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 .
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, 5, 13, 17, 18, 21, 22, 24, 25, 27-29, 42, 67, and 71-73 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 fluid” held in the cartridge, and the claim also recites “the fluid is a phospholipid composition”, “the phospholipid composition comprises a hydrated phospholipids solvent mixture”, and “the hydrated phospholipids solvent mixture comprises a first phospholipid comprising DPPC, DSPC, DSPG, DMPC, DBPC, or DPPE, and a second phospholipid comprising DPPE-mPEG5000, DMPE-PEG-2000, or 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 recitation of the hydrated phospholipids solvent mixture comprises a first phospholipid comprising 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 comprising 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 is vague and indefinite in that it refers to “said hydrated phospholipids solvent mixture”, 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 fluid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above).
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 directly depends (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above).
In claim 17, “said at least one fluid storage unit” does not find antecedence in amended independent claim 1 and should be replaced by --said one or more fluid storage units--, to be consistent with the language of amended claim 1.
In claim 18, line 2, “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 claim 1, neither of which recite “a cartridge body”.
In claim 22, lines 2-3, “the one or more one fluid storage units” does not make sense.
Claim 27 is vague and indefinite in that it refers to “said hydrated phospholipids solvent mixture”, 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 fluid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above).
Claim 28 is vague and indefinite in that it refers to “the hydrated phospholipids solvent mixture”, 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 fluid” that is held in the cartridge (see the broad vs. narrow range or limitation discussion with respect to independent claim 1 above).
Claim 29 is vague and indefinite in that it refers to “said hydrated phospholipids solvent mixture”, 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).
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).
With regard to newly added independent claim 73, 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 73 recites the broad recitation “a fluid” held in the cartridge, and the claim also recites “the fluid is a phospholipid composition”, “the phospholipid composition comprises a hydrated phospholipids solvent mixture”, and “the hydrated phospholipids solvent mixture comprises a first phospholipid comprising DPPC, DSPC, DSPG, DMPC, DBPC, or DPPE, and a second phospholipid comprising DPPE-mPEG5000, DMPE-PEG-2000, or 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 73, the recitation of the hydrated phospholipids solvent mixture comprises a first phospholipid comprising 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 comprising 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.
Response to Amendment
The amendment, as filed on April 27, 2026, with regard to dependent claim 21, is improper, since the claim has been amended without markings to remove the phrase “any of” after “claim 2”, on line 1 of the claim. Further, applicant has also provided claim 21 with an improper status identifier due to the amendment, albeit improper, to amend the claim to alter the language thereof, while using the improper status identifier “previously presented”, rather than “currently amended”, which should have been used.
Allowable Subject Matter
Claims 1, 2, 5, 13, 17, 18, 21, 22, 24, 25, 27-29, 42, 67, and 71-73 would be allowable if rewritten or amended 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.
Claims 1 and 73, the only independent claims in the case have been written to include language of previously indicated allowable claims 11 and 22, and therefore would be allowable for the reasons of record.
Response to Arguments
Applicant's arguments filed on April 27, 2026, with regard to the rejections of the claims under 35 USC 112 (b) have been fully considered but they are not persuasive. With regard to the statement that the hydrated phospholipids solvent mixture is the material worked on, the language of the instant claims belie such, since the independent claims 1 and 73, each recite broad (fluid), narrow (phospholipid composition), narrower (hydrated phospholipids solvent mixture), and a narrowest recitation (a combination of selected first and second phospholipids within the hydrated phospholipids solvent mixture). If applicant wishes to have a patent for the claimed cartridge containing a phospholipids solvent mixture, then the claims must clearly and distinctly recite a class of such material that is well understood and not open to misinterpretation of the scope of the patent protection desired.
Conclusion
Applicant's amendment necessitated the new grounds 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 CHARLES S BUSHEY whose telephone number is (571)272-1153. The examiner can normally be reached M-Th 6:30-5:00.
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/C.S.B/7-25-26
/CHARLES S BUSHEY/ Primary Examiner, Art Unit 1776
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