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 .
Response to Amendment
In response to the amendment filed on 02/04/2026, No Claims have been cancelled, and Claims 1-10 are pending.
Response to Arguments
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive.
Applicant asserts that Sharma fails to disclose a burstable membrane however the Examiner respectfully disagrees. While Sharma does indeed teach a check valve which is “burstable”, Sharma fails to teach that the check valve ruptures at a predetermined pressure.
However, Sharma does disclose “In preferred embodiments, a fluid chamber 400 contains fluid components are arranged in concentric subchambers 410, 420 sealed at their distal ends (i.e. the ends nearest the outlet of the delivery system) with a plastic membrane. The membrane seal is broken by pressure which can be a user-operated actuator action such as a squeeze or push of the grey part shown in FIG. 25. In some embodiments, a check valve or a one way valve is utilized rather than a puncturable plastic membrane; the valve opens upon the application of pressure.” (Column 11, Lines 14-16).
Therefore, Sharama does indeed teach a first and second chamber sealed at their distal ends with a first/second burstable membranes configured to rupture at predetermined pressures. Furthermore, Sharma clearly teaches that the one way check valve and the puncturable plastic membranes are obvious variants.
Lastly, should Applicant disagree, Sullivan clearly teaches chambers for delivering a medicine through a nozzle, wherein the chambers comprise burstable membranes configured to rupture at predetermined pressures (Paragraph 0040).
For these reasons, the rejections of Sharma and Sullivan are being maintained.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma (US Patent 10,687,795) in view of Sullivan (US PGPub 2006/0276755).
Regarding Claim 1, Sharma teaches a medical device (Figure 1A-1B, Figure 39), comprising:
a first chamber (811; Figure 39) (110A; Figure 1A) containing a first composition (polyol; Figure 39), wherein the first chamber (811) is connected to a first valve (814) having a first burstable membrane (Column 13, Lines 19-24; the examiner notes that the term burstable is an intended use and the one-way valve taught by Sharma is configured to hold fluid therein and then the plunger allows fluid to burst through the membrane);
a second chamber (812; Figure 39) (110B; Figure 1A) containing a second composition (isocyanate), wherein the second chamber (812) is connected to a second valve (814) having a second burstable membrane (Column 13, Lines 19-24 states that each chamber has a the one way valve; furthermore the examiner notes that the term burstable is an intended use and the one-way valve taught by Sharma is configured to hold fluid therein and then the plunger allows fluid to burst through the membrane);
a converger (see annotated Figure 39, provided below) connected to the first valve (814) of the first chamber (811) and the second valve (814) of the second chamber (812), wherein the converger is configured to mix the first composition and the second composition to produce a reactive mixture that forms a solid (it’s the Examiner’s position that the converger is indeed configured to mix the compositions to produce a reactive mixture before going into the nozzle and whether it turns into a solid is dependent on the materials that are being mixed);
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a nozzle (840; Figure 38B) connected to the converger (as seen in Figure 38B) and configured to deliver the reactive mixture material to a patient (see Figure 38B).
Sharma teaches “In preferred embodiments, a fluid chamber 400 contains fluid components are arranged in concentric subchambers 410, 420 sealed at their distal ends (i.e. the ends nearest the outlet of the delivery system) with a plastic membrane. The membrane seal is broken by pressure which can be a user-operated actuator action such as a squeeze or push of the grey part shown in FIG. 25. In some embodiments, a check valve or a one way valve is utilized rather than a puncturable plastic membrane; the valve opens upon the application of pressure.” (Column 11, Lines 14-16). Therefore, Sharama does indeed teach a first and second chamber sealed at their distal ends with puncturable plastic membrane, however Sharma does not explicitly state that the embodiment of Figure 36 comprises a first and second burstable membrane configured to rupture at a first and second predetermined pressure.
Furthermore, Sullivan teaches a valved delivery device having a plurality of cartridges (chambers) carrying a medication therein (see Paragraph 0034), wherein each cartridge comprises a burstable membrane (86; Paragraph 0034) configured to burst a predetermined pressures (0040).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify the burstable membranes of Sharma using the materials as taught by Sullivan, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; Sharma teaches that a puncturable membrane would be sufficient to provide the fluid components to the nozzle and Sharma teaches that a puncturable membrane is an obvious variant mechanism for sealing the end of the chambers (Column 11, Lines 14-16).
Regarding Claim 2, the combination of references disclosed above teaches the medical device of claim 1, wherein Sharma and Sullivan teach the burstable membrane (814) of the first valve and the second valve are configured to prevent gas diffusion from a gas source to an interior of the converger, or from an interior of the converger to a gas source (Column 13, Lines 21-32; Sharma) (Paragraph 0016 and 0043; Sullivan).
Regarding Claim 3, the combination of references disclosed above teaches the medical device of claim 2, wherein Sharma teaches the gas source includes water vapor (the Examiner notes that the gas source is not positively recited in Claim 2 and therefore the claim only requires that the gas source be capable of being water vapor and it’s the Examiner’s position that there is nothing preventing the aerator to be water vapor, even if it’s just air the air naturally has humidity which would include water vapor; but most importantly, the gas source is not positively recited in the claims).
Regarding Claim 4, the combination of references disclosed above teaches the medical device of claim 1, wherein Sharma teaches the first composition (811) comprises a polyol (Figure 39).
Regarding Claim 5, the combination of references disclosed above teaches the medical device of claim 1, wherein Sharma teaches the second composition (812) comprises an isocyanate (Figure 39).
Regarding Claim 6, the combination of references disclosed above teaches the medical device of claim 1, wherein Sullivan teaches wherein each cartridge comprises a burstable membrane (86; Paragraph 0034), wherein the burstable membrane (86) of the first valve and the second valve is a polypropylene membrane (Paragraph 0040).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify the burstable membrane of Sharma using the materials as taught by Sullivan, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 7, the combination of references disclosed above teaches the medical device of claim 1, wherein Sullivan teaches wherein each cartridge of the first and second predetermined pressures are about 45 psi (3.06atm). See Paragraph 0040 which discloses that the burst pressure is between 1.2 atm to 10 atm, preferably less than 5 atm and most preferably between 1.5 atm and 4 atm. The range 1.5 atm to 4 atm encompasses the claimed pressure of 45 psi or 3.06 atm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the burst pressure of Sharma to be about 45 psi as taught by Sullivan, since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 8, the combination of references disclosed above teaches the medical device of claim 1, wherein Sullivan teaches wherein the burstable membrane of the first valve and the second valve is about .3ml to 1.5 mil (Paragraph 0040; which equates to 7.62 microns to 38.1 microns). Furthermore, Sullivan teaches that films can be tailored to provide an appropriate burst pressure within a preferred thickness range (Paragraph 0014).
Given that the thickness of the film is tailored to the appropriated burst pressure, it would have been obvious to one of ordinary skill in the art to optimize the thickness of the burstable membrane through routine experimentation in order to achieve a desirable burst strength for the burstable membrane. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Applicant has not provided evidence of the criticality of the claimed ranges in the instant specification. In Paragraph 0031 of the instant invention PGPub, Applicant lists various ranges of the thickness of the membrane but fails to discloses the purpose of the criticality for the claimed range of 1-5 microns. Paragraph 0031 states that the membrane can be 1-12 microns thick and “without limitation, the membrane can be about 4 microns thick. In some embodiments, the membrane 228 may be less than about 1 μm thick or greater than 10 μm thick.” (see Paragraph 0031 if instant application PGPub). It is the Examiner's position that since there is a lack of criticality/reasoning for the particular claimed range, and the range of thickness of the burstable membrane of the combination of references is to achieve the same purpose as Applicant’s purpose (to burst at a particular pressure and allow for fluid to flow through and then return to normal operation; see Paragraph 0031 of instant specification PGPub), it would have been obvious to one skilled in the art to modify the combination of prior art references claimed above to the claimed range of thickness of the burstable membrane since this is a mere obvious design choice that fails to patentably distinguish the invention of claim 8 from the prior art.
Regarding Claim 9, the combination of references disclosed above teaches the medical device of claim 1, wherein Sharma teaches the reactive mixture comprises an elastomeric polyurethane (Column 1, Lines 57-60).
Regarding Claim 10, the combination of references disclosed above teaches the medical device of claim 1, wherein Sharma teaches the reactive mixture reacts in a body cavity of the patient to generate a gas, thereby forming a polymer formulation (Column 1, Lines 60-67 and Column 2, Lines 1-2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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