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 Objections Claim s 1, 3, 6, and 7 are objected to because of the following informalities: Claim 1, line 3 should be amended to read -- a canister and;-- to correct a grammatical/typographical error. Claim 1, line 4 should be amended to read --… a breath breathe ;-- to correct a grammatical/typographical error. Claim 1, line 5 should be amended to read –wherein the pneumatic force holding unit comprising comprises a compression spring…;-- to correct grammatical/typographical error. Claim 1, line 9 should be amended to read --… the breath breathe ;-- to correct a grammatical/typographical error. Claim 3, lines 1-3 should be amended to read --…wherein a the central rigid disk and a the peripheral flexible polymer ring of the diaphragm is formed by a two shot injection molding process.-- to correct grammatical/typographical errors. Claim 6, line 1 should be amended to read --…wherein a the central rigid disk…-- to correct a grammatical/typographical error Claim 7, line 3 should be amended to read -- a canister and;-- to correct a grammatical/typographical error. Claim 7, line 4 should be amended to read --… a breath breathe ;-- to correct a grammatical/typographical error. Claim 7, line 5 should be amended to read –wherein the pneumatic force holding unit comprising comprises a compression spring…;-- to correct grammatical/typographical error. Appropriate correction is required. 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. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. In claim 1, “interlocking means” is interpreted according to page 3 lines 19-21 of the Specification as “ one or more grooves or cavities ”. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim s 2, 5, 7 , and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 2 (lines 1-2) and claim 7 (line 8) each recite “the flap consists of a soft elastomer component”. The phrase “consists of” is recognized as closed, meaning it excludes any element, step or ingredient not specified in the claim (see MPEP 2111.03 II). Thus, the claim reads as though the flap only include s one component (the soft elastomer component) and no other components can be included as part of the flap to read on the claimed invention . However, the Specification recites in each instance that “the flap consists of a rigid component and the soft elastomer component” (see for example page 5, line 4 of the instant Specification). Therefore, there is no support in the written description for a flap having just the soft elastomer component without the rigid component. Examiner suggests amending the claims to read: --the flap consists of comprises a soft elastomer component to overcome the rejection. Claims 5 and 8 are rejected based on their dependency to rejected claims. 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 s 1-8 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 pre-AIA the applicant regards as the invention. Claim 1 recites the limitation " the dose " in line 4 and “the interlocking means” in line 10 . There is insufficient antecedent basis for th ese limitation s in the claim. Claim 1 recites “a compression spring (preload)” in line 5. By use of the parentheses, it is not clear if the “(preload)” is meant to be further limiting the compression spring or if it is meant to be exemplary. Claim 4 recites the limitation " the hardness " in line 1 . There is insufficient antecedent basis for this limitation in the claim. Claim 5 recites the limitation " the hardness " in line 1 . There is insufficient antecedent basis for this limitation in the claim. Claim 7 recites the limitation "the dose" in line 4. There is insufficient antecedent basis for th is limitation in the claim. Claim 7 recites “a compression spring (preload)” in line 5. By use of the parentheses, it is not clear if the “(preload)” is meant to be further limiting the compression spring or if it is meant to be exemplary. Claim 8 recites the limitation "the hardness" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 2, 3, and 6 are rejected based solely on their dependency to rejected claims. 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 6 is 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. Claim 6 is a duplicate claim since all of the limitations have already been recited in claim 1, from which it depends. 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 § 102 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 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 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)(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. (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, 3, and 6 are rejected under 35 U.S.C. 102 (b) as being anticipated by Holroyd (US 2004/0025867) . As to claim 1, Holroyd discloses a breath actuated inhaler device (Fig. 1) comprising: an actuator housing 400; canister 25 and; a pneumatic force holding unit (Fig. 8) for triggering the dose in response to breathe; wherein pneumatic force holding unit comprising a compression spring (preload) 460 (Fig. 8, paragraph [0033]) , a lower cap 420 that engages the canister 25 (see Fig. 1) , a diaphragm 640 (Figs. 4-8) attached to an upper surface of the lower cap 420 (Fig. 8, paragraph [00 56 ]) , and a flap (valve seal/flap 540) to seal a valve port 6 95 located in the diaphragm 640 (paragraph [00 57 ]) , wherein the diaphragm 6 40 includes a central rigid disk 6 41 and a peripheral flexible polymer ring 64 7 for triggering the dose in response to breathe (Figs. 4-8, paragraph [0056]) , wherein the central rigid disk 6 41 of the diaphragm 640 is provided with the interlocking means (axial grooves 708 ) to firmly secure and bound the peripheral flexible polymer ring 6 47 with the central rigid disc 6 41 of the diaphragm 6 40 ( see Figs. 6-7, paragraph s [0054]- [0055] ; see also applicant’s specification on page 3, lines 19-21, which describes “interlocking means” as “one or more grooves or cavities” ) . As to claim 3, Holroyd discloses the breath actuated inhaler device according to claim 1, wherein a central rigid disk 641 and a peripheral flexible polymer ring 647 of diaphragm 640 is formed by two shot injection molding process (paragraph [0033]) . As to claim 6, Holroyd discloses the breath actuated inhaler device according to claim 1, wherein a central rigid disk 641 of the diaphragm 640 is provided with the interlocking means 708 to firmly secure and bound the peripheral flexible polymer ring 647 with the central rigid disc 641 (Figs. 6-7, paragraph [0055]). 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 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. Claim s 2, 5, 7, and 8 ar e rejected under 35 U.S.C. 103 as being unpatentable over Holroyd (US 2004/0025867), in view of Stenzler et al. (US 2018/0093051) . As to claim 2, Holroyd discloses the breath actuated inhaler device according to claim 1, but does not expressly disclose that the flap consists of a soft elastomer component to form an air tight lock with the valve port of the diaphragm. However, Stenzler discloses a valve seal/flap 142 which is formed of a soft elastomer material to form an air tight lock with a valve port 140 (Figs. 6A-6C, 7A-7B, paragraph [0042]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Holroyd so that the flap/valve seal 540 is made of a soft elastomer, as taught by Stenzler, in order to provide a suitable material choice for sealing the valve port and allowing flexure upon inhalation pressure. As to claim 5, Holroyd discloses the breath actuated inhaler device according to claim 2, wherein the hardness of the soft elastomer component is between 5-20 Shore A (see Stenzler, paragraph [0042]: valve 142 material may be silicone rubber or similar hyper-elastic material having a durometer between 5 and 80, preferably between 10 and 40). As to claim 7, Holroyd discloses a breath actuated inhaler device (Fig. 1) comprising: an actuator housing 400; canister 25 and; a pneumatic force holding unit (Fig. 8) for triggering the dose in response to breathe; wherein pneumatic force holding unit comprising a compression spring (preload) 460 (Fig. 8, paragraph [0033]), a lower cap 420 that engages the canister 25 (see Fig. 1), a diaphragm 640 (Figs. 4-8) attached to an upper surface of the lower cap 420 (Fig. 8, paragraph [0056]), and a flap (valve seal/flap 540) to seal a valve port 695 located in the diaphragm 640 (paragraph [0057]), Holroyd does not expressly disclose that the flap consists of a soft elastomer component to form an air tight lock with the valve port of the diaphragm. However, Stenzler discloses an inhaler device having a valve seal/flap 142 which is formed of a soft elastomer material to form an air tight lock with a valve port 140 ( Figs. 6A-6C, 7A-7B, paragraph [0042] ). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Holroyd so that the flap/valve seal 540 is made of a soft elastomer, as taught by Stenzler, in order to provide a suitable material choice for sealing the valve port and allowing flexure upon inhalation pressure. As to claim 8, modified Holroyd discloses the breath actuated inhaler device according to claim 7, wherein the hardness of the soft elastomer component is between 5-20 Shore A (see Stenzler, paragraph [0042]: valve 142 material may be silicone rubber or similar hyper-elastic material having a durometer between 5 and 80 , preferably between 10 and 40 ) . Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holroyd (US 2004/0025867), in view of Gilbert et al. (US 2014/0053835 ). As to claim 4, Holroyd discloses the breath actuated inhaler device according to claim 1, but does not expressly disclose that the hardness of the flexible polymer ring (portion 647 of diaphragm 640) is between 55-75 Shore A. However, Gilbert teaches a gas dispenser having a diaphragm 206 (Fig. 5) made of elastomer material having a hardness between 40-50 (paragraph [0061]: silicone material having a Shore A hardness ranging from 40-90 or from about 50 to 80). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Holroyd so that the flexible polymer ring of the diaphragm is made of a material having a hardness within the claim range , as taught by Gilbert , in order to provide a suitable material choice allowing flexure of the material upon increased pressure . Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zeng et al. (US 2014/0373832 ) discloses a breath actuated inhaler having a diaphragm, compression spring and valve seal flap. Buck et al. (US 2018/0228989) discloses a breath actuated inhaler having a diaphragm, compression spring and flap valve. Walsh et al. (US 2019/0262602) discloses a breath actuated inhaler having a diaphragm, compression spring and flap valve. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT VALERIE L WOODWARD whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1479 . The examiner can normally be reached on FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:30 am - 4:30 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, KENDRA CARTER can be reached on 571-272-9034 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /VALERIE L WOODWARD/ Primary Examiner, Art Unit 3785