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 .
Status of the Claims
Claims 1, 5, 7, 9-10, 13-15, 17, 19-20 and 22-31 are pending.
Applicants’ arguments, filed on 07/01/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 07/01/2026, have been entered into the record. Applicants have amended claims 1, 5, 7, 9-10, 14, 17 and 19. Applicants have cancelled claims 2-4, 6, 8, 16, 18 and 21. Applicants have newly added claims 23-31. Therefore, claims 1, 5, 7, 9-10, 13-15, 17, 19-20 and 22-31 are subject of the Office Action below.
Claim Objections
Claims 9, 15, 19, 22, 25 and 28-30 are objected to under 37 CFR 1.71(a), because of the recitation of superfluous subject matter.
The recitation of “wherein the amount of the compound of formula (I) or the pharmaceutically acceptable salt thereof or the pharmaceutical composition thereof is based on the mass of the compound of formula (I), and the amount of letrozole or the pharmaceutical composition thereof is based on the mass of letrozole” in claim 9 is superfluous because a person skilled in the art would have readily understood that the recited amount of for example, the compound of formula (I), is based on the mass of the compound of formula (I). It is recommended that Applicants amend claim 9 to recite: “The combined pharmaceutical composition according to claim 1, wherein the combined pharmaceutical composition is in a form suitable for administration in a single treatment cycle of 28 days, and the composition comprises: 1680-5040 mg, 3360-5040 mg, or 5040 mg of the compound of formula (I) or the pharmaceutically acceptable salt thereof; and 70-140 mg, or 70 mg of the letrozole.” Appropriate correction is required.
Claims 15, 19, 22, 25 and 28-30 are similarly objected to as in claim 9 above. It is recommended that Applicants amend claims 15, 19, 22, 25 and 28 to recite:
Amend claim 15 to recite: “The method according to claim 10, wherein:
a) 28 days are counted as one treatment cycle;
b) the administration is performed once daily for 28 consecutive days; and
c) the therapeutically effective amount of the:
i) compound of formula (I) or the pharmaceutically acceptable salt thereof, administered per treatment cycle is 1680-5040 mg; and
ii) anastrozole administered per treatment cycle is 28-140 mg.”
Appropriate correction is required.
Amend claim 19 to recite: “The combined pharmaceutical composition according to claim 1, wherein the composition is in a form suitable for administration in a single treatment cycle of 28 days, and the composition comprises: 1680-5040 mg, 3360-5040 mg, or 5040 mg of the compound of formula (I) or the pharmaceutically acceptable salt thereof; and 28-140 mg, 28-56 mg, or 28 mg of the anastrozole.” Appropriate correction is required.
Amend claim 22 to recite: “The method according to claim 10, wherein:
a) 28 days are counted as one treatment cycle;
b) the administration is performed once daily for 28 consecutive days; and
c) the therapeutically effective amount of the:
i) compound of formula (I) or the pharmaceutically acceptable salt thereof, administered per treatment cycle is 1680-5040 mg; and
ii) letrozole administered per treatment cycle is 70-210 mg.”
Appropriate correction is required.
Amend claim 25 to recite: “The combination according to claim 24, comprising 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 150 mg, and/or 240 mg of the compound of formula (I) or the pharmaceutically acceptable salt thereof.” Appropriate correction is required.
Amend claim 28 to recite: “The method according to claim 10, wherein the therapeutically effective amount of the compound of formula (I) or the pharmaceutically acceptable salt thereof, is 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 150 mg, and/or 240 mg.” Appropriate correction is required.
Amend claim 29 to recite: “The method according to claim 10, wherein the therapeutically effective amount of the letrozole is 2.5 mg, 5 mg, 7.5 mg, or 10 mg.” Appropriate correction is required.
Amend claim 30 to recite: “The method according to claim 10, wherein the therapeutically effective amount of the anastrozole is 1 mg, 2 mg, 3 mg, or 4 mg.” Appropriate correction is required.
Maintained Rejections
Claim Rejections - 35 USC § 112-Maintained
New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
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 and 23 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 17 recites the broad recitation “1-5 mg, 1-4 mg, 1-3 mg, or 1-2 mg of anastrozole”, and the claim also recites “1 mg, 2 mg, 3 mg, or 4 mg of anastrozole”, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 23 recites the limitation “in their respective kits”, in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 23 lacks antecedent basis because claim 1 from which claim 23 depends does not recite a kit comprising the combine pharmaceutical composition. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Response to Applicants’ Arguments/Remarks
Applicants argue alleging that the rejection is overcome by the amendment of claim 17 (see page 6 of Remarks filed on 07/01/2026).
Response:
Claim 17 recites a broad range and narrow range within the same claim (see discussions above).
Claim Rejections - 35 USC § 103
Maintained/New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
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.
The rejection of claims 1, 5, 7, 9-10, 13-15, 17, 19-20 and 22, is maintained and newly added claims 23-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sun of record (CN107137408A, published 09/08/2017, Machine Translation& Original) in view of Ding of record (CA2978363, published 09/16/2016), for the reasons of record set forth in the previous Office action of which, said reasons are herein reiterated.
By way of a background, Applicants’ invention (see e.g., pages 1-2 of the specification), is directed to a method for treating breast cancer with a combination therapy comprising a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor compound of formula (I):
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and an aromatase inhibitor.
Under the broadest reasonable interpretation (BRI), consistent with the specification, the claimed invention is being interpreted as: i) composition comprising a compound of formula (I) and an aromatase inhibitor; and ii) a method for treating or preventing breast cancer in a subject in need thereof, comprising administering to the subject, composition comprising a compound of formula (I) and an aromatase inhibitor.
Similar to the Applicants’ invention (see discussions above), Sun teaches a method for treating breast cancer with a pharmaceutical composition comprising CDK4/6 inhibitor compound A:
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and an aromatase inhibitor compound selected from the group consisting of formestane, exemestane, fadrozole, letrozole, vorozole and anastrozole. Please see abstract, ¶s 0002, 0005-0013,0018- 0021, 0025-0027 and 0055-0062 of the Machine Translation and first page of original patent for structure of compound A. Compound A is also known in the art as PD0332991 (see e.g., ¶ 0025 of Machine Translation) or Palbociclib (see page 2 of Ding).
Clinical trial results (NCT00721409) showed that patients treated with letrozole monotherapy had a progression-free survival (PFS) of 7.5 months, while patients treated with letrozole in combination with PD-0332991 had a PFS extended to 26.1 months. This significant advantage has attracted widespread attention. Please see Machine Translation at ¶ 0005.
Sun differs from the claimed invention only insofar as Sun is not explicit in disclosing a compound of formula (I) as a CDK4/6 inhibitor.
However, the claimed invention would have been obvious over Sun, because at the time of the instant invention, it was known in the art that a compound of formula (I) is a CDK4/6 inhibitor. For example, similar to Sun (see discussions above), Ding teaches a method for treating breast cancer with compound Example 3 listed on page 35 (a compound of formula (I)), and with compound A of Sun. Please see pages 105-109. Compound Example 3 exhibited the highest rated activity level in an in vitro assay (see Table 1 on page 105), and was significantly superior in antitumor activities at lower dose (25 mg/kg), compared to Palbociclib at 45 mg/kg (see Table 4 on page 109).
Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method for treating a patient suffering from breast cancer with a composition comprising a CDK4/6 inhibitor compound Example 3 (a compound of formula (I)) and an aromatase inhibitor (e.g., letrozole). One skilled in the art would have had a reasonable expectation that the patients treated with a CDK4/6 inhibitor (e.g., compound Example 3, i.e., a compound of formula (I)) in combination with an aromatase inhibitor (e.g., letrozole), would exhibit a higher PFS extension, when compared to a monotherapy.
The use of simple substitution of one known element for another to obtain predictable results as a requirement of a prima facie case of obviousness has been deemed as proper (please see MPEP § 2143). In the instant case, the one known element is a CDK4/6 inhibitor and the predictable results is treating disease conditions such as breast cancer, in which the therapeutic intervention is at a CDK4/6 inhibition.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 1, 10, 13 and 24 are obvious over Sun and Ding.
Regarding claims 5, 7, 9, 15, 17, 19, and 25-30, each of the recited dosage ranges and the dosage scheduling is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. For example:
Sun discloses that:
i) the daily dosage of the CDK4/6 inhibitor can range from 0.1 mg/kg to 1000 mg/kg, preferably from 0.5 to 10 mg/kg, and more preferably from 0.5 to 5 mg/kg. For adults, the preferred daily dose is 1-100 mg, more preferably 10-500 mg, and most preferably, 30-300 mg. Please see ¶ 0018.
ii) the daily dosage of the aromatase inhibitor can range from 1-100 mg, preferably 1-10 mg, more preferably 1-5 mg. Please see ¶ 0019.
iii) the CDK4/6 inhibitor and the aromatase inhibitor can be in a weight ratio of, for example, 1-1000:1, preferably 10-100:1, more preferably 20-80:1. Please see ¶ 0020.
iv) the CDK4/6 inhibitor and the aromatase inhibitor can be administered simultaneously, sequentially or can be formulated into a pharmaceutical composition. Please see ¶ 0021.
v) NCT00721409 (see e.g., page 7), discloses treatment cycle of 3 weeks (21 days) or 4 weeks (28 days)
Ding (see page 12), states:
“For drugs or pharmacologically active agents, the term “an effective amount” or “a therapeutically effective amount” refers to an adequate amount of the drug that is non-toxic but capable of achieving the expected effect. For the oral dosage form in the present invention, “an effective amount” of an active agent in the composition refers to the amount of the active agent that is needed to achieve the expected effect when used in combination with another active agent in the composition. The determination of the effective amount varies from person to person and depends on the age and the general condition of the subjects. It also depends on the specific active agent. The suitable effective amount for individuals can be determined by those skilled in the art through routine experimentation.”
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed dosage ranges and the dosage scheduling recited in claims 5, 7, 9, 15, 17, 19, and 25-30.
Regarding claims 14, 20 and 31, Sun (see ¶ 0013), teaches ER-positive and HER2-negative breast cancer, more preferably locally advanced or metastatic breast cancer with the above phenotype.
Regarding claim 23, it is a standard of practice in the pharmaceutical arts to enclose a commercial package comprising therapeutic products that contain information about the indications, usage, dosage, administration, contraindications and/or warnings concerning the use of such therapeutic products. In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983), holds that when "printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability. Please see MPEP 2112.01(III). Therefore, at the time of the instant invention, one skilled in the art would have found it obvious to enclose a commercial package comprising the invention of Sun in view of Ding, in order to arrive at the invention of claim 23.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Response to Applicants’ Arguments/Remarks
Applicants raised several issues (see pages 6-10 of Remarks filed on 07/01/2026), alleging that instant claims are non-obvious over the cited prior art on the grounds that:
1) a person skilled in the art would not have had a reasonable expectation of success in treating breast cancer in a human patient with a combination of compound A and letrozole, because Sun teaches treating breast cancer in mice (see page 7 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because, Applicants provide evidence that breast cancer in a human patient can be treated with a combination of Palbociclib (PD-0332991 or compound A, see discussions above) and letrozole (Qianqian Guo et al, Targeted Oncology, 2019, 14, 139-148, Exhibit 2 submitted by the Applicants, see page 8 of Remarks). Furthermore, Sun discloses that clinical trial results (NCT00721409) showed that patients treated with letrozole monotherapy had a progression-free survival (PFS) of 7.5 months, while patients treated with letrozole in combination with PD-0332991 had a PFS extended to 26.1 months (see discussions above).
2) although both compound A of Sun and the claimed compound of formula (I) are CDK4/6 inhibitors, a person skilled in the art would not have had a reasonable expectation of success in treating breast cancer with a combination of the claimed compound of formula (I) and an aromatase inhibitor (e.g., letrozole). Applicants cite Angiolillo et al, Clinical Pharmacology & Therapeutics, 2011,89(1), 65-74, submitted by the Applicants as Exhibit 1, in support of the Applicants’ allegations (see page 7 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because, Applicants’ arguments are not commensurate in scope with the claimed invention. The claimed invention is directed to a breast cancer combination therapy comprising CDK4/6 inhibitor (a compound of formula (I)) and an aromatase inhibitor (e.g., letrozole), whereas, the Applicants are arguing about combination use of proton-pump inhibitor (PPI) and clopidogel.
3) Applicants have surprisingly and unexpectedly discovered that subjects receiving the combination therapy of the compound of formula (I) and letrozole or anastrozole, have:
a) overall incidence grade 3 treatment-related adverse events (TRAEs) of only 27.9% and no grade 4-5 TRAEs and treatment-related deaths were observed, citing Example1 of the specification, whereas, Guo et al, Targeted Oncology, 2019, 14, 139-148, submitted by the Applicants as Exhibit 2, teaches that: i) palbociclib (a CDK4/6 inhibitor) in combination with letrozole, grade 3 TRAE was 85%; and ii) ribociclib (a CDK4/6 inhibitor) in combination with letrozole, grade 3 TRAE was 89.6%. Please see page 8 of Remarks.
b) objective responsive rate (ORR) of 65.7% and clinical benefit rates (CBRs) of cohort II and cohort I of 90.6% and 100% respectively, citing Example1 of the specification, whereas:
i) Finn et al, Lancet Oncol., 2015, 16, 25-35, submitted by the Applicants as Exhibit 3, teaches that in a combination of palbociclib and letrozole, ORR was 42.9% or 55.4% and CBR was 80%. Please see page 9 of Remarks.
ii) Hortobagyi et al, New Engl. J. Med., 2016, 375, 1738-1748, submitted by the Applicants as Exhibit 4, teaches that in a combination of ribociclib and letrozole, ORR was 40.79% or 52.7% and CBR was 79.6 or 80.1%. Please see page 9 of Remarks.
iii) Goetz et al, J. Clinical Oncology., 2017, 35(32), 3638-3646, submitted by the Applicants as Exhibit 5, teaches that in a combination of abemaciclib and letrozole/anastrozole, ORR was 48.2% or 59.2% and CBR was 78.0%. Please see page 9 of Remarks.
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive. The presented evidence of secondary consideration such as unexpected success are not probative because the Applicants’ evidence is presented in the form of an attorney statement. Regarding the probative value of objective evidence:
1) MPEP § 716 states: “When any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under this section”; and
2) MPEP § 716.01(c)(II), under the title “ATTORNEY ARGUMENTS CANNOT TAKE THE PLACE OF EVIDENCE”, states: “The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor”.
Furthermore, a review of the specification (including Example 1), fails to reveal any data regarding what biomarkers were measured in order to arrive at the observed: i) grade 3 TRAE of 27.9%; ii) ORR of 65.7% and iii) CBRs of cohort II and cohort I of 90.6% and 100%. Therefore, a person skilled in the art would not be able to make any meaningful interpretation of the Applicants’ results. It is noted that each of the references cited by the Applicants provide data regarding what biomarkers were measured in order to arrive at the observed results. Applicants also fail to mention that Goetz et al teaches that in a combination of abemaciclib and letrozole/anastrozole, the grade 3 adverse event was 21.1% (see abstract), as against 27.9% observed by the Applicants’ invention (see discussions above).
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Non-Statutory Obviousness-Type Double Patenting-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1, 5, 7, 9-10, 13-15, 17, 19-20 and 22, is maintained and newly added claims 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of:
1) U.S. Patent Application No. 18/547,410 (‘410 application) in view of: 1) Sun of record (CN107137408A, published 09/08/2017, Machine Translation& Original); and 2) Ding of record (CA2978363);
2) U.S. Patent Application No. 18/011,759 (‘759 application) in view of: 1) Sun of record (CN107137408A, published 09/08/2017, Machine Translation& Original); and 2) Ding of record (CA2978363); and
3) U.S. Patent Application No. 19/152,755 (‘755 application),
for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants raised several issues (see pages 10-11 of Remarks filed on 07/01/2026), alleging that the rejections are improper on the grounds that:
1) the ‘410 application claims are directed to a composition a compound of formula (I) and Fulvestrant, and instant claims are non-obvious over Sun of record and Ding of record for the reasons discussed above (see page 11 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because, Applicants’ arguments on the grounds that the instant claims are non-obvious over Sun of record and Ding of record, have been addressed in the discussions above. The Examiner, therefore, applies the response hereto. Therefore, the use Sun of record and Ding of record for the rejection instant claims on the ground of nonstatutory double patenting as being unpatentable over claims of ‘410 application, is proper.
2) the ‘755 application claims directed to a composition comprising a compound of formula (I) and an endocrine therapeutic agent (see page 11 of Remarks)
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because, the ‘755 application claims (e.g., claims 16-20) are directed to a composition comprising a compound of formula (I) and an endocrine therapeutic agent selected from the consisting of a list that include an aromatase inhibitor (e.g., letrozole and anastrozole). Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
3) the ‘759 application claims are directed to a method for making a compound of formula (I), and instant claims are non-obvious over Sun of record and Ding of record for the reasons discussed above (see page 11 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because, Applicants’ arguments appear to be a reiteration of the same arguments above, which have been addressed in the discussions above. The Examiner, therefore, applies the response hereto. Therefore, the use Sun of record and Ding of record for the rejection instant claims on the ground of nonstatutory double patenting as being unpatentable over claims of ‘759 application, is proper.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
Applicant's amendment necessitated the new ground(s) 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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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