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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/26/2026 has been entered.
Response to Amendment
Applicant has amended claims 1, 3, 4, 18, 27, and 29. Claims 1-30 remain pending.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities:
Claims 1 and 18 appear to have redundancies where they each recite “a non-spring compression member mechanism”. It appears that the term “member mechanism” is redundant, and that the claims should either refer to “a non-spring compression member” or “a non-spring compression mechanism”.
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 non-spring compression member mechanism configured to prevent the plunger in the buffer compartment from moving outward” in claims 1, 18, 27, and 29.
These limitations use terms which do not denote any specific structures (mechanism is a nonce term), are limited by functional language (configured to prevent the plunger from moving outward), and lack specific further structures (noting especially that “a non-spring compression member” does not denote any specific structure, and only serves to limit on which structures are equivalents), thus leading to the interpretations under 35 U.S.C. 112(f).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-30 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.
The term “substantially” in claims 29-30 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear if the anesthetic is meant to be an exact numerical value of osmolality (308 mOsm/L as in claim 30), or is meant to be substantially equal to that osmolality value. For the purposes of compact prosecution and in keeping with Applicant’s Specification at [0065] which teaches that the target range is from 200-416 mOsm/L, it appears as though the exact numerical value is not critical, and thus the claim is understood to require an osmolality which is substantially similar to 308 mOsm/L – since no basis is given for what is meant to be substantial equivalence, this is understood to be +/- 5% of 308 mOsm/L.
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.
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) 1-6, 8-11, 14-15, 17-20, and 25-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stepovich et al. (US 20090292271, henceforth Stepovich, previously made of record) in view of Franke et al. (US 20200397999, henceforth Franke).
Regarding claim 1, Stepovich discloses a device (device 10, fig. 1) comprising: a buffer compartment (housing 14, fig. 1) comprising a plunger (plunger 58, fig. 3) and containing a buffer (see [0038], buffer cartridge 16 contains buffer); an anesthetic compartment (receptacle region 44, fig. 3) configured to receive an anesthetic cartridge ([0037], the anesthetic cartridge is 28; Examiner notes that the anesthetic cartridge is not positively recited and the device is only required to be functionally capable of use with an anesthetic cartridge as claimed; the anesthetic cartridge and features thereof called out here are for illustrative purposes to demonstrate the claimed functionality of the claimed device) the anesthetic cartridge comprising a first end (the end where neck 32 is shown is the first end, see fig, 1) comprising a septum (septum end 32 of cartridge 28, fig. 6, is understood to have a septum which is why it is the septum end) and containing an anesthetic (see [0043], anesthetic cartridge 28 has anesthetic in it); a needle assembly (needles 36 and 38, fig. 5) comprising a transfer needle (transfer needle 36, fig. 5) having a first end (proximal end 50, fig. 5) and a second end (distal end 40, fig. 5), wherein the second end of the needle is configured to penetrate the septum of the anesthetic cartridge (see fig. 6); and a mechanism (pusher 20, spring 18, stop member 62, and window 64 make up the claimed mechanism) configured to prevent the plunger in the buffer compartment from moving outward (the called out mechanism prevents plunger 58 from moving proximally outward from the device where it keeps plunger 58 moving distally during use, see at least [0041] and [0042]). Stepovich additionally discloses that the mechanism can comprise a spring or equivalent compression member (see at least [0022], [0024], or [0026]).
Stepovich does not disclose that the mechanism is a non-spring compression member mechanism. Franke teaches a mechanism in which a spring can be compressed where the spring and an elastomer can be replaced with each other and are equivalents ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the spring of Stepovich with an elastomer as in Franke since Stepovich discloses that the compressible material can be a spring or an equivalent member (see at least [0022], [0024], and [0026]) and since Franke teaches a spring and an elastomer to be equivalent compressible materials used for storing energy ([0040]), and because such a substitution would have yielded the same, predictable result of a mechanism which functions to prevent the plunger in the buffer compartment from moving outward as claimed.
Regarding claim 2, Stepovich as modified by Franke (henceforth Stepovich as modified) discloses the device of claim 1 wherein the plunger is located completely within the buffer compartment (see fig. 6, housing 14 completely surrounds plunger 58).
Regarding claim 3, Stepovich discloses the device of claim 1 wherein the non-spring compression member mechanism is further configured to prevent gas from leaving solution in the buffer (see [0041] and [0042], advancement of pusher 20 pushes the contents of cartridge 16 only into cartridge 28 and thus is configured to prevent has from leaving solution as claimed since it only allows for proximal advancement of plunger 58; note also that [0041] of Stepovich is understood to have a typographical error where it refers to anesthetic cartridge 16).
Regarding claim 4, Stepovich discloses the device of claim 1 wherein the non-spring compression member mechanism is further configured to not allow the plunger to displace outward if carbon dioxide evolves out of solution (the called out mechanism prevents plunger 58 and pusher 20 from displacing outward in the proximal direction under all circumstances as disclosed in [0041]).
Regarding claim 5, Stepovich discloses the device of claim 1 wherein the buffer compartment is proximal to a first end of the device (the claimed first end of the device is the threaded portion of housing 14 which connects to knob 12 as shown in fig. 5 and the proximal direction points from cartridge 28 towards cartridge 16 in fig. 6; housing 14 exists in this proximal direction from this first end) and the anesthetic compartment is proximal to a second end of the device (the claimed second end of the device is the end of knob 12 which is furthest from pusher 20 as shown in fig. 6; receptacle region 44 is proximal to this distal most end as claimed).
Regarding claim 6, Stepovich discloses the device of claim 1 wherein the buffer compartment is substantially cylindrical (see figs. 1 and 2, housing 14 is shown as being hollow and tube-shaped, or cylindrical as claimed).
Regarding claim 8, Stepovich discloses the device of claim 1 wherein the buffer is a sodium bicarbonate solution ([0015]).
Regarding claim 9, Stepovich discloses the device of claim 8 wherein the buffer is 8.4% sodium bicarbonate in aqueous solution ([0015]).
Regarding claim 10, Stepovich discloses the device of claim 8 wherein the buffer is in a stable condition with minimal pH change (see [0015], since pH is maintained it is considered to be in stable condition with minimal change, see also [0017]) and carbon dioxide loss prior to use ([0017]).
Regarding claim 11, Stepovich discloses the device of claim 10 wherein the buffer is pressurized to inhibit evolution of carbon dioxide ([0024] and [0025]).
Regarding claim 14, Stepovich discloses the device of claim 1 wherein the anesthetic compartment comprises an open end distal to the buffer compartment (see fig. 3, receptacle region 44 is an open end as claimed).
Regarding claim 15, Stepovich discloses the device of claim 14 wherein the open end is configured for the anesthetic cartridge to be inserted into the device by placing the anesthetic cartridge into the open end (see figs. 3 and 6).
Regarding claim 17, Stepovich discloses the device of claim 1 wherein the transfer needle provides a fluid path between the buffer compartment and the anesthetic cartridge ([0014]).
Regarding claim 18, Stepovich discloses a method, comprising: providing a device (device 10, fig. 1) comprising: a buffer compartment (device 10, fig. 1) comprising a plunger (plunger 58, fig. 3) and containing a buffer (see [0038], buffer cartridge 16 contains buffer); an anesthetic compartment (receptacle region 44, fig. 3) configured to receive an anesthetic cartridge ([0037], the anesthetic cartridge is 28; Examiner notes that the anesthetic cartridge is not positively recited and the device is only required to be functionally capable of use with an anesthetic cartridge as claimed; the anesthetic cartridge and features thereof called out here are for illustrative purposes to demonstrate the claimed functionality of the claimed device) comprising a septum (septum end 32 of cartridge 28, fig. 6, is understood to have a septum which is why it is the septum end) and containing an anesthetic (see [0043], anesthetic cartridge 28 has anesthetic in it); a needle assembly (needles 36 and 38, fig. 5) comprising a transfer needle (transfer needle 36, fig. 5) having a first end (proximal end 50, fig. 5) and a second end (distal end 40, fig. 5); a mechanism (pusher 20, spring 18, stop member 62, and window 64 make up the claimed mechanism) configured to prevent the plunger in the buffer compartment from moving outward (the called out mechanism prevents plunger 58 from moving proximally outward from the device where it keeps plunger 58 moving distally during use, see at least [0041] and [0042]); inserting the anesthetic cartridge ([0037], the anesthetic cartridge is 28), comprising the septum (septum end 32 of cartridge 28, fig. 6, is understood to have a septum which is why it is the septum end) and containing the anesthetic (see [0043], anesthetic cartridge 28 has anesthetic in it), into the anesthetic compartment (see fig. 6, cartridge 28 is inserted into receptacle region 44 as claimed); causing the second end of the transfer needle to penetrate the septum (see fig. 6) and the plunger to be moved into the buffer compartment (see figs. 6 and 7, plunger 58 moves distally further into housing 14 during use), whereby; buffer is transferred from the buffer compartment via the transfer needle into the anesthetic cartridge ([0043]). Stepovich additionally discloses that the mechanism can comprise a spring or equivalent compression member (see at least [0022], [0024], or [0026]).
Stepovich does not disclose that the mechanism is a non-spring compression member mechanism. Franke teaches a mechanism in which a spring can be compressed where the spring and an elastomer can be replaced with each other and are equivalents ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the spring of Stepovich with an elastomer as in Franke since Stepovich discloses that the compressible material can be a spring or an equivalent member (see at least [0022], [0024], and [0026]) and since Franke teaches a spring and an elastomer to be equivalent compressible materials used for storing energy ([0040]), and because such a substitution would have yielded the same, predictable result of a mechanism which functions to prevent the plunger in the buffer compartment from moving outward as claimed.
Regarding claim 19, Stepovich discloses the method of claim 18 further comprising: withdrawing the anesthetic cartridge from the device (see [0019], multiple anesthetic cartridges can be used sequentially, meaning the first anesthetic cartridge is removed from the device).
Regarding claim 20, Stepovich discloses the method of claim 18 wherein the method comprises compounding an anesthetic medication (see [0003] and [0010], the combining of buffer with anesthetic is a compounding of medication as claimed).
Regarding claim 25, Stepovich discloses the method of claim 18 wherein the buffer is a sodium bicarbonate solution ([0015]).
Regarding claim 26, Stepovich discloses the method of claim 25 wherein the buffer is 8.4% sodium bicarbonate in aqueous solution ([0015]).
Regarding claim 27, Stepovich discloses a method, comprising: providing a device (device 10, fig. 1) comprising; a buffer compartment (housing 14, fig. 1) comprising a plunger (plunger 58, fig. 3) and containing a buffer (see [0038], buffer cartridge 16 contains buffer); an anesthetic compartment (receptacle region 44, fig. 3) configured to receive an anesthetic cartridge ([0037], the anesthetic cartridge is 28; Examiner notes that the anesthetic cartridge is not positively recited and the device is only required to be functionally capable of use with an anesthetic cartridge as claimed; the anesthetic cartridge and features thereof called out here are for illustrative purposes to demonstrate the claimed functionality of the claimed device) comprising an end (septum end 32, fig. 6) that comprises a septum (septum end 32 of cartridge 28, fig. 6, is understood to have a septum which is why it is the septum end) and containing an anesthetic (see [0043], anesthetic cartridge 28 has anesthetic in it); a needle assembly (needles 36 and 38, fig. 5) comprising a transfer needle (transfer needle 36, fig. 5) having a first end (proximal end 50, fig. 5) and a second end (distal end 40, fig. 5); a mechanism (pusher 20, spring 18, stop member 62, and window 64 make up the claimed mechanism) configured to prevent the plunger in the buffer compartment from moving outward (the called out mechanism prevents plunger 58 from moving proximally outward from the device where it keeps plunger 58 moving distally during use, see at least [0041] and [0042]); inserting the anesthetic cartridge into the anesthetic compartment (see fig. 6, cartridge 28 is inserted into receptacle region 44 as claimed), wherein the second end of the transfer needle penetrates the septum (see fig. 6); causing movement of the plunger into the buffer compartment (see figs. 6 and 7, plunger 52 moves further distally into housing 14 as shown) to expel buffer from the buffer cartridge into the anesthetic cartridge via the transfer needle ([0043]). Stepovich additionally discloses that the mechanism can comprise a spring or equivalent compression member (see at least [0022], [0024], or [0026]).
Stepovich does not disclose that the mechanism is a non-spring compression member mechanism. Franke teaches a mechanism in which a spring can be compressed where the spring and an elastomer can be replaced with each other and are equivalents ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the spring of Stepovich with an elastomer as in Franke since Stepovich discloses that the compressible material can be a spring or an equivalent member (see at least [0022], [0024], and [0026]) and since Franke teaches a spring and an elastomer to be equivalent compressible materials used for storing energy ([0040]), and because such a substitution would have yielded the same, predictable result of a mechanism which functions to prevent the plunger in the buffer compartment from moving outward as claimed.
Regarding claim 28, Stepovich discloses the method of claim 27 further comprising withdrawing the anesthetic cartridge from the device (see [0019], multiple anesthetic cartridges can be used sequentially, meaning the first anesthetic cartridge is removed from the device).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stepovich et al. (US 20090292271, henceforth Stepovich, previously made of record) in view of Franke et al. (US 20200397999, henceforth Franke) as applied to claim 1 above, and further in view of Erickson (US Pat. No. 5603695, henceforth Erickson, previously made of record).
Regarding claim 7, Stepovich discloses the device of claim 1.
Stepovich is silent as to the materials used in the device and thus does not disclose that the device comprises plastic. Erickson teaches a device (cartridge 10, fig. 1) to be used with anesthetic (Col. 1 lines 4-6) configured for buffering an anesthetic cartridge (Col. 1 lines 38-47) which comprises plastic (Col. 2 lines 44-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the device of Stepovich out of plastic as in Erickson to allow the device to be disposable (see Erickson Col. 1 lines 38-47) and to allow for ease of use (Col. 1 lines 56-61).
Claim(s) 12-13 and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stepovich et al. (US 20090292271, henceforth Stepovich, previously made of record) in view of Franke et al. (US 20200397999, henceforth Franke) as applied to claims 1 and 18 above as evidenced by Berchtold et al. (Berchtold JF, Constable PD, Smith GW, Mathur SM, Morin DE, Tranquilli WJ. Effects of intravenous hyperosmotic sodium bicarbonate on arterial and cerebrospinal fluid acid-base status and cardiovascular function in calves with experimentally induced respiratory and strong ion acidosis. J Vet Intern Med. 2005 Mar-Apr;19(2):240-51., henceforth Berchtold) and further in view of Eggers et al. (US 20030225401, henceforth Eggers) and Klement et al. (Klement W, Arndt JO. Pain on i.v. injection by some anaesthetic agents is evoked by the unphysiological osmolality or pH of their formulations. British Journal of Anaesthesia. 1991; 66: 189-195., henceforth Klement).
Regarding claims 12 and 21, Stepovich discloses the device of claim 1 and the method of claim 18 wherein the buffer is 8.4% aqueous sodium bicarbonate solution ([0015]).
Stepovich does not explicitly disclose that the buffer is hyperosmotic when compared to the osmolarity of human blood or tissues. Berchtold evidences that buffer which is 8.4% aqueous sodium bicarbonate, which is the buffer of Stepovich, is hyperosmotic (see Abstract) having an osmolarity of 2,000 mOsm/L (see pg. 240, second column, first paragraph).
Stepovich additionally discloses that the buffering of anesthetics is done to create stable chemical compositions with stable pHs ([0013]) and that the combination of the buffer and the anesthetic creates this desired chemical profile ([0013]).
Stepovich does not explicitly disclose that the anesthetic is hypoosmotic when compared to the osmolarity of human blood or tissues. Eggers teaches that anesthetics need to be diluted to create desirable osmolarity prior to injection ([0022]) where the desirable osmolarity is in the range of 240-340 mOsm/L ([0022]), especially where cellular fluids and plasma have an osmolarity of 310 mOsm/L ([0022]). Klement teaches that injection of anesthetics with pHs and osmolalities which are outside of a physiological range causes pain (see Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the anesthetic of Stepovich hypoosmotic since the buffer is hyperosmotic and a mixture of the two solutions could then yield a resultant solution which is in the desired range of osmolality (isosmotic with cellular fluids and plasma) such as to avoid the pain associated with injection of a solution which is beyond the physiological range of osmolalities (see Klement Abstract) and to minimize the possibility of nerve injury and provide for safe injections (see Eggers [0022]).
Regarding claim 13, Stepovich as modified discloses the device of claim 12 wherein after compounding the buffer and the anesthetic, the combined solution is isosmotic (see the rejection of claim 12 above).
Regarding claim 22, Stepovich as modified discloses the method of claim 21 wherein after expelling the buffer into the anesthetic cartridge via the transfer needle, the solution is isosmotic (see the rejection of claim 21 above).
Regarding claim 23, Stepovich as modified discloses the method of claim 21 wherein after expelling the buffer into the anesthetic cartridge via the transfer needle, the combined solution is in a target range of osmolarity (see the rejection of claim 21 above).
Regarding claim 24, Stepovich as modified discloses the method of claim 21 wherein when the buffer and anesthetic are combined, the combined solution is an intended target osmolarity (see the rejection of claim 21 above).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stepovich et al. (US 20090292271, henceforth Stepovich, previously made of record) in view of Franke et al. (US 20200397999, henceforth Franke) as applied to claim 1 above, and further in view of Johnson et al. (US 20190184103, henceforth Johnson).
Regarding claim 16, Stepovich discloses the device of claim 1. Stepovich additionally discloses that its device can be used for dental applications ([0013]) with conventional anesthetic cartridges ([0013]).
Stepovich does not disclose that the anesthetic cartridge has an interior volume of 1.7 ml, 1.8 ml, or 3 ml. Johnson teaches that 1.7 mL is a conventional size of dental ampules ([0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the anesthesia cartridge to be 1.7 mL as claimed as Johnson teaches that 1.7 mL anesthesia cartridges are well known to be used in conventional dental procedures ([0047]) and because using such a size of anesthesia cartridge would have yielded the same, predictable result of an anesthesia cartridge which is usable for dental use and which can be buffered by the device of Stepovich.
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stepovich et al. (US 20090292271, henceforth Stepovich, previously made of record) as evidenced by Berchtold et al. (Berchtold JF, Constable PD, Smith GW, Mathur SM, Morin DE, Tranquilli WJ. Effects of intravenous hyperosmotic sodium bicarbonate on arterial and cerebrospinal fluid acid-base status and cardiovascular function in calves with experimentally induced respiratory and strong ion acidosis. J Vet Intern Med. 2005 Mar-Apr;19(2):240-51., henceforth Berchtold) in view of Eggers et al. (US 20030225401, henceforth Eggers), Klement et al. (Klement W, Arndt JO. Pain on i.v. injection by some anaesthetic agents is evoked by the unphysiological osmolality or pH of their formulations. British Journal of Anaesthesia. 1991; 66: 189-195., henceforth Klement), and Franke et al. (US 20200397999, henceforth Franke).
Regarding claim 29, Stepovich discloses a method for preparing an anesthetic, comprising: providing a device (device 10, fig. 1) comprising; a buffer compartment (housing 14, fig. 1) comprising a plunger (plunger 58, fig. 3) and containing a buffer (see [0038], buffer cartridge 16 contains buffer); an anesthetic compartment (receptacle region 44, fig. 3); a needle assembly (needles 36 and 38, fig. 5) comprising a transfer needle (transfer needle 36, fig. 5) having a first end (proximal end 50, fig. 5) and a second end (proximal end 50, fig. 5); a mechanism (pusher 20, spring 18, stop member 62, and window 64 make up the claimed mechanism) configured to prevent the plunger in the buffer compartment from moving outward (the called out mechanism prevents plunger 58 from moving proximally outward from the device where it keeps plunger 58 moving distally during use, see at least [0041] and [0042]); inserting an anesthetic cartridge (cartridge 28, fig. 6), comprising a septum (septum end 32 of cartridge 28, fig. 6, is understood to have a septum which is why it is the septum end) and containing an anesthetic (see [0043], anesthetic cartridge 28 has anesthetic in it) into the anesthetic compartment (see fig. 6, cartridge 28 is inserted into receptacle region 44 as claimed); causing the second end of the transfer needle to penetrate the septum (see fig. 6) and the plunger to be moved into the buffer compartment (see figs. 6 and 7, plunger 52 moves further distally into housing 14 as shown), whereby; buffer is transferred from the buffer compartment via the transfer needle into the anesthetic cartridge ([0043]). Stepovich additionally discloses that the buffer is 8.4% aqueous sodium bicarbonate solution ([0015]).
Stepovich does not explicitly disclose that the buffer is hyperosmotic when compared to the osmolarity of human blood or tissues. Berchtold evidences that buffer which is 8.4% aqueous sodium bicarbonate, which is the buffer of Stepovich, is hyperosmotic (see Abstract) having an osmolarity of 2,000 mOsm/L (see pg. 240, second column, first paragraph).
Stepovich additionally discloses that the buffering of anesthetics is done to create stable chemical compositions with stable pHs ([0013]) and that the combination of the buffer and the anesthetic creates this desired chemical profile ([0013]).
Stepovich does not explicitly disclose that the anesthetic is hypoosmotic. Eggers teaches that anesthetics need to be diluted to create desirable osmolarity prior to injection ([0022]) where the desirable osmolarity is in the range of 240-340 mOsm/L ([0022]), especially where cellular fluids and plasma have an osmolarity of 310 mOsm/L ([0022]). Klement teaches that injection of anesthetics with pHs and osmolalities which are outside of a physiological range causes pain (see Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the anesthetic of Stepovich hypoosmotic since the buffer is hyperosmotic and a mixture of the two solutions could then yield a resultant solution which substantially isosmotic as claimed (as compared with cellular fluids and plasma) such as to avoid the pain associated with injection of a solution which is beyond the physiological range of osmolalities (see Klement Abstract) and to minimize the possibility of nerve injury and provide for safe injections (see Eggers [0022]).
Stepovich additionally discloses that the mechanism can comprise a spring or equivalent compression member (see at least [0022], [0024], or [0026]).
Stepovich does not disclose that the mechanism is a non-spring compression member mechanism. Franke teaches a mechanism in which a spring can be compressed where the spring and an elastomer can be replaced with each other and are equivalents ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the spring of Stepovich with an elastomer as in Franke since Stepovich discloses that the compressible material can be a spring or an equivalent member (see at least [0022], [0024], and [0026]) and since Franke teaches a spring and an elastomer to be equivalent compressible materials used for storing energy ([0040]), and because such a substitution would have yielded the same, predictable result of a mechanism which functions to prevent the plunger in the buffer compartment from moving outward as claimed.
Regarding claim 30, Stepovich as modified discloses the method of claim 29 wherein substantially isosmotic is 310 mOsm/L (see the rejection of claim 29 above).
Stepovich as modified does not disclose the method of claim 29 where substantially isosmotic is 308 mOsm/L. However, due to the claim language requiring that the anesthetic is substantially isotonic, and because Applicant’s Specification demonstrates that “the target osmolarity is between 200 mOsm/L and 416 mOsm/L” and “substantially isosmotic at 308 mOsm/L”, the value of 308 mOsm/L is not considered to be critical or novel; additionally, the value of 310 in Stepovich as modified is substantially close to 308 as claimed, and thus Stepovich is considered to disclose the method where the resultant anesthetic is substantially equivalent to 308 mOsm/L as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Additionally, regarding the remaining rejection of claims 29 and 30 under 35 U.S.C. 112(b) for indefiniteness, Applicant has argued that the claims are not indefinite because the Specification makes clear that the exact numerical value is not critical, and that because Examiner has understood the claim to be +/- 5% of the claimed value, the claims are definite. Examiner notes that the value of 5% is not a set convention, and Applicant has not indicated this value to be indicative of what is meant by “substantially”. Further, the claims are still rendered indefinite in claim 30 where they appear to indicate an exact value of 308 mOsm/L after previously only requiring the anesthetic to be “substantially isosmotic”, and it is unclear if “substantially isosmotic” must be substantially equal to 308 mOsm/L, as if this is the case, then claim 30 is not further limiting on claim 29 on which it depends.
Conclusion
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
