloses
The apparatus of claim 26 wherein the main infusion wheel (238) powers a pump (66, fig. 9 and pars. 0045 and 0076) (Examiner notes: see pars. 0067-0078 for rotation of 238 causing movement of 66 towards the stopper 69 in the medicament container 70 to perform injection of medicament).
Regarding claim 36, Koch discloses
The apparatus of claim 26 wherein the mechanical power reserve comprises at least one mainspring (38), barrel (40) and gear (46) forming a mainspring assembly (50, fig. 5 and pars. 0043-0044), the mainspring assembly (50) being connected to the winding crown (252) and wheel train (213) (see figs. 8a-8b).
Regarding claim 37, Koch discloses
The apparatus of claim 26 wherein the mechanical power reserve comprises at least one mainspring (38), barrel (40) and gear (46) forming a mainspring assembly (50, fig. 5 and pars. 0043-0044), the mainspring assembly (50) being connected to the winding crown (252) and wheel train (213) (see figs. 8a-8b).
Regarding claim 38, Koch discloses
The apparatus of claim 26 wherein the wheel train (213) comprises a series of gears (see fig. 8a) turned by the main power reserve (254) and regulated by the escapement (240, see figs. 8a-8b and pars. 0067-0078).
Regarding claim 47, Koch discloses
A method of pumping fluid without using electricity (figs, 1-28 and pars. 0042-0082) comprising;
Providing a mechanical power reserve (252 with 254, fig. 8a and pars. 0060, 0066, and 0074);
Providing a means for storing energy (254 being a spring storing energy such that the energy is released to oscillate 252 and causing rotations of other elements, see fig. 8a and pars. 0060, 0066, 0074) within the mechanical power reserve (252 with 254);
Providing a pump (66, fig. 9 and pars. 0045 and 0076);
Regulating the release of energy from the mechanical power reserve (252/254) through the use of an escapement (240, figs. 8a-8b and pars. 0059-0060. See also pars. 0067-0078 for activation of the device, injection operation and pausing of the injection);
Transferring the energy from the mechanical power reserve (252/254) through a series of gears (213) to the pump (66) (see figs. 8a-9 and pars. 0067-0078); and,
Using the energy released from the mechanical power reserve (252/254) to power the pump (66) (see figs. 8a-9 and pars. 0067-0078).
Regarding claim 48, Koch discloses
The method of claim 47 wherein the mechanical power reserve (252/254) comprises at least one mainspring (38), barrel (40) and gear (46) forming a mainspring assembly (50, fig. 5 and pars. 0043-0044).
Regarding claim 49, Koch discloses
The method of claim 48 also comprising turning a winding crown (24/28) attached to the mainspring assembly (50, see fig. 5) in order to store energy in the mainspring assembly (pars. 0043-0044).
Claim(s) 1, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mossman et al. (US 6,267,559)
Regarding claim 1, Mossman discloses
An apparatus for a mechanical pump (see figs. 1-6 and col. 3 line 12 to col. 6 line 43 for pump system 1), comprising
A mechanical power reserve (20, fig. 1 and col. 3 lines 27-50 for 20 being energy storage element);
An escapement (4, fig. 1 and col. 3 lines 12-26) which regulates the release of energy from the mechanical power reserve (see col. 3 lines 27-50 for the storage energy from 20 being applied to 4 effectively assisting 2 while it is working against 10); and,
A pump (10), wherein the pump is powered by the energy released from the mechanical power reserve (see col. 3 lines 12-50 for the storage energy from 20 being applied to 4 effectively assisting 2 while it is working against 10, and 2 drives 4 with several cams 8 to selectively engage with 10 to compress various portions of an IV tubing).
Regarding claim 10, Mossman discloses
The apparatus of claim 1 wherein the pump (10) comprises a linear peristaltic pump (see fig. 1 and col. 2 lines 9-55), wherein the mechanical power reserve (20) turns a series of gears (6) that operate a series of compression elements (8/10), causing said elements (8/10) to compress and relax a length of flexible tubing (12) in sequence, thereby pumping fluid through the flexible tubing (see col. 3 lines 12-50).
Allowable Subject Matter
Claim(s) 12 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim(s) 4-6 and 24 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of records is/are Koch et al. (US 2018/0304029).
Regarding claim 12, the cited prior art fails to disclose/teach among all the limitation or render obvious an apparatus for a mechanically wound infusion pump, comprising: a housing; a winding crown; a mechanical power reserve, connected to the winding crown such that when the winding crown is twisted, power is stored in the mechanical power reserve; a wheel train by which power is transferred from the mechanical power reserve to a main infusion wheel; a main infusion wheel which powers a pump; and, an escapement comprising an escape wheel, a balance wheel, a pallet fork, and a hairspring, wherein the escape wheel is attached to the wheel train, and wherein the hairspring is attached to balance wheel to allow the balance wheel to swing in precise increment, and wherein the balance wheel is connected to pallet fork which causes the pallet fork to move back and forth in precise increments, which in turn causes the escape wheel, wheel train, and main infusion wheel to move in precise increments, which allows for precise determination of the amount of fluid to be pumped, controlled by the rate of rotation of the main infusion wheel, in combination with the total structure and function as claimed. No combination of prior art was found to teach or suggest each and every element of claim 12.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783