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 the Restriction/Election requirement mailed on December 29th, 2025 in the reply filed on February 28th, 2026 is acknowledged. The traversal is on the ground(s) that the claims are coextensive or interrelated so as to allow examination in a single application and would not pose an undue burden on the examiner. Applicant further continues to cite section 803 of the MPEP quoting the necessity of undue burden on the examiner for restriction to be proper. These arguments are not found persuasive because the requirement pertaining to undue burden applies to Restriction in application filed under 35 U.S.C. 111, however the current application has been submitted under 35 U.S.C. 371 and thus follows a Unity of Invention analysis rather than the independent and distinct analysis followed for applications filed under 35 U.S.C. 111. The requirements for unity of invention can be found in MPEP Section 1850. Analysis of Unity of Invention in the Restriction/Election requirement mailed on December 29th, 2025 is found to be sufficient to show an “a posteriori” lack of unity as the link between the independent claims of the current application has been shown to have been known by the prior art and thus a lack of unity “a posteriori” is seen to have been properly identified. As such the restriction requirement is herein maintained and the election of Group II for examination recorded.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-15 are currently pending. In response to the requirement for Restriction/Election mailed on December 29th, 2025. Applicant has elected Group II, as such claims 4-8 and newly added claims 14-15 are currently under consideration. Claims 4 and 6-8 have been amended.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 line 4 states “to which negative pressure to be formed” should read –to which negative pressure is to be formed--. Appropriate correction is required.
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 4-8 and 14-15 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 4 recites the limitation "the first" in line 3 and “the second” in line 6. There is insufficient antecedent basis for this limitation in the claim as a first and a second have not been established prior in the claim limitations and as such it is unclear to what object “the first” and “the second” are referring to. For the purpose of examination “the first” and “the second” are being to interpreted to mean –a first set—and –a second set—respectively.
Claim 4 recites the limitation "a body" in lines 3 and 6. It is unclear as to whether these limitations are the same body or separate bodies. For the purpose of examination “a body” in line 3 and “a body” in line 6 are being to interpreted to mean –a first body—and –a second body— respectively.
Claim 4 recites the limitation "the value" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “at least one body” and “at least one plunger” in lines 1 and 2. It is unclear as to whether this is the same body and plunger as recited in claim 4 from which claim 5 depends or a separate body and plunger.
Claim 5 recites the limitation “an internal region of the body”, it is unclear as to whether this is the same internal region as recited in claim 4 from which claim 5 depends or a separate internal region.
Claim 5 recites “at least one channel” in line 4, it is unclear as to whether this is the same channel as introduced in claim 4 or a separate channel.
Claim 5 recites “the internal region of the first plunger” in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination this is being interpreted to be –the internal region of the body—as the specification does not appear to provide any delineation of what would constitute an internal region of the first plunger.
Claim 5 recites “at least one indication mechanism” in line 6. it is unclear as to whether this is the same indication mechanism as introduced in claim 4 or a separate indication mechanism.
Claim 5 recites “at least one visual indicator” in line 7. it is unclear as to whether this is the same visual indicator as introduced in claim 4 or a separate visual indicator.
Claim 7 recites “the elastic element” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “the length direction” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 6, 8, and 15 are rejected based on their dependency upon rejected claim 4.
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 4 recites the limitation of “means of” as well as the functional language of “indicated” and the structural limitation of “visual indicator”. This claim includes the limitation of “means” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. The claim limitation of “visual indicator” is seen to provide sufficient structure to accomplish a means by which to indicate a negative pressure value.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taheri (U.S. Publication 2007/0009584).
Regarding claim 4, Taheri discloses a device (Fig. 10a-d) for manual generation (Title manually operable depressurization system;) and indication (¶0010 apparatus may further include a pressure gauge to measure air pressure delivered by the vacuum generator) of negative pressure in a dressing (¶0009 negative air pressure to the dressing and wound) characterized in that it comprises at least two sets (324 and pressure gage:
the first containing a body (barrel of syringe 324 as seen in Fig. 4) connectable (connectable through tubing as illustrated in Fig. 4) to an auxiliary structure 304 to which negative pressure is to be formed (¶0009 negative air pressure to the dressing and wound), and at least one first plunger (Fig. 4 plunger inside syringe barrel) manually operable and arranged in a sliding manner in an internal region of the body (¶0049 syringe plunger is slid in and out to create positive and negative pressure); and
the second containing a body (pressure gauge body) fixedly connected to the first plunger through at least one channel communicating with the internal region of the body (pressure gauge measures air pressure delivered by the pressure/vacuum generator and is thus in communication with the fluid pathway which includes the internal region of the body to which the plunger acts to generate the negative pressure, Fig. 1 shows how the pressure gauge is connected to the vacuum communicating line in a fixed manner and thus is fixedly connected to the first plunger through its connection to the fluid communication lines) and at least an indication mechanism (Fig. 1 shows line of pressure gauge that would indicated the measured pressure) of negative pressure arranged with the channel (arranged with the pressure gauge which is arranged with the channel to which the pressure gauge initiates communication with the vacuum space),
the value of the negative pressure being indicated by means of at least one visual indicator (Fig. 1 shows visual arrow of pressure gauge) according to the manual activation of the first plunger (pressure gauge is activated based on the activation of negative pressure on the system which is caused by activation of the first plunger and thus according to activation of the first plunger).
Regarding claim 15, Taheri discloses the device according to claim 4. Taheri further discloses the visual indicator comprising a geometric indicator (Fig. 1 shows line of pressure gauge that would indicate the measured pressure, a line constitutes a geometric indicator).
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(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taheri (U.S. Publication 2007/0009584) in view of Harle (U.S. Patent No. 4,373,528) and further in view of Enk (U.S. Patent No. 6,086,559).
Regarding claims 5, Taheri discloses the device (Fig. 10a-d) according to claim 4.
Taheri does not expressly disclose the at least one channel extending along the length of the first plunger, the at least one indication mechanism being arranged internally to the channel, the at least one visual indicator associated with the channel, or the indication mechanism moving along the inner part of the channel to measure the negative pressure value.
However, Harle, in the same field of endeavor of measuring negative pressure applied to wounds (Abstract evacuating secretions from wounds; Fig. 5 depicts negative pressure measurement device), teaches a first body (1) of a first set (1) and a second body (5) of a second set (5) wherein the second body (5) is fixedly connected to the first body (scale bearer fixedly arranged at top side of the suction bottle 1) through at least one channel (channel 10 comprises element 26 that accomplishes attachment as seen in Fig 2 detailed in Fig. 5) communicating with the internal region of the body (communicates through internally positioned enclosure 7 through opening 6) and at least an indication mechanism (8 moves up and down along scale in accordance with value of negative pressure to indicated the negative pressure) of negative pressure arranged internally to the channel (arranged internal to channel) that moves along the inner part of the channel to measure a negative pressure value (Col. 3 lines 22-28 when there is no vacuum present in the bottle holds the abutment 8 in its upper position. If a vacuum does prevail then this vacuum strives to draw the abutment downwardly toward the pressure opening and, indeed, against the action of the return spring; this shows stretch and contraction based on vacuum), wherein the second set indicates a value of the negative pressure by means of a visual indicator (scale present on element 10) according to the activation of negative pressure in the system (Col. 3 lines 22-28 when there is no vacuum present in the bottle holds the abutment 8 in its upper position. If a vacuum does prevail then this vacuum strives to draw the abutment downwardly toward the pressure opening and, indeed, against the action of the return spring; this shows stretch and contraction based on vacuum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second set of Taheri that performs the function of measuring a pressure in a negative pressure environment with the second set of Harle since these elements perform the same function of providing a measurement of vacuum in a negative pressure distributing system. Simply substituting one negative pressure measurement means for another would yield the predictable result of allowing a(n) negative pressure to be measured. See MPEP 2143.
Taheri in view of Harle do not expressly disclose the at least one channel extending along the length of the first plunger.
However, Enk, in the same field of endeavor of measuring negative pressure of a syringe based system (Col. 12 lines 22-35 measurement of negative pressure is also possible), teaches providing a channel (2e) communicating (communicates through aperture 2f) with the internal region (region containing fluid 4a or gas 4b) of a first body (1a) that extends along the length of a first plunger (2a) of a syringe (1a and 2a in combination).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the second set of Taheri in view of Harle to extend along the length of the first plunger and communicate with the internal cavity through the plunger, as taught by Enk, since this claimed position of second set does not change the second set’s ability to measure pressure provided by the negative pressure source in the system. Since applicant has not given any criticality to why the position of the measurement channel disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In the instant case, the second set of Taheri in view of Harle performs the same function as claimed by Applicant of measuring a negative pressure within a negative pressure providing system and rearranging the second set to extend along the length of the first plunger, as taught by Enk, would not have changed the second set’s ability to measure the negative pressure within the system and thus would continue to perform the same function. As such the claim limitation requiring the second set to extend along the length of the first plunger is patently undistinguishable from the prior art as compared with the device suggested by Taheri in view of Harle and Enk.
Furthermore, one of ordinary skill in the art would have been motivated to perform the rearrangement of the second set of Taheri in view of Harle, to be positioned in the manner taught by Enk for the purpose of including the negative pressure measurement device with the syringe (Col. 4 lines 23-32, in an advantageous embodiment, the syringe is provided with a pressure measuring means) which would have the added benefit of including both the negative pressure source and the syringe together such that a separate measuring device is not required.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taheri (U.S. Publication 2007/0009584) in view of Harle (U.S. Patent No. 4,373,528).
Regarding claims 6-8 and 14, Taheri discloses the device according to claim 4. Taheri does not expressly disclose the indication mechanism being fixed to an elastic element, the elastic element being fixed to a first end of the inner part of the channel by means of at least one flap, the elastic element extending along the length of the channel.
However, Harle, in the same field of endeavor of measuring negative pressure applied to wounds (Abstract evacuating secretions from wounds; Fig. 5 depicts negative pressure measurement device), teaches a first body (1) of a first set (1) and a second body (5) of a second set (5) wherein the second body (5) is fixedly connected to the first body (scale bearer fixedly arranged at top side of the suction bottle 1) through at least one channel (channel 10 comprises element 26 that accomplishes attachment as seen in Fig 2 detailed in Fig. 5) communicating with the internal region of the body (communicates through internally positioned enclosure 7 through opening 6) and at least an indication mechanism (8 moves up and down along scale in accordance with value of negative pressure to indicated the negative pressure) of negative pressure arranged with the channel (arranged internal to channel) wherein the indication mechanism is fixed to an elastic element 9 comprising a spring (see Fig. 3 element 9) (Claim 6) fixed (secured between elements 14 and 17 and thus fixed at this location between these ends) to a first end (end at which element 12 resides) by means of at least one flap (flaps 14 and 17; fixed by means of placement between elements 14 and 17), the elastic element extending along the length of the channel (Fig. 1 shows extension of spring along length of channel) (Claim 7), wherein the channel comprises two environments (environment internal to sealing member 7 and environment outside of sealing member 7) separated and isolated by the indication mechanism (element 16 of indication mechanism 8 attaches to sealing member 7 to close off and thus separate the environments), the two environments including a first environment with at least one first end with the flap 12 being hollow (hollow through annular rim 15 to element 6) for air intake from the internal environment of the suction dressing (6 opens to internal vacuum environment) and a second environment (environment external to sealing member 7)with at least one second end (end of element 10 opposite to element 12) hollow for atmospheric air intake (Fig. 1 shows second end open to external environment and thus atmospheric air) in which the elastic element stretches and contracts along the channel (Col. 3 lines 22-28 when there is no vacuum present in the bottle holds the abutment 8 in its upper position. If a vacuum does prevail then this vacuum strives to draw the abutment downwardly toward the pressure opening and, indeed, against the action of the return spring; this shows stretch and contraction based on vacuum) (Claim 8) wherein the second set indicates a value of the negative pressure by means of a visual indicator (scale present on element 10) according to the activation of negative pressure in the system (Col. 3 lines 22-28 when there is no vacuum present in the bottle holds the abutment 8 in its upper position. If a vacuum does prevail then this vacuum strives to draw the abutment downwardly toward the pressure opening and, indeed, against the action of the return spring; this shows stretch and contraction based on vacuum), the visual indicator being arranged parallel to the length direction of the channel (marks are arranged in a graduated manner extending parallel to the length of the channel of 10) (Claim 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second set of Taheri that performs the function of measuring a pressure in a negative pressure environment with the second set of Harle since these elements perform the same function of providing a measurement of vacuum in a negative pressure distributing system. Simply substituting one negative pressure measurement means for another would yield the predictable result of allowing a(n) negative pressure to be measured. See MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DeRogatis (U.S. Patent No. 4,222,276) discloses a pressure gauge utilizing a spring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 1 May 2026
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