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 .
Specification
The abstract of the disclosure is objected to because legal phraseology, i.e., “comprising”, should be avoided in the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: 1) applicant should insert headings within the specification to improve readability and allow the reader to more readily understand the metes and bounds of the invention relative to the prior art at the time of the filing of the application; 2) on page 1, line 26, applicant should replace the reference to the claims with descriptive language pertaining to the invention disclosure; 3) on page 26, lines 16-19, the commas within the numerals should be replaced by decimal points.
Appropriate correction is required.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
In particular, the foreign references noted on pages 3, 13, and 22 of the instant specification have not been cited on any IDS, nor have copies of the references been submitted for the Examiner’s consideration.
Claim Objections
Claim 42 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 42 has not been further treated on the merits.
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 1, 2, 4, 5, 11, 13, 17, 18, 21, 22, 24, 25, 27-29, 67, 71, and 72 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a liquid” held in the cartridge, and the claim also recites “the liquid is a phospholipid composition”, “the phospholipid composition comprises a hydrated phospholipids solvent mixture”, and “wherein the phospholipids are a combination of a first phospholipid being at least one out of the group of DPPC, DSPC, DSPG, DMPC, DBPC, DPPE, and a second phospholipid being at least one out of the group of DPPE-mPEG5000, DMPE-PEG-2000 and DSPE-PEG2000” which are the narrow, narrower, and narrowest statement of the range/limitation, respectively. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrow, narrower, and narrowest language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Further, with regard to the recitation of independent claim 1, the attempted recitation of the Markush grouping of the combination of phospholipids being the combination of a first phospholipid being at least one of a group of six possible (thus all possible combinations of 1 to 6 of the listed first possible phospholipids) phospholipids, and a second phospholipid being at least one of a group of three possible (thus all possible combinations of 1 to 3 of the listed second possible phospholipids) phospholipids, renders the claim vague and indefinite, since the resultant list of possible phospholipid combinations would confront one having ordinary skill in the art, who when attempting to make and/or use the invention, with an undue multiplicity of possible compositions to consider as to their applicability to the process being contemplated.
Claim 2, which depends from independent claim 1, speaks of a “fluid” being held within the cartridge and being propelled from a storage unit of the cartridge by a pressurized gas. However, claim 1, as currently recited, provides for the interaction of a “gas” and a “liquid”, which are narrower than the broad recitation of “fluid” within claim 2, thereby rendering claim 2 vague and indefinite, since it recites an operation that is broader in scope than that of independent claim 1. Claim 2 is also vague and indefinite in that it refers to “said phospholipid composition”, which may not exist within the device of independent claim 1, from which claim 2 depends, since claim 1 may only be required to be capable of working on “a liquid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above). Alternatively, if claim 1 is interpreted as capable of working on “a hydrated phospholipids solvent mixture”, the recitation of “said phospholipid composition” within claim 2 would be seen as improperly broadening the scope of the narrower interpretation of claim 1, thus rendering claim 2 as vague and indefinite.
Claim 4 is vague and indefinite in that it refers to “the hydrated phospholipids solvent mixture”, which may or may not exist within the device of independent claim 1, from which claim 4 depends (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above). Claim 4 is also vague and indefinite, since it depends from an apparatus claim (independent claim 1) drawn to a cartridge for acting upon a gas and a liquid, while claim 4 is drawn to a process for preparing a hydrated phospholipids solvent mixture, apparently at a location removed from the cartridge of claim 1. Therefore, claim 4 is not seen as further limiting the structure of the cartridge of claim 1 in any way, and in fact does not appear to even relate to the cartridge of claim 1.
Claim 5 is vague and indefinite in that it refers to “the hydrated phospholipids solvent mixture”, which may or may not exist within the device of independent claim 1, from which claim 5 indirectly depends (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above). Claim 5 is also vague and indefinite, since it depends from an apparatus claim (independent claim 1) drawn to a cartridge for acting upon a gas and a liquid, while claim 5 is drawn to a process for preparing a hydrated phospholipids solvent mixture, apparently at a location removed from the cartridge of claim 1. Therefore, claim 5 is not seen as further limiting the structure of the cartridge of claim 1 in any way, and in fact does not appear to even relate to the cartridge of claim 1. Lastly, in claim 5, line 4, the term “preferably” renders the claim vague and indefinite since it is unclear as to whether the terms that follow “preferably” are required, or directed to optional aspects of the claimed invention.
In claim 11, line 2, “each fluid storage unit” lacks antecedent basis, since claim 4, from which claim 11 depends, does not introduce or recite “a fluid storage unit”. Also, in claim 11, line 5 speaks of a “fluid” being in the fluid storage unit, which renders the claim vague and indefinite, since claim 1, from which claim 11 indirectly depends, provides for the interaction of a “gas” and a “liquid”, which are narrower than the broad recitation of “fluid” within claim 11, thereby rendering claim 11 vague and indefinite, since it recites an operation that is broader in scope than that of independent claim 1.
In claim 13, “the sealed off containers” lack antecedent basis, since claim 11, from which claim 13 depends, only recites a single “sealed off container”.
In claim 18, lines 2-3, “the cartridge body” lacks antecedent basis. Applicant should note that claim 2, which introduces “a cartridge body”, does not serve as a basis for claim 18, since claim 18 depends directly from claim 17, and indirectly from claims 1, 4, and 11. Claim 18 also lacks a period at the end of the claim.
In claim 21, line 1, “according to claim 2 any of” does not make sense.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 22 recites the broad recitation “at least one fluid storage unit”, and the claim also recites “a single fluid storage unit” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Also, in claim 22, “the at least one fluid storage unit” lacks antecedent basis, since the recitation is not the same as “one or more fluid storage units”.
In claim 24, it is noted that applicant recites “one liquid” being received from the fluid storage system, while claim 2, from which it depends speaks of a “fluid” within the fluid storage system. While claim 24 can be said to properly narrow the scope of the material worked on from “fluid” to “liquid”, claim 24 is indirectly dependent upon claim 1, which is directed to mixing a liquid with a gas. Applicant should use consistent language throughout the claims, avoiding the apparent interchangeable use of non-commensurate terms, such as fluid and liquid, or fluid and gas.
Claim 27 is vague and indefinite in that it refers to “said phospholipid composition”, which may not exist within the device of independent claim 1, from which claim 27 depends, since claim 1 may only be required to be capable of working on “a liquid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above). Alternatively, if claim 1 is interpreted as capable of working on “a hydrated phospholipids solvent mixture”, the recitation of “said phospholipid composition” within claim 27 would be seen as improperly broadening the scope of the narrower interpretation of claim 1, thus rendering claim 27 as vague and indefinite.
Claim 28 is vague and indefinite in that it refers to “the phospholipid composition”, which may not exist within the device of independent claim 1, from which claim 28 depends, since claim 1 may only be required to be capable of working on “a liquid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above). Alternatively, if claim 1 is interpreted as capable of working on “a hydrated phospholipids solvent mixture”, the recitation of “the phospholipid composition” within claim 28 would be seen as improperly broadening the scope of the narrower interpretation of claim 1, thus rendering claim 28 as vague and indefinite.
Claim 29 is vague and indefinite in that it refers to “said phospholipid composition”, which may not exist within the device of independent claim 1, from which claim 29 depends, since claim 1 may only be required to be capable of working on “a liquid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above). Alternatively, if claim 1 is interpreted as capable of working on “a hydrated phospholipids solvent mixture”, the recitation of “said phospholipid composition” within claim 29 would be seen as improperly broadening the scope of the narrower interpretation of claim 1, thus rendering claim 29 as vague and indefinite.
In claim 67, it is noted that applicant recites “liquid(s)” being received from the fluid storage system, while claim 2, from which it depends speaks of a “fluid” within the fluid storage system. While claim 67 can be said to properly narrow the scope of the material worked on from “fluid” to “liquid”, claim 67 is indirectly dependent upon claim 1, which is directed to mixing a liquid with a gas. Applicant should use consistent language throughout the claims, avoiding the apparent interchangeable use of non-commensurate terms, such as fluid and liquid, or fluid and gas.
Claim 71 is vague and indefinite in that it refers to “the hydrated phospholipids solvent mixture”, which may or may not exist within the device of independent claim 1, from which claim 71 directly depends (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 4, 5, 27-29, and 71 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. If claim 1 is interpreted as capable of working on “a hydrated phospholipids solvent mixture”, the recitation of “said phospholipid composition” within claims 2, and 27-29 would be seen as improperly broadening the scope of the narrower interpretation of claim 1. Further, if claim 1 is interpreted as capable of working on “a hydrated phospholipids solvent mixture wherein the phospholipids are a combination of a first phospholipid being at least one out of the group of DPPC, DSPC, DSPG, DMPC, DBPC, DPPE, and a second phospholipid being at least one out of the group of DPPE-mPEG5000, DMPE-PEG-2000 and DSPE-PEG2000”, the recitation of “the hydrated phospholipids solvent mixture” within claims 4, 5, and 71 would be seen as improperly broadening the scope of the narrower interpretation of claim 1. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 102
(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, 2, 4, 5, 21, 24, 25, 27-29, 67, 71, and 72 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by van Hoeve et al ‘400.
van Hoeve et al ‘400 (Abstract; Figs. 1, 2A, 4; paragraphs [0002]-[0010], [0015]-[0033]) disclose a cartridge (2) for mixing a liquid (20) in the cartridge (a liquid in the cartridge is inherently held in the cartridge) with a pressurized gas (10) supplied to the cartridge, wherein the liquid is a phospholipid composition (see [0033], which clearly discloses a mixture of DPPC and DPPE-PEG5000, as set forth by claim 1). It is noted that the cartridge (2) is releasably connected to or received by the device (10, 20) that supplies pressurized gases to the cartridge for moving the liquids within the cartridge and mixing them therein to provide the desired microbubble generation within the liquid within the cartridge (claim 67). Applicant should note that the specific material worked on by the claimed apparatus, including the chosen components of any phospholipid mixture, the concentration thereof, and the ratio of the mixture components are not considered to limit the claimed apparatus in any patentable sense, and therefore the recited materials being worked on by the apparatus cannot be considered to lend patentable weight thereto the apparatus (claims 1 and 71).
With respect to the specifics of instant claim 2, the cartridge includes a body having one or more gas inlets (112, 212), a fluid storage system formed in the cartridge body and comprising one or more fluid storage units (110, 120), each fluid storage unit being configured to hold a fluid (residual air in channel (110) is a fluid, as is the phospholipid mixture introduced to channels (120, 120’) via inlets (122, 222), and for outputting the fluid in response to a pressurized gas supplied to the fluid storage unit via gas inlets (112, 212) by using the supplied gas as a propellant (claims 21 and 67); a mixing unit (130) arranged in or mounted to the cartridge body and being in fluid communication with the fluid storage units using a fluid channel or fluid channels formed in the cartridge body, said mixing unit being configured for mixing respective fluids outputted from respective fluid storage units or for mixing a fluid outputted from a fluid storage unit with the pressurized first gas received through a gas inlet among the one or more gas inlets, wherein at least one fluid held in the fluid storage system and configured to be mixed is said phospholipid composition (paragraph [0033]) (claim 2). Wherein claims 4 and 5 are drawn to a process for preparing a hydrated phospholipids solvent mixture, apparently separate from the claimed cartridge apparatus, such is not seen as relevant to the claimed invention of independent claim 1 (drawn to a cartridge for mixing a gas or further liquid with a phospholipid composition), and therefore, since the reference clearly teaches contacting a phospholipid mixture with a gas to form microbubbles therein, any manner of preparing the phospholipid mixture would be well within the purview of the prior art.
The reference also clearly teaches a microfluidics device (1) that forms the mixing unit that forms microbubbles within the liquid that are filled with the pressurized gas, the microbubbles having an accurately controlled diameter of less than 10 micrometers, preferably in the range of 2-5 micrometers (see paragraph [0009]) (claims 24, 25, 72).
Lastly, with regard to the microfluidics device of instant claims 27-29, the microfluidics device (1) of the reference clearly discloses a first inlet (112) for receiving the pressurized gas, a second inlet (122) for receiving the phospholipid composition, and a bubble formation channel (130) for generating microbubbles based on the flow through the first and second inlets (claim 27); the cartridge body including a first opening (212) aligned with the first inlet (112), a second opening (222) aligned with the second inlet (122), and a third opening (260) aligned with the outlet (160) of the microfluidics device (1), the device (1) connected to the body (2) (see [0015]) (claim 28); the microfluidics device including a flow focusing junction (140), with first and second channels (120, 120’) connecting the second inlet (122) and the flow focusing junction (140), a third channel (110) connecting the first inlet (112) to the flow focusing junction (140), the bubble formation channel (130) connected to the flow focusing junction (140), the phospholipid composition being carried by the first and second channels into the flow focusing junction at perpendicular angles to the third channel which carries the pressurized gas to the flow focusing junction and into the bubble formation channel (see Fig. 2A) (claims 27-29).
Allowable Subject Matter
Claims 11, 13, 17, 18, and 22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose or suggest the rupturable, sterile, sealed off container within a storage chamber of a fluid storage unit configured to receive the container, with a liquid reservoir in fluid communication with the storage chamber to receive the liquid from the container when the sealed off container is broken, ruptured, cut or pierced, the liquid being mixed within the cartridge, as defined by instant claims 1, 4, and 11. Claims 13, 17, and 18 would be allowable based upon their dependency on an allowable claim 11.
The prior art of record also fails to disclose or suggest the specific cartridge as set forth by instant claim 22, as it depends from claims 1 and 2, wherein the cartridge includes a single fluid storage unit with two gas inlets for delivering two different pressurized gases to the cartridge.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES S BUSHEY whose telephone number is (571)272-1153. The examiner can normally be reached M-Th 6:30-5:00.
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, Jennifer Dieterle can be reached at 571-270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.S.B/1-19-26
/CHARLES S BUSHEY/ Primary Examiner, Art Unit 1776