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 .
Drawings
The drawings are objected to because of various informalities. In Fig. 3, it is unclear which elements of the filter media correspond to Figs. 1-2. For example, do the filter housings or the two layers on either side of the NaHCO3 correspond to porous surfaces of Figs. 1-2. Examiner suggests adding reference numerals to Fig. 3 for clarification, especially since Figs. 1-2 do not appear to have analogous filter housings. Figs. 4-11 appear to show various shape variations of the syringe cartridge, but it is unclear if these embodiments actually correspond to Figs. 1-2 or if they are completely different inventions altogether, especially given the absence of reference numerals.
The drawings are objected to as failing to properly use shading to aid in understanding the invention. 37 CFR 1.84(m) encourages the use of shading to indicate certain shapes or to show parts in
perspective views. However, in the instant case, the use of shading in at least Figs. 3-5, 7A, 7B, 9A, 9B, 11A, 11B, and 11C, is either unnecessary or reduces legibility by detracting from understanding the invention.
The drawings are objected to as failing to adequately use solid black lines. 37 CFR 1.84(a)(1) requires black ink to secure solid black lines and 37 CFR 1.84(l) states that every line must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 16 and 20 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 16 recites drawing the second drug up into the syringe and claim 20 similarly recites drawing up a diluent into the syringe. It is noted that the purpose of drawing up the second drug or diluent (herein referred to as the diluent) is to be mixed with the first drug which is within the syringe cartridge, not the syringe. Therefore, it is unclear why the diluent would be drawn into the syringe, when the first drug is actually located in the syringe cartridge, not the actual syringe. If the intention is to prefill the syringe prior to attachment to the syringe cartridge, such a limitation should be clearly defined in the claims, however claim 16 seems to clearly indicate the that drawing up initiates the mixing of the first drug and the diluent. Clarification is required.
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.
Claims 1, 4-7, 9, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 9,775,956 to Martin as evidenced by U.S. Patent Publication No 2006/0025355 to Duddu et al. (“Duddu”).
Regarding claim 1, Martin teaches a syringe cartridge (Figs. 1-5) comprising a body (10) having a proximal end (20), a distal end (18) opposed thereto, and an inner surface that defines an internal cavity (22), a male port (opening at 20) located at the proximal end and a female port (24) located at the distal end, wherein the male port is configured for engagement with a needle (14) and wherein the female port is configured for engagement with a syringe (I), a first porous surface (16) and a second porous surface (16) generally opposed thereto, wherein the first and the second porous surfaces are located within the internal cavity (Fig. 3), wherein the first porous surface is adjacent to the male port, and wherein the second porous surface is adjacent to the female port (Fig. 3), and (d) a predetermined quantity of a first drug (32) contained within the internal cavity in between the first porous surface and the second porous surface, and although Martin teaches the drug being in dry form (column 3, lines 19-20), Martin does not explicitly state the moisture content, although one of ordinary skill would understand that the a drug in dry form would have a moisture content of less than 5 wt% by virtue of being in a dry form.
In any case, Duddu has been cited as an evidentiary reference to teach that drugs in dry forms would have a moisture content of less than 5 wt% ([0120], less than about 0.5 wt%).
Regarding claim 4, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, Martin further teaching the body does not contain a spiral channel (Fig. 3, there is no spiral channel).
Regarding claim 5, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, Martin further teaching the male port is an outlet port (the drug goes through the port and out the needle) and the female port is an inlet port (24 receives fluid 34).
Regarding claim 6, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, Martin further teaching one or both of the first porous surface and the second porous surface is a filter (16 and 36 are defined as filters).
Regarding claim 7, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, Martin further teaching one or both of the first porous surface and the second porous surface is a fibrous insert (column 3, lines 63-67, Porex).
Regarding claim 9, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, the first drug having a moisture content of less than 1 wt% being previously evidenced by Duddu.
Regarding claim 14, Martin as evidenced by Duddu teaches a kit comprising the syringe cartridge of claim 1, and at least one of a syringe (I), a needle (14), and a predetermined quantity of a second drug (34).
Regarding claim 15, Martin as evidenced by Duddu teaches a syringe system comprising the syringe cartridge of claim 1, a needle (14), and a syringe (I), wherein the needle is connected to the male port and wherein the syringe is connected to the female port (Fig. 3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 3, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Martin as evidenced by Duddu.
Regarding claim 2, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, but does not mention the length of the body.
However, Hoasdlit would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the body of Martin to have a length of from about 20 mm to about 60 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Martin would not operate differently with the claimed body length, as this body length would be suitable for providing a sufficient length and therefore sufficient volume to hold and/or receive the first and/or second drug for mixing and subsequent delivery to the patient.
Regarding claim 3, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, but does not mention the body diameter.
However, Hoasdlit would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the body of Martin to have a maximum diameter of from about 10 mm to about 25 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Martin would not operate differently with the claimed maximum body diameter, as this body diameter would be suitable for providing a sufficient width and therefore sufficient volume to hold and/or receive the first and/or second drug for mixing and subsequent delivery to the patient.
Regarding claim 8, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, but does not mention the specific amount.
However, the range of the predetermined amount of the first drug is a result effective variable in that changing the amount of the first drug is necessary to suit various needs of the patients and would also vary depending on the type of first as well as the type and amount of the second drug to be mixed therewith. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Martin to provide a ratio within the claimed range, as it involves only adjusting the amounts of the first drug which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predetermined amount of the first drug to be from about 3 mL to about 5 mL as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims 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).
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Martin as evidenced by Duddu in view of U.S. Patent Publication No. 2015/0057638 to Davidian et al. (“Davidian”).
Regarding claim 10, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, but does not explicitly mention sodium bicarbonate.
Davidian teaches a first drug is sodium bicarbonate ([0080]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used sodium bicarbonate at the first drug in the syringe cartridge of Martin as taught by Davidian as sodium bicarbonate is a known useful buffer ([0080]) which may be used to provide a buffer anesthetic when combined with lidocaine ([0084]).
Regarding claim 13, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, but does not explicitly mention sodium bicarbonate.
Davidian teaches a first drug is sodium bicarbonate ([0080]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used sodium bicarbonate at the first drug in the syringe cartridge of Martin as taught by Davidian as sodium bicarbonate is a known useful buffer ([0080]) which may be used to provide a buffer anesthetic when combined with lidocaine ([0084]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Martin as evidenced by Duddu in view of U.S. Patent No. 5,599,312 to Higashikawa.
Regarding claim 11, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1, but does not teach an antibiotic.
Higashikawa teaches a first drug is an antibiotic (column 1, lines 31-34, a freeze-dried antibiotic which is meant to be diluted). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an antibiotic as the first drug of Martin as taught by Higashikawa, to yield the predictable result of providing an appropriately mixed medicament to a user. The first drug of Martin is a solid drug intended to be mixed with a diluent, Higashikawa merely shows another example of a solid drug intended to be mixed with a diluent, to suit the particular patient need or treatment plan of the practitioner.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Martin as evidenced by Duddu in view of U.S. Patent Publication No. 2020/0069599 to SMITH et al. (“Smith”).
Regarding claim 12, Martin as evidenced by Duddu teaches the syringe cartridge of claim 1 as shown above, but does not teach an LNP.
Smith teaches a first drug is a lipid nanoparticle (LNP)-formulated nucleoside-modified mRNA ([0563] in a lyophilized or dry form). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an LNP as the first drug of Martin as taught by Smith, to yield the predictable result of providing an appropriately mixed medicament to a user. The first drug of Martin is a solid drug intended to be mixed with a diluent, Smith merely shows another example of a solid drug intended to be mixed with a diluent, to suit the particular patient need or treatment plan of the practitioner.
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Martin as evidenced by Duddu in view of U.S. Patent No. 4,639,250 to Rycroft.
Regarding claim 16, Martin as evidenced by Duddu teaches the syringe of the syringe system of claim 15 as shown above, Martin further teaching a method of administering a second drug (34) to a subject in need thereof, mixing the first and second drug, and injecting the mixture of the first and second drug into the subject (column 2, lines 28-30), but does not teach drawing the second drug.
Rycroft teaches a method comprising drawing a second drug (column 8, lines 42-47). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have drawn the second drug as an substitute to directly injecting the second drug in the method of Martin as taught by Rycroft to yield the predictable result of providing mixing of a dry drug and a diluent prior to injection into a user, both Martin and Rycroft mix a dry drug with a diluent, Rycroft merely showing an obvious alternative means of mixing which has the same result.
Regarding claim 20, Martin as evidenced by Duddu teaches the syringe of the syringe system of claim 15 as shown above, Martin further teaching a method of reconstituting a first drug (column 2, lines 28-30), but does not teach drawing a diluent.
Rycroft teaches a method comprising drawing a diluent (column 8, lines 42-47). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have drawn the diluent as an substitute to directly injecting the diluent in the method of Martin as taught by Rycroft to yield the predictable result of providing mixing of a dry drug and a diluent prior to injection into a user, both Martin and Rycroft mix a dry drug with a diluent, Rycroft merely showing an obvious alternative means of mixing which has the same result.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Martin as evidenced by Duddu in view of Rycroft as applied to claim 16 above, and further in view of U.S. Patent Publication No. 2005/0070874 to Matsuda et al. (“Matsuda”).
Regarding claim 17, Martin, Duddu, and Rycroft teach the method of claim 16 as shown above, but do not explicitly mention the second drug being a caine.
Matsuda teaches a second drug is a caine ([0156], a lidocaine-based diluent used to mix with a solid agent prior to injection). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used lidocaine as the second drug or diluent in the method of Martin and Rycroft as taught by Matsuda to yield the predictable result of providing a diluent. Martin and Rycroft already teach the use of a diluent to mix with a dry drug prior to injection, Matsuda merely teaching one example of such a diluent to suit the particular need of the patient or treatment require by the practitioner.
Regarding claim 18, Martin, Duddu, and Rycroft teach the method of claim 16 as shown above, but do not explicitly mention lidocaine.
Matsuda teaches a second drug is a lidocaine ([0156], a lidocaine-based diluent used to mix with a solid agent prior to injection). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used lidocaine as the second drug or diluent in the method of Martin and Rycroft as taught by Matsuda to yield the predictable result of providing a diluent. Martin and Rycroft already teach the use of a diluent to mix with a dry drug prior to injection, Matsuda merely teaching one example of such a diluent to suit the particular need of the patient or treatment require by the practitioner.
Regarding claim 19, Martin, Duddu, and Rycroft teach the method of claim 16 as shown above, but do not explicitly mention the drug ratio.
However, the range of the ratio of the first drug to the second drug is a result effective variable in that changing the respective amounts of the first and second drug is necessary to suit various needs of the patients and would also vary depending on the type of first and second drug. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Martin to provide a ratio within the claimed range, as it involves only adjusting the relative amounts of each drug which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of the first drug and the second drug to be in the range from about 0.3:20 to about 5:20 as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims 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).
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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