Prosecution Insights
Last updated: April 19, 2026
Application No. 19/103,358

PACKAGING MEMBER FOR A PHOTOSENSITIVE DRUG SUBSTANCE

Non-Final OA §102§103§112
Filed
Feb 12, 2025
Examiner
GEHMAN, BRYON P
Art Unit
3736
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Hoffmann-La Roche, Inc.
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
2y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
1435 granted / 1949 resolved
+3.6% vs TC avg
Strong +31% interview lift
Without
With
+30.8%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 1m
Avg Prosecution
46 currently pending
Career history
1995
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
51.0%
+11.0% vs TC avg
§102
5.5%
-34.5% vs TC avg
§112
23.7%
-16.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1949 resolved cases

Office Action

§102 §103 §112
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 . 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. Claims 1-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. In claim 1, line 2, the term “sheet-like” renders the claims indefinite because the claims include elements not actually disclosed (those encompassed by the indefinite scope of "like"), thereby rendering the scope of the claims unascertainable. See MPEP § 2173.05(d). In claim 1, line 7, the indefinite phrasing “and/or”(due to the slash) is indefinite, as is the phrase of line 6 beginning “of at least one of…” as the phrase is directed to one of a group, not alternatives. In line 7, “and/or” should just be --and--. The phrases incorporating the indefinite “and/or” in each of claims 2, 3, and 4 are similarly indefinite, as applicant is referencing “of at least..” from a defined group, not alternatives, and in each case “and/or” should just be --and--. Beginning in claim 7, line 3 (twice) and line 4, the word “preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase in each instance are part of the claimed invention. See MPEP § 2173.05(d). See also claim 11, line 4, claim 14, line 3, claim 15, line 4, claim 16, line 3, claim 17, lines 2 and 4, and claim 18, line 3 for other instances of the indefinite “preferably”. In claim 8, line 3, the indefinite “and/or” is employed. In line 2, “wherein” should be followed by --at least one of the front wall member…-- and “and/or” in line 3 be changed to --and--. In claim 9, line 3, the indefinite “and/or” is employed. In line 2, “comprise” should be followed by –at least one of front…- and in line 3, “and/or” changed to --and--. In claim 11, line 2, “the side wall member opposite from the side wall member with the bonding flap” lacks antecedent basis from parent claim 1. In claim 12, line 2, “the uncoloured field” lacks antecedent basis from parent claim 1. In claim 13, line 2, “the folding lines formed between the individual side wall members” lacks antecedent basis from parent claim 1. In line 3, “the side wall member with the bonding flap” lacks antecedent basis from parent claim 1. In claim 14, line 2, “the bonding flap” lacks antecedent basis from parent claim 1. In claim 15, line 2, “the side wall member opposite from the side wall member with the bonding flap” lacks antecedent basis from parent claim 1. In line 4, “the bonding section of the bonding flap” lacks antecedent basis from parent claim 1. In claim 16, line 2, “the side wall member with the bonding flap” lacks antecedent basis from parent claim 1. In lines 3-4, “the attachment portion of the shielding section of the bonding flap” lacks antecedent basis from parent claim 1. In claim 17, lines 2-3, “the side wall member facing the side wall member with the bonding flap” lacks antecedent basis from parent claim 1. In line 3, “the assembled state” lacks antecedent basis as what such defines. In claim 18, lines 1-2, “the side wall member with the rear side flap” lacks antecedent basis from parent claim 1. In lines 3-4, “the attachment portion of the rear side flap” lacks antecedent basis from parent claim 1. 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. Claims 1-7, 20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020021049. Claims 1-10, 19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 1151924. Each discloses a packaging member (100; 10, see Figure 1 and paragraph 0002; respectively) capable of receiving a photosensitive drug substance being made of a substantially stiff sheet material (cardboard; see paragraph 0033, cardboard) defining an outer packaging surface and an inner packaging surface (see Figure 1; see Figure 1 and paragraphs 0021-0022), the packaging member comprises a front wall member (lid, see Figure 1; 15) , a rear wall member (opposite the lid of Figure 1; 27) and at least two to four side wall members (forming the four-sided parallepiped portion of 100; 18, 19, 19, 22, 23, 23, 25, 25) characterized in that the inner packaging surface of at least one of the front wall member, the rear wall member and the at least four side wall members comprises a color (black light absorbing ink; black, see paragraph 0048) adapted to provide for a light absorption of at least 50% (by applicant’s disclosure, the color black will provide for a light absorption of at least 50%). As to claims 2-6, each discloses the inner packaging surface of the front wall member (lid; 15), the rear wall member (opposite the lid; 27) and the at least four side wall members (the four-sided parallelepiped portion of 100; 18, 19, 19, 22, 23, 23, 25, 25) comprise a color (11; see paragraphs 0048 and 0049). As to claim 7, the color (black) is inherently adapted to provide for light absorption of 75% to 100%. As to claim 8, EP 1151924 discloses the rear wall member (27) comprises a rear closure flap (14). As to claim 9, EP 1151924 discloses wherein at least two of the side wall members (18, 19, 19, 22, 23, 23, 25, 25) comprise front side flaps (19, 19) and rear side flaps (25, 25). As to claim 10, EP 1151924 discloses wherein at least one (18) of the side wall members comprises a bonding flap. As to claim 19, EP 1151924 discloses wherein at least one (22) of the side wall members comprises an access opening (16). As to claims 20 and 21, WO 2020021049 discloses a light absorbing black ink applied by printing providing a coating of black ink to absorb light. As to claim 22, EP 1151924 discloses wherein the packaging member (10) is in the form of a secondary packaging (inner packaging of Figure 2) defining a receiving space in a primary packaging.(outer packaging of Figure 2). 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 1-10, 19 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over EP 1151924 in view of WO 2017/055884. EP 1151924 discloses a packaging member (10, see Figure 1 and paragraph 0002) capable of receiving a photosensitive content being made of a substantially stiff sheet material (see paragraph 0033, cardboard) defining an outer packaging surface and an inner packaging surface (see Figure 1 and paragraphs 0021-0022), the packaging member comprises a front wall member (15) , a rear wall member (27) and at least two to four side wall members (18, 19, 19, 22, 23, 23, 25, 25) characterized in that the inner packaging surface of at least one of the front wall member, the rear wall member and the at least four side wall members comprises a color (black, see paragraph 0048) adapted to provide for a light absorption of at least 50% (by applicant’s disclosure, the color black will provide for a light absorption of at least 50%). EP 1151924 does not specifically disclose a drug substance as the content. However, WO 2017/055884 disclose a similar packaging member designed to receive a drug substance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the light absorption packaging member of EP 1151924 with the light protected content of a photosensitive drug substance in the manner of WO 2017/055884 as claimed, as such a modification would predictably provide protection of a photosensitive drug substance from light degradation. As to claims 2-6, EP 1151924 disclose the inner packaging surface of the front wall member (15), the rear wall member (27) and the at least four side wall members (18, 19, 19, 22, 23, 23, 25, 25) comprise a color (see paragraphs 0048 and 0049). As to claim 7, EP 1151924 disclose the color (black) is adapted to provide for light absorption of 75% to 100%. As to claim 8, EP 1151924 disclose the rear wall member (27) comprises a rear closure flap (14). As to claim 9, wherein EP 1151924 disclose at least two of the side wall members (18, 19, 19, 22, 23, 23, 25, 25) comprise front side flaps (19, 19) and rear side flaps (25, 25). As to claim 10, wherein EP 1151924 disclose at least one (18) of the side wall members comprises a bonding flap (engaging 24, 28 and 24). As to claim 19, wherein EP 1151924 disclose at least one (22) of the side wall members comprises an access opening (16). As to claim 22, wherein EP 1151924 disclose the packaging member (10) is in the form of a secondary packaging (inner packaging of Figure 2) defining a receiving space in a primary packaging.(outer packaging of Figure 2). As to claim 23, WO 2017/055884 discloses a drug substance as the content, and the light protection packaging member of EP 1151924 would be usable with a drug substance requiring light protection. Claims 11-13, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the art as applied to claim 1 above, and further in view of Ellsworth (2,649,239). The previous art does not disclose limiting the colored and uncolored extent of the inner packaging surface. However, Ellsworth discloses it was known to limit the colored area of an inner packaging surface (see column 3, lines 6-14) to avoid glue areas. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the packaging member of EP 1151924, alone or in combination with WO 2017/055884 with limited coloring of the inner surface in the manner of Ellsworth as claimed, as such a modification would predictably provide facilitated gluing of the packaging member by leaving the glued surface uncolored, and set a degree of light absorption by the amount of color. It has been held that omission (or limitation) of an element and its function in a combination where the remaining elements perform the same function as before involves only routine skill in the art. In re Karlson, 136 USPQ 184 Claims 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over EP 1151924, alone or in combination, as applied to claim 1 above, and further in view of Rosenburg (3,575,286). The previous art does not disclose the packaging member having a bonding flap comprising a bonding section and a shielding section including an attachment portion. However, Rosenburg discloses a similar packaging member having a bonding flap (13, 15 and 16) comprising a bonding section (15) and a shielding section (16) including an attachment portion (6 or 17). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the packaging member of EP 1151924, alone or in combination with WO 2017/055884, with a packaging member securing arrangement in the manner of Rosenburg as claimed, as such a modification would predictably provide an expected secured carton arrangement. Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over the art as applied to claim 1 above, and further in view of WO 2020021049. The previous art does not disclose applying color by coating or printing. However, WO 2020021049 discloses a light absorbing black ink applied by printing providing a coating of black ink to absorb light. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the packaging member of packaging member of EP 1151924, alone or in combination with WO 2017/055884 with light absorbing black ink in the manner of WO 2020021049 as claimed, as such a modification would predictably provide a recognized manner of introducing ink to a packaging member. . Prior Art not relied upon: Please refer to the additional references listed on the attached PTO-892, which, while not relied upon for the claim rejection, these references are deemed relevant to the claimed invention as a whole. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYON P GEHMAN whose telephone number is (571) 272-4555. The examiner can normally be reached on Tuesday through Thursday from 7:30 am to 5:00 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, Orlando Aviles-Bosques, can be reached on (571) 270-5531. 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. /BRYON P GEHMAN/Primary Examiner, Art Unit 3736 Bryon P. Gehman Primary Examiner Art Unit 3736 BPG
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Prosecution Timeline

Feb 12, 2025
Application Filed
Mar 11, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+30.8%)
2y 1m
Median Time to Grant
Low
PTA Risk
Based on 1949 resolved cases by this examiner. Grant probability derived from career allow rate.

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