DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of claims 1-2, 4, 6, 11, 16, 22, 28, 31, 37, 40, 41, 50, 52, 59, 74 in the reply filed on 4/9/2025 is acknowledged.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: there are no reference numbers in any figure corresponding to any structure in the claims or specification. 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. 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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed subject matter must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Do to the lack of drawings, quality of photograms and lack of reference numbers it is not possible to determine if any claimed subject matter is shown.
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.
Claim 41 is 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 41 recites a plunger with a terminal end that is flat, this contradicts claim 40 from which it depends. Claim 40 recites a terminal end constructed for piercing a membrane. It is unclear as to how a flat terminal end is constructed for piercing a membrane.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 6, 16, 22, 28, 31, 37, 50, 52, 59, 74 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Genosar (US 20190151194).
Claim 1, Genosar discloses a device for storing, mixing, and administering a composition ([0225], [0019], [0217]),
wherein the device comprises:
a chamber within a main body ([0036]);
a barrier ([0052]);
a plunger ([0063]);
a nozzle ([0167]); and
the components of the composition ([0036]),
wherein the package limits ingress of a contaminating element ([0016]).
Claim 2, Genosar discloses an interior environment for the device ([0175]).
Claim 4, Genosar discloses at least two sheets or layers of materials ([0066]).
Claim 6, Genosar discloses wherein the at least two sheets or layers of material are flexible ([0124]).
Claim 16, Genosar discloses wherein the package comprises an opening mechanism ([0276]).
Claim 22, Genosar discloses wherein the contaminating element comprises dust ([0029]).
Claim 28, Genosar discloses wherein one of the first chamber or the second chamber comprise the components of a composition ([0026]).
Claim 31, the limits of this claim further narrows the multivalent metal and acidic compound (see line C of claim 16) of claim 16 and as such are considered an alternative limitation as indicated in claim 16 (presence of “or” between lines G and H). As claim 16 was rejected over the opening mechanism, the multivalent metal and acid compound are also rejected.
Claim 37, Genosar discloses wherein the barrier comprises a material selected from a polymer or metal ([0194]).
Claim 50, Genosar discloses an adhesive composition ([0074]).
Claim 52, Genosar discloses wherein the packaging comprising the device is agitated to mix the components of a composition ([0059]).
Claim 59, Genosar discloses wherein the composition is dispensed from a chamber within the device into the nozzle ([0018]) by depression of the plunger ((0220]).
Claim 74, Genosar discloses wherein the additional component is a therapeutic agent ([0026]).
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.
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.
Claim(s) 11, 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Genosar as applied to claim 6 above.
Claim 11, Genosar discloses a package similar to the claimed package and further discloses various materials comprising polyolefin/polyethylene ([0194]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Genosar with materials as taught by Genosar in order to use the same materials for package material layers.
Claim 40, Genosar discloses the claimed invention except for shaft and terminal end constructed and arranged for piercing a membrane. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the shape of the plunger, i.e. cone, in order to better pierce a membrane, since it has been held that the configuration was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant. MPEP 2144
Claim 41, Genosar discloses the claimed invention except for the shape of the terminal end of the plunger. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the shape of the plunger, i.e. cone, in order to better pierce a membrane, since it has been held that the configuration was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant. MPEP 2144
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY W CARROLL whose telephone number is (571)272-4988. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Paul Durand can be reached at (571) 272-4459. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JEREMY W. CARROLL
Primary Examiner
Art Unit 3754
/Jeremy Carroll/Primary Examiner, Art Unit 3754