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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 9/22/2025 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a deployment mechanism configured to move the syringe relative to the housing from a retracted position to a deployed position in which the needle projects beyond the baseplate” in claims 1, 16, 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 17-20 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 17-20 depend from claim 15 which has been cancelled. Therefore, the scope of the claim cannot be determined. However, for the purposes of this examination, it is assumed that these claims are intended to depend from claim 16. Appropriate correction is required.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fourt et al (US 2015/0246181) in view of Haber et al (US 5,609,577) in view of Homan et al (6,936,028) in view of Thermal Stimulator (JP 2013540545 A) [English translation of Inventor/Applicant name not available; for ease of discussion, references are made to machine translation provided herewith].
Regarding claim 1, Fourt discloses an injection device comprising: a housing 24 (fig. 5a); a baseplate 105 coupled to the housing (fig. 6a, page 3, para. 0050) the baseplate including a flange portion 107 and an axial portion 11 that extends from the flange portion in a longitudinal direction of the housing (fig. 6a); a syringe 130 at least partially disposed within the housing (fig. 2; page 3, para. 0051), the syringe including a needle 134 (fig. 2; page 3, para. 0051); and a deployment mechanism configured to move the syringe relative to the housing from a retracted position (fig. 2) to a deployed position in which the needle projects beyond the baseplate (fig. 18; pages 3-4, para. 0055: deployment mechanism includes at least plunger 136, button 25, spring 155) ,wherein at least a portion of the syringe is visible when the syringe is in the retracted position (page 3, para. 0049: housing is transparent which allows the syringe to be viewed).
Claim 1 further calls for the baseplate to be an opaque polymer. Fourt discloses that the baseplate is a polymer (page 3, paras 0049, 0050: plastic), but discloses that the material is transparent. Haber teaches a syringe having a needle guard which is analogous to the baseplate of Fourt, wherein the needle guard is made of an opaque material to hide the needle from the patient (col. 2, lines 14-17) thereby reducing patient discomfort and fear. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plastic material of the base plate of Fourt to be opaque as taught by Haber to hide the needle from the patient thereby reducing discomfort and fear during use of the device.
Claim 1 further calls for the polymer material of the base to be more thermally conductive than a material of the housing. Homan teaches a syringe having a baseplate that carries a cooling element having a highly heat-conductive coating on the skin contacting surface which favors heat conduction and consequently a quicker cooling of the skin to reduce pain associated with the injection (col. 2, lines 34-39; fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the baseplate of Fourt to include a cooling material and a thermally conductive material, the thermally conductive material being more thermally conductive than the body to direct the cooling toward the skin as taught by Homan to provide a numbing effect to the tissue and reduce pain associated with the injection.
Homan fails to teach that the thermally conductive material is a polymer. Thermal Stimulator teaches a device for cooling the skin wherein the skin contacting surface is formed from a plastic polymer that has a high thermal conductivity to provide a uniform temperature distribution to the skin (page 7, 3rd paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the baseplate of Fourt in view of Homan to include the material that is more thermally conductive than a material of the housing as discussed above to be a thermally conductive material as taught by Thermal Stimulator because such a material is suitable for providing cooling to the skin in a uniform manner to prevent under or over cooling.
Regarding claim 2, Fourt discloses that the syringe is filled with a medication (page3, para. 0051).
Claim 3 calls for at least a portion of the medication is visible when the syringe is in the retracted position. Fourt discloses that the housing is formed from a transparent material as discussed above, but fails to specifically disclose that at least a portion of the medication is visible when the syringe is in the retracted position. Haber teaches a syringe having a housing that includes windows to enable the user to visually inspect the volume of fluid in the syringe prior to use, i.e. in the retracted position (col. 5, lines 25-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Fourt to include windows enable the medication to be visible when the syringe is in the retracted position as taught by Haber to that the user can ensure that the syringe carries enough medicament for the desire dose.
Regarding claim 4, Fourt discloses that the axial portion of the baseplate includes an opening passing through the axial portion in a direction perpendicular to the longitudinal direction (fig. 6a: notches at the proximal portion of the axial portion 111 are interpreted to be openings), and the at least a portion of the syringe is visible through the opening (the housing is formed from a transparent material and therefore a portion of the syringe can be viewed through the openings).
Regarding claim 5, Fourt discloses that the opening includes a gap or a window (fig. 6a).
Regarding claim 6, Fourt discloses that a proximal end of the axial portion of the baseplate is distal to a proximal end of the syringe when the syringe is in the retracted position (see fig. 2 annotated below).
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Claim 7 differs from Fourt in calling for a skin-contacting surface of the flange portion of the baseplate includes a plurality of protrusions. Haber further teaches a syringe having a skin contacting surface having a plurality of protrusions 36 to confuse the senses of the patient and thereby minimize discomfort of needle insertion (col. 5, lines 11-15; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the skin contacting portion of Fourt to include protrusions as taught by Haber to confuse the patient’s senses and thereby reduce pain associated with insertion of the needle.
Regarding claim 8, Thermal Stimulator further discloses that the material of the base plate is electrically resistive (non-conductive: page 8, 4th paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the thermally conductive polymer taught by Thermal Stimulator discussed above would be thermally resistive as Thermal Stimulator teaches that this is a property of the material.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fourt in view of Homan.
Regarding claim 16, Fourt discloses an injection device comprising: a housing 24 (fig. 5a); a baseplate 105 coupled to the housing (fig. 6a; page 3, para. 0050), the baseplate including a flange portion 107 and an axial portion 111 that extends from the flange portion in a longitudinal direction of the housing (fig. 6a), wherein the axial portion includes an opening passing through the axial portion in a direction perpendicular to the longitudinal direction (fig. 6a: notches on the proximal end of the axial portion are interpreted to be openings); and a deployment mechanism configured to move a syringe relative to the housing from a retracted position (fig. 2) to a deployed position in which a needle of the syringe projects beyond the baseplate (fig. 18; pages 3-4, para. 0055: deployment mechanism includes at least plunger 136, button 25, spring 155).
Claim 16 differs from Fourt in calling for the base plate to be thermally conductive. Homan teaches a syringe having a baseplate that carries a cooling element having a highly heat-conductive coating on the skin contacting surface which favors heat conduction and consequently a quicker cooling of the skin to reduce pain associated with the injection (col. 2, lines 34-39; fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the baseplate of Fourt to include a cooling material and a thermally conductive material to direct the cooling toward the skin as taught by Homan to provide a numbing effect to the tissue and reduce pain associated with the injection.
Regarding claim 17, Fourt discloses that the housing and the base plate of formed from a transparent material (page 3, para. 0049, 0050) and therefore at least a portion of the syringe is visible through the opening.
Regarding claim 18, Fourt discloses that the opening includes a gap or a window (fig. 6a).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fourt in view of Homan as applied to claim 15 above, and further in view of Haber.
Regarding claim 19, Fourt discloses that the syringe is filled with a medication (page3, para. 0051). Fourt discloses that the housing is formed from a transparent material as discussed above, but fails to specifically disclose that at least a portion of the medication is visible when the syringe is in the retracted position. Haber teaches a syringe having a housing that includes windows to enable the user to visually inspect the volume of fluid in the syringe prior to use, i.e. in the retracted position (col. 5, lines 25-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Fourt to include windows enable the medication to be visible when the syringe is in the retracted position as taught by Haber to that the user can ensure that the syringe carries enough medicament for the desire dose.
Allowable Subject Matter
Claims 21-23 are allowed.
Claims 9, 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 21, the prior art fails to teach or fairly suggest an injection device wherein an axial portion of the baseplate is in contact with the syringe when the syringe is in the retracted position and wherein in response to skin contact with the flange portion, heat is configured to be transmitted through the flange portion and the axial potion of the baseplate to the syringe, in combination with the features of the invention, substantially as claimed. See the references cited above for the closest prior art of record.
Regarding claim 9, the prior art fails to disclose the baseplate comprises a material configured to transfer at least 3 Watts for the initial second of injection or an average of 1.6 Watts over a period of time of 10 seconds from a heat source with a temperature of 37 degrees C, in combination with the features of the invention, substantially as claimed.
Regarding claim 20, the prior art fails to disclose the baseplate comprises a material with a thermal conductivity in each of a mold flow and a mold crossflow directions of at least 24 W/(m K), in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783