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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-13 and 21-27 in the reply filed on 01/12/2026 is acknowledged.
Claim Rejections - 35 USC § 112
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.
Claim 21 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.
Regarding claim 21, the recitation of “wherein the filter is positioned to surround the at least one opening to prevent the liquid, the medication powder, or the mixture thereof from passing through said at least one opening” does not further limit the subject matter of “wherein the filter is positioned to surround the at least one opening to prevent the liquid, the medication powder, or the mixture thereof from passing through said at least one opening” of claim 13.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3, 6-13 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Klearman (US5472421A) in view of Paradis (US6063062A) and Nakagami (US20210113811A1).
Regarding claim 1, Klearman discloses a device for grinding or crushing one or more pieces of solid medication (abstract), the device comprising:
a male grinder (fig.13: (202)) component having a proximal end (fig.13: the end at the element (230)), a distal end (fig.13: the end at the element (232)), and a first plurality of serrated edges (figs.13 and 17: (242)) on an outer surface (figs.13 and 17: (232)) of the male grinder;
a female grinder (fig.13: (200)) component defining a chamber (fig.13: the chamber of the element (202)) for receiving the one or more pieces of solid medication,
wherein the distal end (fig.13: the end at the element (232)) of the male grinder component is configured to be at least partially received into the chamber of the female grinder component to form an enclosed chamber (fig.13: that chamber between the elements (200) and (202)),
wherein an outer surface of the chamber of the female grinder component comprises a second plurality of serrated edges (figs.13 and 15: (216)), and
wherein, as the male grinder component is rotated relative to the female grinder component, the first plurality of serrated edges is configured to move relative to the second plurality of serrated edges thereby grinding the one or more pieces of solid medication into a powder (col.12 lines 25-46).
Klearman does not disclose a spring, wherein a distal end of the female grinder component is configured to receive the spring; a valve comprising a stopper member, wherein the valve is coupled with the spring; an adapter coupled with the valve and the distal end of the female grinder component, wherein the adapter is configured to selectively seal the enclosed chamber; and a filter positioned between the distal end of female grinder component and the adapter, wherein the filter is adapted to prevent liquid, medication powder, or a mixture thereof from passing through the device and wherein the filter is further adapted to allow air to pass in and out from the enclosed chamber.
Paradis teaches a valve (fig.1A: (13)) comprising a stopper member (fig.1A: (13-b)), wherein the valve is coupled with a spring (fig.1A-1B: (14)); and an adapter (fig.1A: (11)) coupled with the valve, wherein the adapter is configured to selectively seal (abstract and col.6-col.7);
Both of the prior arts of Klearman and Paradis are related to are related to a medical device;
Therefore, 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 apparatus of Klearman to have the configuration of a valve and a spring as taught by Paradis, since it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. [KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)]. Thereby having a spring, wherein a distal end of the female grinder component is configured to receive the spring; a valve comprising a stopper member, wherein the valve is coupled with the spring; an adapter coupled with the valve and the distal end of the female grinder component, wherein the adapter is configured to selectively seal the enclosed chamber.
Klearman in view of Paradis does not disclose a filter positioned between a distal end a component and the adapter, wherein the filter is adapted to prevent liquid, medication powder, or a mixture thereof from passing through the device and wherein the filter is further adapted to allow air to pass in and out from the enclosed chamber.
Nakagami teaches a filter positioned between a distal end of a component (figs.13-14: (39)) and an adapter (figs.13-14: (13)), wherein the filter is adapted to prevent liquid, medication powder, or a mixture thereof from passing through a device and wherein the filter is further adapted to allow air to pass in and out from an enclosed chamber (paragraphs 0120-0122).
Both of the prior arts of Klearman and Nakagami are related to are related to a medical device;
Therefore, 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 apparatus of Klearman in view of Paradis to have the configuration of a filter as taught by Paradis, since it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. [KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)]. Thereby having a filter positioned between the distal end of female grinder component and the adapter, wherein the filter is adapted to prevent liquid, medication powder, or a mixture thereof from passing through the device and wherein the filter is further adapted to allow air to pass in and out from the enclosed chamber.
Regarding claim 2, Paradis teaches a syringe, wherein the adapter is a syringe adapter configured to receive the syringe (col.6 last 4 lines), and wherein the syringe is configured to inject liquid into the enclosed chamber.
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 2.
Regarding claim 3, Klearman discloses wherein each of the first plurality of serrated edges has a first end and a second end and wherein spacings between the first ends of each of the first plurality of serrated edges is less than spacings between the second ends of each of the first plurality of serrated edges (fig.19).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 3.
Regarding claim 6, Klearman discloses a retainer ring (fig.21: (236)), wherein the proximal end of the female grinder component comprises a slot (fig.17: (238)) for receiving the retainer ring and wherein the retainer ring is a member adapted to couple to the male grinder component and prevent the male grinder component from disconnecting from the female grinder component during operation (fig.21).
Klearman in view of Paradis and Nakagami does not disclose wherein the proximal end of the female grinder component comprises a plurality of slots for receiving the retainer ring and wherein the retainer ring comprises a plurality of members;
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to Klearman in view of Paradis and Nakagami to add slots and retainer ring as many as desired in order to optimizing the sealing between the male and female grinding components. (MPEP 2144.04 VI, B)
Regarding claim 7, Paradis teaches wherein the stopper member (fig.1A: (13-b)) is configured to be pushed inside the spring when the syringe is connected to the syringe adapter (figs.1B-1C).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 7.
Regarding claim 8, Paradis teaches wherein, upon the stopper member being pushed relative to the spring (fig.1C), at least one opening (fig.1A: lower (B’)) is adapted to be positioned in the chamber
Klearman discloses the enclosed chamber and the liquid to be mixed with the powder to form a liquid and powder mixture.
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 8.
Regarding claim 9, Klearman discloses at least one sealing member (fig.21: (236)) coupled with the female grinder component for preventing the liquid and powder mixture from leaking out the enclosed chamber.
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 9.
Regarding claim 10, Klearman in view of Paradis and Nakagami does not disclose wherein the spring is characterized by a spring rate and wherein the spring rate has a value ranging from 0.09 lbs/mm to 0.27 lbs/mm;
However, Paradis teaches the spring (fig.1D: (14));
Further, choosing the spring rate is very known in art and a matter of routine engineering design choice that depends on requirement of the process as desired;
Therefore; it would have been obvious to one of ordinary skill in the art at the time of the invention to have wherein the spring is characterized by a spring rate and wherein the spring rate has a value ranging from 0.09 lbs/mm to 0.27 lbs/mm in order to meet a specific requirement of the process of as desired such as liquid-tight sealing.
Regarding claim 11, Klearman in view of Paradis and Nakagami does not disclose wherein at least a portion of the female grinder component is transparent to enable a user to view the grinding of the solid medication;
However, the examiner takes official notice that it was well known in the art at the time of the invention to connect separate parts together using releasably engageable couplings mounted to the separate parts;
Therefore; it would have been obvious to one of ordinary skill in the art at the time of the invention to have wherein at least a portion of the female grinder component is transparent to enable a user to view the grinding of the solid medication.
Regarding claim 12, Nakagami teaches wherein the filter is a hydrophobic filter (paragraph 0012).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 12.
Regarding claim 13, Paradis teaches wherein the valve is a hollow member comprising at least one opening (fig.1A: lower (B’)); and
Nakagami teaches wherein the filter (fig.15: (55)) is positioned to surround at least one opening to prevent the liquid, the medication powder, or the mixture thereof from passing through said at least one opening (paragraphs 0120-0121).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 13.
Regarding claim 21, Nakagami teaches wherein the filter (fig.15: (55)) is positioned to surround at least one opening to prevent the liquid, the medication powder, or the mixture thereof from passing through said at least one opening (paragraphs 0120-0121).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 21.
Regarding claim 22, Klearman in view of Paradis and Nakagami does not disclose wherein the at least one opening has a diameter ranging from 1.25 mm to 5 mm and is configured to allow powder particles in a same size range to pass therethrough;
However, choosing the dimensions of the parts is very known in art and a matter of routine engineering design choice that depends on the general design of the grinder and specific requirements of the process as desired;
Therefore; it would have been obvious to one of ordinary skill in the art at the time of the invention to select the size of opening as desired, including wherein the at least one opening has a diameter ranging from 1.25 mm to 5 mm and is configured to allow powder particles in a same size range to pass therethrough; in order to meet a specific requirement of the process of the grinding as desired.
Regarding claim 23, Klearman discloses wherein the male grinder component and the female grinder component are configured to generate a sound when rotated with respect to one another and wherein the sound changes in pitch as the one or more pieces of solid medication is ground into the powder (col.12 lines 1-24).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 23.
Regarding claim 24, Klearman discloses wherein the male grinder component has a convex shape and the female grinder component has a funnel shape (fig.13).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 24.
Regarding claim 25, Klearman discloses wherein the first plurality of serrated edges (fig.13: (242)) and the second plurality of serrated edges (fig.13: (216)) each comprise one or more teeth and wherein the number of teeth in each of the first plurality of serrated edges and in the second plurality of serrated edges ranges from 1 to 100.
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 25.
Regarding claim 26, Klearman discloses wherein the first plurality of serrated edges (fig.13: (242)) and the second plurality of serrated edges (fig.13: (216)) are configured to match, such that the first plurality of serrated edges and the second plurality of serrated edges intermesh with each other when the male grinder component is inserted into the female grinder component and the one or more pieces of solid medication are crushed when the male grinder component is rotated relative to the female grinder component (col.12 lines 25-46).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 26.
Regarding claim 27, Klearman discloses wherein the first plurality of serrated edges (fig.13: (242)) and the second plurality of serrated edges (fig.13: (216)) are configured to allow for clockwise or counter-clockwise rotation of the male grinder component relative to the female grinder component to grind the one or more pieces of solid medication into the powder (col.12 lines 25-46).
Therefore, the modification of Klearman in view of Paradis and Nakagami teaches the limitations of claim 27.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Klearman (US5472421A) in view of Paradis (US6063062A) and Nakagami (US20210113811A1) as applied to claim 1 above, and further in view of Trombetti (US4366930A).
Regarding claim 4, Klearman in view of Paradis and Nakagami does not disclose wherein the proximal end of the male grinder component comprises grooves for enabling a hand-grip of the male grinder component and a rotation thereof with respect to the female grinder component.
Trombetti teaches a proximal end (fig.2: (60)) of a male grinder component (fig.2: (30), (44) and (60)) comprises grooves (fig.5: see the grooves of the element (64)) for enabling a hand-grip of the male grinder component and a rotation thereof with respect to a female grinder component (fig.2: (12)).
Both of the prior arts of Klearman and Trombetti are related to are related to a medical device;
Therefore, 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 apparatus of Klearman in view of Paradis and Nakagami to have wherein the proximal end of the male grinder component comprises grooves for enabling a hand-grip of the male grinder component and a rotation thereof with respect to the female grinder component as taught by Trombetti, since it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. [KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)].
Regarding claim 5, Klearman in view of Paradis and Nakagami does not disclose wherein a length of the male grinder component ranging from 0.05 inches to 5 inches remains protruding above the female grinder component during crushing of the one or more pieces of solid medication.
However, choosing the dimensions of the parts is very known in art and a matter of routine engineering design choice that depends on the general design of the grinder and specific requirements of the process as desired;
Therefore; it would have been obvious to one of ordinary skill in the art at the time of the invention to select the size of opening as desired, including wherein a length of the male grinder component ranging from 0.05 inches to 5 inches remains protruding above the female grinder component during crushing of the one or more pieces of solid medication; in order to meet a specific requirement of the process of the grinding as desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ALAWADI whose telephone number is (571)272-2224. The examiner can normally be reached 08:00 am- 05:00 pm.
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, CHRISTOPHER TEMPLETON can be reached at (571)270-1477. 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.
/MOHAMMED S. ALAWADI/Primary Examiner, Art Unit 3725